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1

<span class="highlight">T</span> <span class="highlight">cell</span> Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors

Purpose: To study the safety, anti-cancer activity and side effects of giving an experimental immunotherapy made from <span class="highlight">cells</span> from your own immune system.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood <span class="highlight">cells</span> to make the immunotherapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">CRX100, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">A hospital stay may be required</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CRX100 is the name of the immunotherapy used in this trial. It may work by directly killing cancer <span class="highlight">cells</span> and by getting the immune system to go after and kill cancer <span class="highlight">cells.</span> </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04282044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bioeclipse.com/clinical-trials-overview/' target='_blank'>BioEclipse Therapeutics Drug Information Page: CRX1000</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/25381063/' target='_blank'>Journal Article Abstract: Cytokine-Induced Killer (CIK) Cells in Cancer Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Leukapheresis' target='_blank'>Wikipedia: Leukapheresis</a> </li></ul>
1

<span class="highlight">T</span> <span class="highlight">cell</span> Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors
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Nearest Location:
29 miles
Stanford University
Stanford, CA

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Visits:
May require hospital stay

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ClinicalTrials.gov: NCT04282044

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Phase I

2

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR <span class="highlight">T</span> <span class="highlight">Cells,</span> in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of LYL797, an experimental type of immunotherapy called CAR T-cell therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR1 positive breast cancer that has progressed on standard treatment. You must not have received T-cell therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 CAR T-cell therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 1 biopsy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. Hospital stay may be required.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 is an experimental type of immunotherapy called CAR T-cell/CAR-T therapy.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR <span class="highlight">T</span> <span class="highlight">cell</span> therapy is a personalized immunotherapy made from your white blood <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">The <span class="highlight">cells</span> are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer <span class="highlight">cells,</span> and then put back in your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack ROR1 positive cancer <span class="highlight">cells</li></span> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of ROR1 positive cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR1</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05274451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://lyell.com/our-pipeline' target='_blank'>Lyell Immunopharma Drug Information Page: LYL797</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/' target='_blank'>Dana-Farber Cancer Institute: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-adoptive-cell-therapy' target='_blank'>Breastcancer.org: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>
2

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR <span class="highlight">T</span> <span class="highlight">Cells,</span> in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies
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Nearest Location:
341 miles
University of California, Los Angeles
Santa Monica, CA

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Visits:
Hospital stay may be required

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ClinicalTrials.gov: NCT05274451

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Phase I

3

GEN1047 for Stage III or Stage IV Breast Cancer

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of GEN1047, an experimental immunotherapy.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) breast cancer who have progressed after or during at least one prior therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GEN1047, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GEN1047 is a bispecific antibody that helps <span class="highlight">T</span> <span class="highlight">cells</span> kill cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05180474' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genmab.com/pipeline/' target='_blank'>Genmab: GEN1047</a> </li></ul>
3

GEN1047 for Stage III or Stage IV Breast Cancer

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors
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Nearest Location:
341 miles
UCLA Department of Medicine Hematology Oncology
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05180474

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Phase I-II

4

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous <span class="highlight">T</span> <span class="highlight">Cells</span> Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 Specific for a Cleaved Form of MUC1 (MUC1*)

Purpose: To look at the safety, best dose and effects of an experimental CAR T-cell immunotherapy that targets cancer <span class="highlight">cells</span> that test positive for MUC1*, a special type of the MUC1 protein.

Who is this for?: People with metastatic (stage IV) breast cancer that tests positive for MUC1 and who have already received at least one standard therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood <span class="highlight">cells</span> to make your personalized CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Chemotherapy to deplete your lymph <span class="highlight">cells</span></li> <li class="seamTextUnorderedListItem">huMNC2-CAR44 CAR T-cells, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. Hospital stay may be required.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR <span class="highlight">T</span> <span class="highlight">cell</span> or CAR-T <span class="highlight">cell</span> therapy is a personalized immunotherapy made from your white blood <span class="highlight">cells.</span> </li> <li class="seamTextUnorderedListItem">Your blood <span class="highlight">cells</span> are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack MUC1 on cancer <span class="highlight">cells.</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04020575' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/car-t-cell-therapy.html' target='_blank'>MD Anderson Cancer Center: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/research/car-t-cells' target='_blank'>NCI: Car T-Cells</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.minervabio.com/clinical-trial-humnc2-car44-in-mbc/' target='_blank'>Minerva Biotechnologies: Study Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>
4

