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1

Studying HLA Gene Changes and Storing Immune Cells for Future Immunotherapy for Advanced <span class="highlight">Triple</span> Negative Breast Cancer

An Observational Study Obtaining Solid <span class="highlight">Tumor</span> <span class="highlight">Tissue</span> from Participants and Apheresis for <span class="highlight">CAR</span> <span class="highlight">T-Cell</span> <span class="highlight">Therapy</span> Manufacturing (BASECAMP-1)

Purpose: <span class="highlight">To</span> study if <span class="highlight">tumors</span> have HLA gene changes and <span class="highlight">to</span> store immune cells <span class="highlight">that</span> will be used <span class="highlight">to</span> create a future immunotherapy <span class="highlight">treatment.</span>

Who is this for?: People with some stage III (advanced) or stage IV (metastatic) <span class="highlight">triple</span> negative (ER-, PR-, 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">Blood or saliva (spit) sample for HLA gene <span class="highlight">testing</span></li> <li class="seamTextUnorderedListItem">Apheresis</li> <li class="seamTextUnorderedListItem"><span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy</span> if <span class="highlight">the</span> cancer comes back</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">One reason <span class="highlight">tumors</span> may grow is because of changes in <span class="highlight">the</span> HLA gene.</li> <li class="seamTextUnorderedListItem">When HLA is mutated (changed), your immune system loses <span class="highlight">the</span> ability <span class="highlight">to</span> recognize <span class="highlight">the</span> cancer.</li> <li class="seamTextUnorderedListItem">Apheresis is a <span class="highlight">type</span> of blood draw <span class="highlight">that</span> collects white blood cells.</li> <li class="seamTextUnorderedListItem">CAR-T cell <span class="highlight">therapy</span> is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your cells will be stored <span class="highlight">to</span> create a <span class="highlight">CAR</span> <span class="highlight">T-cell</span> <span class="highlight">therapy</span> if your cancer returns.</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/NCT04981119' target='_blank'>ClinicalTrials.gov</a> </li></ul>
1

Studying HLA Gene Changes and Storing Immune Cells for Future Immunotherapy for Advanced <span class="highlight">Triple</span> Negative Breast Cancer

An Observational Study Obtaining Solid <span class="highlight">Tumor</span> <span class="highlight">Tissue</span> from Participants and Apheresis for <span class="highlight">CAR</span> <span class="highlight">T-Cell</span> <span class="highlight">Therapy</span> Manufacturing (BASECAMP-1)
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Nearest Location:
30 miles
Stanford University
Palo Alto, CA

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Visits:
At least 2 visits in 1 week

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ClinicalTrials.gov: NCT04981119

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Phase NA

2

A2B395 <span class="highlight">CAR</span> <span class="highlight">T</span> Cell <span class="highlight">Therapy</span> for Advanced Breast Cancer <span class="highlight">That</span> Expresses EGFR and Has Lost HLA Expression

A Seamless Phase 1/2 Study <span class="highlight">to</span> Evaluate <span class="highlight">the</span> Safety and Efficacy of A2B395, an Allogeneic Logic-gated <span class="highlight">Tmod™</span> <span class="highlight">CAR</span> <span class="highlight">T,</span> in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid <span class="highlight">Tumors</span> <span class="highlight">That</span> Express EGFR and Have Lost HLA-A*02 Expression (DENALI-1 (after BASECAMP-1))

