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1

P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid <span class="highlight">Tumors</span>

Purpose: <span class="highlight">To</span> study <span class="highlight">the</span> safety, best dose, effects (good and bad), and anti-cancer activity of P-MUC1C-ALLO1, an experimental CAR-T cell immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer <span class="highlight">that</span> has progressed on standard <span class="highlight">treatment.</span> View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned <span class="highlight">to</span> 1 of 2 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, 1 session</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, multiple sessions</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) may be given for safety</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 is an experimental immunotherapy called CAR-T cell <span class="highlight">therapy.</li></span> <li class="seamTextUnorderedListItem">Allogeneic CAR-T cell <span class="highlight">therapy</span> is an immunotherapy made from donor immune cells.</li> <li class="seamTextUnorderedListItem">Donor immune cells are modified with chimeric antigen receptors (CARs) so <span class="highlight">they</span> can attack cancer cells.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T-cells</span> are <span class="highlight">then</span> infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) is an enzyme <span class="highlight">that</span> can be administered for safety <span class="highlight">to</span> kill CAR-T cells, if needed.</li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is also enrolling people with other <span class="highlight">types</span> 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/NCT05239143' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://poseida.com/science/pipeline/#cart-therapies' target='_blank'>Poseida Therapeutics Drug Information Page: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/poseida-therapeutics-announces-fda-clearance-of-investigational-new-drug-application-for-p-muc1c-allo1-a-fully-allogeneic-car-t-targeting-multiple-solid-tumors-301447910.html' target='_blank'>Poseida Therapeutics Press Release: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bellicum.com/caspacide-safety-switch/' target='_blank'>Bellicum Phamaceuticals Drug Information Page: Rimiducid (CaspaCIDe®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fimmu.2020.618427/full' target='_blank'>Journal Article: Allogeneic CAR T-Cell Immunotherapy</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>
1

P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid <span class="highlight">Tumors</span>
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Nearest Location:
5 miles
University of California, San Francisco
San Francisco, CA

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT05239143

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Phase I

2

LYL797 <span class="highlight">CAR</span> <span class="highlight">T-Cell</span> Immunotherapy for <span class="highlight">Triple</span> Negative, ROR1 Positive Advanced Breast Cancer

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

Purpose: <span class="highlight">To</span> study <span class="highlight">the</span> safety, best dose, effects (good and bad), and anti-cancer activity of LYL797, an experimental <span class="highlight">type</span> of immunotherapy called <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy.</span>

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

What's involved?

<p class="seamTextPara"> You will receive <span class="highlight">the</span> following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy</span></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 <span class="highlight">treatment</span> schedule. Hospital stay may be required.</i></p>

What's being studied?

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

A Phase 1 Study <span class="highlight">to</span> Assess <span class="highlight">the</span> Safety and Efficacy of LYL797, ROR1-Targeting <span class="highlight">CAR</span> <span class="highlight">T</span> Cells, 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

<span class="highlight">CAR</span> <span class="highlight">T-Cell</span> Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases

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

Purpose: <span class="highlight">To</span> study <span class="highlight">the</span> safety, best dose, and effects (good and bad) of a <span class="highlight">CAR</span> <span class="highlight">T-cell</span> immunotherapy <span class="highlight">that</span> is delivered directly into <span class="highlight">the</span> 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 <span class="highlight">the</span> following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw <span class="highlight">to</span> collect white blood cells <span class="highlight">to</span> make your HER2 <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy</span> (leukapheresis)</li> <li class="seamTextUnorderedListItem">Surgery <span class="highlight">to</span> place a device (similar <span class="highlight">to</span> a chemotherapy port) under your scalp</li> <li class="seamTextUnorderedListItem">HER2 <span class="highlight">CAR</span> <span class="highlight">T-cells,</span> by injection, weekly, 3 <span class="highlight">times</span></li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> 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, <span class="highlight">then</span> every year for 15 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads <span class="highlight">to</span> <span class="highlight">the</span> membranes surrounding <span class="highlight">the</span> brain and/or <span class="highlight">the</span> spinal cord (leptomeninges) or <span class="highlight">to</span> <span class="highlight">the</span> cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">CAR-T or <span class="highlight">CAR</span> <span class="highlight">T</span> cell <span class="highlight">therapy</span> is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so <span class="highlight">that</span> <span class="highlight">they</span> can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T-cells</span> are <span class="highlight">then</span> infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy</span> being used in <span class="highlight">this</span> study <span class="highlight">trains</span> <span class="highlight">the</span> immune system <span class="highlight">to</span> attack HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">You will have surgery <span class="highlight">to</span> insert a device under your scalp so <span class="highlight">that</span> <span class="highlight">the</span> <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy</span> 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>
3