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous <span class="highlight">T</span> <span class="highlight">Cells</span> Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 Specific for a Cleaved Form of MUC1 (MUC1*)
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Nearest Location:
355 miles
City of Hope Medical Center
Duarte, CA

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT04020575

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Phase I

5

CAR T-Cell Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases

A Phase 1 <span class="highlight">Cellular</span> Immunotherapy Study of Intraventricularly Administered Autologous HER2-Targeted Chimeric Antigen Receptor (HER2-CAR) <span class="highlight">T</span> <span class="highlight">Cells</span> in Patients With Brain and/or Leptomeningeal Metastases From HER2 Positive Cancers

Purpose: To study the safety, best dose, and effects (good and bad) of a CAR T-cell immunotherapy that is delivered directly into the brain.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with brain or leptomeningeal metastases. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood <span class="highlight">cells</span> to make your HER2 CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Surgery to place a device (similar to a chemotherapy port) under your scalp</li> <li class="seamTextUnorderedListItem">HER2 CAR T-cells, by injection, weekly, 3 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. Hospital stay may be required.</i> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Follow up</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Every 2 months for 1 year, then every year for 15 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR <span class="highlight">T</span> <span class="highlight">cell</span> therapy is a personalized immunotherapy made from your white blood <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">Your blood <span class="highlight">cells</span> are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack HER2+ cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">You will have surgery to insert a device under your scalp so that the CAR T-cell therapy can be infused directly into your brain.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03696030' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cityofhope.org/physician-news/breast-cancer-car-t-cell-therapy' target='_blank'>City of Hope Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-cell Therapy and Its Side Effects</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li></ul>
5

CAR T-Cell Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases

A Phase 1 <span class="highlight">Cellular</span> Immunotherapy Study of Intraventricularly Administered Autologous HER2-Targeted Chimeric Antigen Receptor (HER2-CAR) <span class="highlight">T</span> <span class="highlight">Cells</span> in Patients With Brain and/or Leptomeningeal Metastases From HER2 Positive Cancers
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Nearest Location:
355 miles
City of Hope Medical Center
Duarte, CA

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT03696030

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Phase I

6

CAR-T <span class="highlight">Cell</span> Immunotherapy & Immunotherapy Injected Directly into Tumors for Metastatic HER2 Positive Breast Cancer

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR <span class="highlight">T</span> <span class="highlight">Cells</span> in Patients With Advanced HER2 Positive Solid Tumors

Purpose: To study the safety, anti-cancer activity and other effects (good and bad) of giving a HER2-specific CAR-T <span class="highlight">Cell</span> immunotherapy and an immunotherapy injected directly into a tumor.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAdVEC, by injection directly into a tumor, one time</li> </ul> <p class="seamTextPara"> followed by </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2-specific CAR-T <span class="highlight">Cell</span> therapy, by IV, one time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. Hospital stay may be required.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR-T is a personalized immunotherapy made from your white blood <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">The <span class="highlight">cells</span> are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer <span class="highlight">cells,</span> and then put back in your body.</li> <li class="seamTextUnorderedListItem">CAdVEC is an oncolytic adenovirus--this means it targets and kills cancer <span class="highlight">cells.</span> It may directly kill cancer <span class="highlight">cells</span> and stimulate your immune system to go after and kill cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">CAdVEC is injected directly into a tumor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2 positive cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03740256' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ncit.nci.nih.gov/ncitbrowser/pages/concept_details.jsf?dictionary=NCI_Thesaurus&version=20.07d&code=C158743&ns=ncit&type=all&key=null&b=1&n=0&vse=null' target='_blank'>NCI Thesaurus: CAdVEC</a> </li></ul>
6

CAR-T <span class="highlight">Cell</span> Immunotherapy & Immunotherapy Injected Directly into Tumors for Metastatic HER2 Positive Breast Cancer

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR <span class="highlight">T</span> <span class="highlight">Cells</span> in Patients With Advanced HER2 Positive Solid Tumors
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Nearest Location:
1644 miles
Baylor St. Luke's Medical Center
Houston, TX

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Visits:
May require hospital stay

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ClinicalTrials.gov: NCT03740256

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Phase I

7

A T-Cell Immunotherapy (HER2 BATs) and Keytruda for Women With Metastatic Breast Cancer

A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated <span class="highlight">T</span> <span class="highlight">Cells</span> (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer

Purpose: To investigate the safety and effects (good and bad) of combining the PD-1 inhibitor Keytruda with an immunotherapy made from your T-cells.

Who is this for?: Women with metastatic (stage IV) breast cancer. You must have had two or more prior therapies (chemotherapy or hormonal) for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood <span class="highlight">cells</span> (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once during week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood <span class="highlight">cells</span> (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, twice, during week 3-4 and week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood <span class="highlight">cells</span> (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, three times, before BATs, during week 3-4 and week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. May require hospitalization</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">HER2 bispecific antibody armed <span class="highlight">T</span> <span class="highlight">cells</span> (BATs) are an experimental type of T-cell immunotherapy. </li> <li class="seamTextUnorderedListItem">The HER2 BATs will be made by collecting white blood <span class="highlight">cells</span> from your body. Your white blood <span class="highlight">cells</span> will then be modified in a lab so they can identify and attack cancer <span class="highlight">cells.</span> These modified <span class="highlight">cells</span> will then be infused back into your body.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03272334' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/her2bi-armed-activated-t-cells' target='_blank'>NCI Drug Dictionary: HER2Bi-armed ATCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4839366/' target='_blank'>OncoImmunology: HER2 BATs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwt-L2BRA_EiwAacX32ZWZ-hf-RSddVt1Y8_oFJEJzejiyhC9eCFhl1JG4WlqWBf2Aq3rrXhoCf7AQA' target='_blank'>Merck Oncology Drug Information Page: Keytruda®</a> </li></ul>
7

A T-Cell Immunotherapy (HER2 BATs) and Keytruda for Women With Metastatic Breast Cancer

A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated <span class="highlight">T</span> <span class="highlight">Cells</span> (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer
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Nearest Location:
2377 miles
Ashley Donihee
Charlottesville, VA

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Visits:
1-2 visits a week for 7 weeks, may require hospitalization

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ClinicalTrials.gov: NCT03272334

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Phase I-II

8

PRGN-3007 CAR <span class="highlight">T</span> <span class="highlight">Cell</span> Therapy for Advanced Triple Negative, ROR-1 Positive Breast Cancer

A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T <span class="highlight">Cells</span> in Patients With Advanced Hematologic and Solid Tumor Malignancies

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of PRGN-3007 CAR T-cells, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR-1 positive breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR T-cells</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR-T or CAR <span class="highlight">T</span> <span class="highlight">cells</span> are an experimental personalized immunotherapy made from your white blood <span class="highlight">cells.</span> The white blood <span class="highlight">cells</span> are removed from your body and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. These white blood <span class="highlight">cells</span> are then infused into your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study trains the immune system to attack cancer <span class="highlight">cells</span> that test positive for the protein ROR-1.</li> <li class="seamTextUnorderedListItem">Before you receive PRGN-3007 T-cells, you will be given the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your immune system to receive the immunotherapy.</li> <li class="seamTextUnorderedListItem">Leukapheresis is a procedure to collect your white blood <span class="highlight">cells</span> to make your personalized CAR T-cell therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR-1</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05694364' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://precigen.com/pipeline/' target='_blank'>Precigen: PRGN-3007 Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapies/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-Cell Therapy</a> </li></ul>
8

PRGN-3007 CAR <span class="highlight">T</span> <span class="highlight">Cell</span> Therapy for Advanced Triple Negative, ROR-1 Positive Breast Cancer