<span class="highlight">CAR</span> <span class="highlight">T-Cell</span> Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases

A Phase 1 Cellular Immunotherapy Study of Intraventricularly Administered Autologous HER2-Targeted Chimeric Antigen Receptor (HER2-CAR) <span class="highlight">T</span> Cells 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

4

<span class="highlight">CAR</span> <span class="highlight">T-Cell</span> Immunotherapy for Metastatic Breast Cancer <span class="highlight">That</span> <span class="highlight">Tests</span> Positive for MUC 1*

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

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

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

What's involved?

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

What's being studied?

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

<span class="highlight">CAR</span> <span class="highlight">T-Cell</span> Immunotherapy for Metastatic Breast Cancer <span class="highlight">That</span> <span class="highlight">Tests</span> Positive for MUC 1*

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous <span class="highlight">T</span> Cells Engineered <span class="highlight">to</span> 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 & Immunotherapy Injected Directly into <span class="highlight">Tumors</span> for Metastatic HER2 Positive Breast Cancer

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

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

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 <span class="highlight">the</span> following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAdVEC, by injection directly into a <span class="highlight">tumor,</span> one <span class="highlight">time</span></li> </ul> <p class="seamTextPara"> followed by </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2-specific CAR-T Cell <span class="highlight">therapy,</span> by IV, one <span class="highlight">time</span></li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> 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 cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) <span class="highlight">that</span> allow <span class="highlight">them</span> <span class="highlight">to</span> attack proteins on cancer cells, and <span class="highlight">then</span> put back in your body.</li> <li class="seamTextUnorderedListItem">CAdVEC is an oncolytic adenovirus--this means it <span class="highlight">targets</span> and kills cancer cells. It may directly kill cancer cells and stimulate your immune system <span class="highlight">to</span> go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">CAdVEC is injected directly into a <span class="highlight">tumor.</span> </li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is also enrolling people with other <span class="highlight">types</span> 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>
5

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

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

6

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

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

Purpose: <span class="highlight">To</span> study <span class="highlight">the</span> safety, best dose, effects (good and bad), and anti-cancer activity of PRGN-3007 <span class="highlight">CAR</span> <span class="highlight">T-cells,</span> an experimental immunotherapy.

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

What's involved?

<p class="seamTextPara"> You will receive <span class="highlight">the</span> 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 <span class="highlight">CAR</span> <span class="highlight">T-cells</span></li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR-T or <span class="highlight">CAR</span> <span class="highlight">T</span> cells are an experimental personalized immunotherapy made from your white blood cells. <span class="highlight">The</span> white blood cells are removed from your body and <span class="highlight">then</span> modified with chimeric antigen receptors (CARs) so <span class="highlight">they</span> can attack specific proteins. <span class="highlight">These</span> white blood cells are <span class="highlight">then</span> infused into your body.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy</span> used in <span class="highlight">this</span> study <span class="highlight">trains</span> <span class="highlight">the</span> immune system <span class="highlight">to</span> attack cancer cells <span class="highlight">that</span> <span class="highlight">test</span> positive for <span class="highlight">the</span> protein ROR-1.</li> <li class="seamTextUnorderedListItem">Before you receive PRGN-3007 <span class="highlight">T-cells,</span> you will be given <span class="highlight">the</span> chemotherapy drug cyclophosphamide (Cytoxan®) <span class="highlight">to</span> prepare your immune system <span class="highlight">to</span> receive <span class="highlight">the</span> immunotherapy.</li> <li class="seamTextUnorderedListItem">Leukapheresis is a procedure <span class="highlight">to</span> collect your white blood cells <span class="highlight">to</span> make your personalized <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy.</li></span> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is also enrolling people with other <span class="highlight">types</span> 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>
6