A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T <span class="highlight">Cells</span> in Patients With Advanced Hematologic and Solid Tumor Malignancies
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Nearest Location:
2396 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT05694364

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Phase I

9

T-Cell Therapy, Dendritic <span class="highlight">Cell</span> Vaccine & Targeted Therapy for HER2+ Metastatic Breast Cancer

Phase 1 Study of Adoptive <span class="highlight">T</span> <span class="highlight">Cell</span> Therapy Following HER2-Pulsed Dendritic <span class="highlight">Cell</span> Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of T-cell therapy after dendritic <span class="highlight">cell</span> vaccines with pepinemab, an experimental targeted therapy, and trastuzumab (Herceptin®), a HER2-targeted therapy.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that progressed on trastuzumab (Herceptin®). You must not have received more than 3 lines of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic <span class="highlight">cell</span> vaccine, by injection, weekly for 6 weeks</li> <li class="seamTextUnorderedListItem">Pepinemab, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> followed by (2 weeks after last vaccine): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">T-cell therapy, by IV, 2 sessions over 2 weeks</li> <li class="seamTextUnorderedListItem">Dendritic <span class="highlight">cell</span> vaccine, by injection, every 3 weeks for at least 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis to collect your <span class="highlight">T</span> <span class="highlight">cells</span></li> <li class="seamTextUnorderedListItem">May require hospital stay</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a type of immunotherapy made from your white blood <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">Your T-cells are removed from your body during a process called leukapheresis, modified with CD4+ that allows them to attack HER2 positive cancer <span class="highlight">cells,</span> and then infused back into your body.</li> <li class="seamTextUnorderedListItem">Before you receive the T-cells, you will be treated with the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your body to receive the T-cells.</li> <li class="seamTextUnorderedListItem">Dendritic <span class="highlight">cell</span> vaccines are a type of immunotherapy that boosts the immune system to recognize and destroy cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">Pepinemab is an experimental targeted therapy called a SEMA4D inhibitor. Blocking SEMA4D may stop or slow cancer <span class="highlight">cells</span> from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a HER2-targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">After receiving the modified T-cells, you will continue to receive pepinemab, trastuzumab (Herceptin®), and booster doses of the dendritic <span class="highlight">cell</span> vaccine every 3 weeks.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05378464' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adoptive-cell-therapy' target='_blank'>National Cancer Institute: Adoptive T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.vaccinex.com/pipeline/pepinemab-immuno-oncology/' target='_blank'>Vaccinex Drug Information Page: Pepinemab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
9

T-Cell Therapy, Dendritic <span class="highlight">Cell</span> Vaccine & Targeted Therapy for HER2+ Metastatic Breast Cancer

Phase 1 Study of Adoptive <span class="highlight">T</span> <span class="highlight">Cell</span> Therapy Following HER2-Pulsed Dendritic <span class="highlight">Cell</span> Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer
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Nearest Location:
2396 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
May require hospital stay

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ClinicalTrials.gov: NCT05378464

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Phase I

10

<span class="highlight">T</span> <span class="highlight">Cell</span> Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental <span class="highlight">T</span> <span class="highlight">cell</span> therapy using a person's own modified white blood <span class="highlight">cells</span> with an experimental vaccine.

Who is this for?: People with stage IV (metastatic) breast cancer with a KRAS mutation who have received at least 2 lines of therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 days</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 days</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 1-4 days</li> <li class="seamTextUnorderedListItem"><span class="highlight">T</span> <span class="highlight">cells,</span> by IV, 1 time</li> <li class="seamTextUnorderedListItem">Vaccine, by injection, 3-4 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Many cancer <span class="highlight">cells</span> produce substances (antigens) that are unique to each cancer and stimulate the body's immune responses.</li> <li class="seamTextUnorderedListItem">Taking disease-fighting white blood <span class="highlight">cells</span> <span class="highlight">(T</span> <span class="highlight">cells)</span> from a person, changing those <span class="highlight">cells</span> so they will target the specific proteins (antigens) from the cancer <span class="highlight">cells,</span> and returning them to that person's blood is a form of gene therapy.</li> <li class="seamTextUnorderedListItem">A vaccine may help these modified white <span class="highlight">cells</span> work better.</li> <li class="seamTextUnorderedListItem">Leukapheresis is when blood is removed from the body, white blood <span class="highlight">cells</span> are separated, and the remaining blood is returned to the body.</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®) and cyclophosphamide (Cytoxan®) are chemotherapy drugs that make the <span class="highlight">T</span> <span class="highlight">cells</span> more effective in fighting cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">Aldesleukin is a drug that stimulates the growth and development of <span class="highlight">T</span> <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>
10

<span class="highlight">T</span> <span class="highlight">Cell</span> Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer
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Nearest Location:
2433 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Requires hospitalization for 3-4 weeks

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ClinicalTrials.gov: NCT06253520

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Phase I

11

Gene Therapy for KK-LC-1 Positive Metastatic Breast Cancer with a HLA Mutation

A Phase I Trial of <span class="highlight">T</span> <span class="highlight">Cell</span> Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Purpose: To study the safety and best dose of gene therapy with KK-LC-1 TCR <span class="highlight">T</span> <span class="highlight">cells,</span> an experimental immunotherapy.

Who is this for?: People with KK-LC-1 positive (KK-LC-1+) metastatic (stage IV) breast cancer with a HLA mutation that has progressed on standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis procedure</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, daily, 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, daily, 5 days</li> <li class="seamTextUnorderedListItem">KK-LC-1 TCR <span class="highlight">T</span> <span class="highlight">cells,</span> by injection, 1 session</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily, 4 days</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for 3-4 weeks</li> <li class="seamTextUnorderedListItem">May require follow-up visits every 3-6 months for up to 5 years</li> <li class="seamTextUnorderedListItem">May require questionnaires for up to 15 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts genetic material (DNA or RNA) directly into your <span class="highlight">cells</span> to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">Gene therapy with KK-LC-1 <span class="highlight">T</span> <span class="highlight">cell</span> receptor (TCR) <span class="highlight">T</span> <span class="highlight">cells</span> is an experimental type of immunotherapy that trains the immune system to attack KK-LC-1 positive cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">About 75% of triple negative breast cancer is KK-LC-1 positive.</li> <li class="seamTextUnorderedListItem">Leukapheresis is the removal of blood by a machine to collect specific immune <span class="highlight">cells</span> called <span class="highlight">T</span> <span class="highlight">cells</span> that will be modified to target cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">The <span class="highlight">T</span> <span class="highlight">cells</span> will be grown in a lab, modified, and given back to you through an injection into your tumor.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the <span class="highlight">T</span> <span class="highlight">cells</span> more effective in fighting cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the <span class="highlight">T</span> <span class="highlight">cells</span> live longer in your body.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05035407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/therapy/genetherapy/#:~:text=Gene%20therapy%20is%20a%20medical,of%20using%20drugs%20or%20surgery.' target='_blank'>MedlinePlus: What is Gene Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>National Cancer Institute: T Cell Transfer Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41598-018-24514-9' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>
11

Gene Therapy for KK-LC-1 Positive Metastatic Breast Cancer with a HLA Mutation

A Phase I Trial of <span class="highlight">T</span> <span class="highlight">Cell</span> Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers
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Nearest Location:
2433 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Requires hospitalization

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ClinicalTrials.gov: NCT05035407

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Phase I

12

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer

Purpose: To study the safety and effects (good and bad) of an immunotherapy that uses personalized <span class="highlight">T</span> <span class="highlight">cells.</span>