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

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

7

<span class="highlight">CAR</span> <span class="highlight">T-Cell</span> Immunotherapy for Metastatic Breast Cancer <span class="highlight">That</span> <span class="highlight">Tests</span> Positive for CD70

A Phase I/II Study Administering Peripheral Blood Lymphocytes <span class="highlight">Transduced</span> With a CD70-Binding Chimeric Antigen Receptor <span class="highlight">to</span> Patients With CD70 Expressing Cancers

Purpose: <span class="highlight">To</span> study <span class="highlight">the</span> safety and effects (good and bad) of using a new <span class="highlight">type</span> of <span class="highlight">CAR</span> <span class="highlight">T-cell</span> immunotherapy.

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

What's involved?

<p class="seamTextPara"> You will receive <span class="highlight">the</span> 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 <span class="highlight">the</span> collection of cells)</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 <span class="highlight">times</span> a day, for 3 days</li> <li class="seamTextUnorderedListItem">Anti-hCD70 <span class="highlight">CAR</span> <span class="highlight">T-cells,</span> by IV, one <span class="highlight">time</span></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 <span class="highlight">the</span> collection of cells)</li> <li class="seamTextUnorderedListItem">1-2 day hospital visits (for lab <span class="highlight">tests,</span> imaging studies, and a physical exam), every 1-3 months for <span class="highlight">the</span> 1st year after <span class="highlight">treatment,</span> every 6 months for <span class="highlight">the</span> 2nd year, and <span class="highlight">then</span> as determined by your doctor</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR <span class="highlight">T-cell</span> is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">After your blood cells are removed, <span class="highlight">they</span> are modified with chimeric antigen receptors (CARs) so <span class="highlight">they</span> can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T-cells</span> are <span class="highlight">then</span> infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy</span> used in <span class="highlight">this</span> study is designed <span class="highlight">to</span> get <span class="highlight">the</span> immune system <span class="highlight">to</span> see and kill cancer cells <span class="highlight">that</span> are CD70+. </li> <li class="seamTextUnorderedListItem">Along with <span class="highlight">the</span> CAR-T immunotherapy, you will receive <span class="highlight">the</span> chemotherapy drugs fludarabine and cyclophosphamide. <span class="highlight">These</span> drugs are given <span class="highlight">to</span> deplete <span class="highlight">the</span> lymph cells. </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug <span class="highlight">that</span> stimulates <span class="highlight">the</span> growth and development of <span class="highlight">T</span> cells.</li> <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>
7

<span class="highlight">CAR</span> <span class="highlight">T-Cell</span> Immunotherapy for Metastatic Breast Cancer <span class="highlight">That</span> <span class="highlight">Tests</span> Positive for CD70

A Phase I/II Study Administering Peripheral Blood Lymphocytes <span class="highlight">Transduced</span> With a CD70-Binding Chimeric Antigen Receptor <span class="highlight">to</span> 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

8

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

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

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

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

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">huCART-meso is an experimental immunotherapy called <span class="highlight">CAR</span> <span class="highlight">T</span> cell <span class="highlight">therapy.</li></span> <li class="seamTextUnorderedListItem">CAR-T or <span class="highlight">CAR</span> <span class="highlight">T</span> cell <span class="highlight">therapy</span> is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so <span class="highlight">that</span> <span class="highlight">they</span> can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T</span> cells are <span class="highlight">then</span> infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T</span> cell <span class="highlight">therapy</span> being used in <span class="highlight">this</span> study <span class="highlight">trains</span> <span class="highlight">the</span> immune system <span class="highlight">to</span> attack mesothelin expressing cancer cells.</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/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>
8

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

Phase 1, Adaptive-design <span class="highlight">Trial</span> of Human Chimeric Antigen Receptor Modified <span class="highlight">T</span> Cells 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

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