Who is this for?: People with metastatic (stage IV) breast cancer for which standard treatments have not worked. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be in the hospital and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Before hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of <span class="highlight">cells),</span> 2-4 months before receiving treatment</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay for receiving treatment (2-3 weeks):</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, once a day, for 2 days </li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara), by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Followed by Aldesleukin, by IV, once every 8 hours, for up to 4 days </li> <li class="seamTextUnorderedListItem">TCR-Transduced T-Cells, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">After hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic and antiviral, for at least 6 months</li> <li class="seamTextUnorderedListItem">Screening tests, every few months for the first year, every 6 months for the second year, then as determined</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To create the personalized <span class="highlight">T</span> <span class="highlight">cells,</span> cancer <span class="highlight">cells</span> will be taken from your tumor and white blood <span class="highlight">cells</span> will be removed from your blood. </li> <li class="seamTextUnorderedListItem">The cancer <span class="highlight">cells</span> will be analyzed to learn about the genetic mutations they contain. </li> <li class="seamTextUnorderedListItem">In a lab, your white blood <span class="highlight">cells</span> will be modified in ways that will help them go after your tumor <span class="highlight">cells.</span> </li> <li class="seamTextUnorderedListItem">They will then be infused into your body. This will take place in the hospital where the research study is taking place. </li> <li class="seamTextUnorderedListItem">When you receive the infused <span class="highlight">T</span> <span class="highlight">cells,</span> you will also be given Aldesleukin, an immune function enhancing drug. </li> <li class="seamTextUnorderedListItem">Your treatment will also include two chemotherapy drugs: cyclophosphamide (Cytoxan), which is used to treat breast cancer, and fludarabine (Fludara), which is approved to treat chronic lymphocytic leukemia (CLL). </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of metastatic cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03412877' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2014/ACTepithelial' target='_blank'>National Cancer Institute Press Release: Immunotherapy</a> </li></ul>
12

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer
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Nearest Location:
2433 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Hospital stay for up to 9 days; screening test every few months for 2 years

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ClinicalTrials.gov: NCT03412877

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Phase II

13

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers

Purpose: To study the safety and effects (good and bad) of using a new type of CAR T-cell immunotherapy.

Who is this for?: People with metastatic (stage IV) breast cancer that tests positive for CD70 who have already received at least one standard therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay (at least 1-week):</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of <span class="highlight">cells)</span></li> <li class="seamTextUnorderedListItem">Cyclophosphamide, by IV, once a day, for 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine, by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 3 times a day, for 3 days</li> <li class="seamTextUnorderedListItem">Anti-hCD70 CAR T-cells, by IV, one time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Post-hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic for 6 months</li> <li class="seamTextUnorderedListItem">Repeat Leukapheresis (blood draw for the collection of <span class="highlight">cells)</span></li> <li class="seamTextUnorderedListItem">1-2 day hospital visits (for lab tests, imaging studies, and a physical exam), every 1-3 months for the 1st year after treatment, every 6 months for the 2nd year, and then as determined by your doctor</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell is a personalized immunotherapy made from your white blood <span class="highlight">cells.</span> </li> <li class="seamTextUnorderedListItem">After your blood <span class="highlight">cells</span> are removed, they are modified with chimeric antigen receptors (CARs) so they can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study is designed to get the immune system to see and kill cancer <span class="highlight">cells</span> that are CD70+. </li> <li class="seamTextUnorderedListItem">Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph <span class="highlight">cells.</span> </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug that stimulates the growth and development of <span class="highlight">T</span> <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">Targets or mutations: CD70</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02830724' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr Susan Love Research Foundation: CAR-T Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/25368676' target='_blank'>Journal Article Abstract: CD70, A Potential Target in Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search?contains=false&q=Aldesleukin' target='_blank'>NCI Drug Dictionary: Aldesleukin</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>
13

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers
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Nearest Location:
2433 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Hospital stay for at least 1 week; follow-up visits for 2 years

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ClinicalTrials.gov: NCT02830724

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Phase I-II

14

TAA-T T-Cell Immunotherapy for Brain Metastasis

Phase I REsearch on Multi-antigen <span class="highlight">T</span> <span class="highlight">Cell</span> Infusion Against Neuro-oncologic Disease

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of TAA-T T-cell therapy, an experimental immunotherapy.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and have received standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy, by IV, 1-9 sessions every 4-6 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor multi-antigen associated specific cytotoxic <span class="highlight">T</span> lymphocytes (TAA-T) T-cell therapy is an experimental immunotherapy.</li> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy are tumor-specific immune <span class="highlight">cells</span> generated from your blood <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy may initiate an immune response against brain tumors and prevent tumor progression.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03652545' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
14

TAA-T T-Cell Immunotherapy for Brain Metastasis

Phase I REsearch on Multi-antigen <span class="highlight">T</span> <span class="highlight">Cell</span> Infusion Against Neuro-oncologic Disease
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Nearest Location:
2437 miles
Brain Tumor Institute, Children's National Medical Center
Washington, DC

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT03652545

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Phase I

15

CAR <span class="highlight">T</span> <span class="highlight">Cell</span> Therapy for Advanced Triple Negative, Mesothelin Expressing Breast Cancer

Phase 1, Adaptive-design Trial of Human Chimeric Antigen Receptor Modified <span class="highlight">T</span> <span class="highlight">Cells</span> in Patients With Mesothelin Expressing Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of huCART-meso <span class="highlight">cells,</span> an experimental CAR <span class="highlight">T</span> <span class="highlight">cell</span> therapy.

Who is this for?: People with advanced (stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that expresses mesothelin. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mesothelin expression testing on your tumor</li> <li class="seamTextUnorderedListItem">huCART-meso <span class="highlight">cells</span></li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">huCART-meso is an experimental immunotherapy called CAR <span class="highlight">T</span> <span class="highlight">cell</span> therapy.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR <span class="highlight">T</span> <span class="highlight">cell</span> therapy is a personalized immunotherapy made from your white blood <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">Your blood <span class="highlight">cells</span> are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR <span class="highlight">T</span> <span class="highlight">cells</span> are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">The CAR <span class="highlight">T</span> <span class="highlight">cell</span> therapy being used in this study trains the immune system to attack mesothelin expressing cancer <span class="highlight">cells.</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05623488' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>
15

CAR <span class="highlight">T</span> <span class="highlight">Cell</span> Therapy for Advanced Triple Negative, Mesothelin Expressing Breast Cancer

Phase 1, Adaptive-design Trial of Human Chimeric Antigen Receptor Modified <span class="highlight">T</span> <span class="highlight">Cells</span> in Patients With Mesothelin Expressing Breast Cancer
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Nearest Location:
2517 miles
University of Pennsylvania
Philadelphia, PA

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT05623488

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Phase I

16

KK-LC-1 TCR <span class="highlight">T</span> <span class="highlight">Cell</span> Therapy for Metastatic Triple Negative, KK-LC-1 Positive Breast Cancer with a HLA Mutation

<span class="highlight">T</span> <span class="highlight">Cell</span> Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of KK-LC-1 TCR <span class="highlight">T</span> <span class="highlight">cells,</span> an experimental immunotherapy.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-), KK-LC-1 positive (KK-LC-1+) breast cancer with a HLA mutation who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KK-LC-1 TCR <span class="highlight">T</span> <span class="highlight">cells,</span> by IV, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily for 1-2 days</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KK-LC-1 TCR <span class="highlight">T</span> <span class="highlight">cells</span> are an experimental immunotherapy that train the immune system to attack KK-LC-1 positive cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">The <span class="highlight">T</span> <span class="highlight">cells</span> will be grown in a lab, modified, and given back to you through an infusion.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the <span class="highlight">T</span> <span class="highlight">cells</span> more effective in fighting cancer <span class="highlight">cells.</li></span> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the <span class="highlight">T</span> <span class="highlight">cells</span> live longer in your body.</li> <li class="seamTextUnorderedListItem">KK-LC-1 is an abnormal protein that is expressed by certain types of cancer. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: KK-LC-1, HLA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05483491' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/treatments/immunotherapy/cellular-immunotherapy/tcr-therapy/' target='_blank'>Moffitt Cancer Center: T-Cell Receptor (TCR) Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>
16

KK-LC-1 TCR <span class="highlight">T</span> <span class="highlight">Cell</span> Therapy for Metastatic Triple Negative, KK-LC-1 Positive Breast Cancer with a HLA Mutation

<span class="highlight">T</span> <span class="highlight">Cell</span> Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers
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Nearest Location:
2548 miles
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT05483491

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Phase I

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