Purpose: <span class="highlight">To</span> study <span class="highlight">the</span> safety, best dose, and effects (good and bad), and anti-cancer activity of A2B395, an experimental <span class="highlight">CAR</span> <span class="highlight">T</span> cell immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) <span class="highlight">triple</span> negative (ER-, PR-, HER2-) breast cancer <span class="highlight">that</span> expresses EGFR (EGFR+) and has lost HLA-A*02 expression. 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">A2B395</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To participate in <span class="highlight">this</span> study, your <span class="highlight">tumor</span> will be <span class="highlight">tested</span> for EGFR and HLA by also enrolling into <span class="highlight">the</span> BASECAMP-1 <span class="highlight">trial</span> (NCT04981119).</li> <li class="seamTextUnorderedListItem">HLA-A*02 is a marker found on cancer cells <span class="highlight">that</span> plays a role in how <span class="highlight">the</span> immune system responds <span class="highlight">to</span> cancer.</li> <li class="seamTextUnorderedListItem">EGFR (epidermal growth factor receptor) is a protein <span class="highlight">that</span> is involved in cell growth and survival. </li> <li class="seamTextUnorderedListItem">A2B395 is an experimental <span class="highlight">CAR</span> <span class="highlight">T</span> cell immunotherapy.</li> <li class="seamTextUnorderedListItem">CAR <span class="highlight">T</span> cell or CAR-T cell <span class="highlight">therapy</span> is an immunotherapy made from white blood cells.</li> <li class="seamTextUnorderedListItem">The 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 on 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 into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">In <span class="highlight">this</span> <span class="highlight">trial,</span> <span class="highlight">the</span> cells will attack cancer cells <span class="highlight">that</span> express EGFR and have lost HLA-A*02 expression. Normal healthy cells will not be <span class="highlight">targeted.</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></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/NCT06682793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy-mbc-2-2/' target='_blank'>Metastatic Trial Talk: Cell-Based Therapies: A Type of Immunotherapy for MBC</a> </li></ul>
2

A2B395 <span class="highlight">CAR</span> <span class="highlight">T</span> Cell <span class="highlight">Therapy</span> for Advanced Breast Cancer <span class="highlight">That</span> Expresses EGFR and Has Lost HLA Expression

A Seamless Phase 1/2 Study <span class="highlight">to</span> Evaluate <span class="highlight">the</span> Safety and Efficacy of A2B395, an Allogeneic Logic-gated <span class="highlight">Tmod™</span> <span class="highlight">CAR</span> <span class="highlight">T,</span> in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid <span class="highlight">Tumors</span> <span class="highlight">That</span> Express EGFR and Have Lost HLA-A*02 Expression (DENALI-1 (after BASECAMP-1))
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Nearest Location:
341 miles
UCLA Medical Center
Los Angeles, CA

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT06682793

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Phase I-II

3

<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>
3

<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

4

FT836 With or Without Chemotherapy and/or <span class="highlight">Targeted</span> <span class="highlight">Therapy</span> for Metastatic Breast Cancer

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf <span class="highlight">CAR</span> <span class="highlight">T-Cell</span> <span class="highlight">Therapy,</span> With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid <span class="highlight">Tumors</span>

Purpose: <span class="highlight">To</span> study <span class="highlight">the</span> safety, effects (good and bad), and anti-cancer activity of FT836 cell <span class="highlight">therapy</span> alone or with chemotherapy or <span class="highlight">targeted</span> <span class="highlight">therapy.</span>

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

What's involved?

<p class="seamTextPara"> You will be assigned <span class="highlight">to</span> 1 of 6 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 <span class="highlight">times</span></li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Cetuximab (Erbitux®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 <span class="highlight">times</span></li> <li class="seamTextUnorderedListItem">Cetuximab (Erbitux®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 <span class="highlight">times</span></li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836 is a <span class="highlight">type</span> of cell <span class="highlight">therapy</span> designed <span class="highlight">to</span> kill cancer cells.</li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is 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/NCT07216105' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fatetherapeutics.com/pipeline/immuno-oncology-candidates/ft836/' target='_blank'>Fate Therapeutics: FT836</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy-mbc-2-2/' target='_blank'>Metastatic Trial Talk: Cell-Based Therapy</a> </li></ul>
4

FT836 With or Without Chemotherapy and/or <span class="highlight">Targeted</span> <span class="highlight">Therapy</span> for Metastatic Breast Cancer

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf <span class="highlight">CAR</span> <span class="highlight">T-Cell</span> <span class="highlight">Therapy,</span> With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid <span class="highlight">Tumors</span>
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Nearest Location:
1583 miles
University of Minnesota Masonic Cancer Center
Minneapolis, MN

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07216105

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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

CAR-T Cells for Advanced <span class="highlight">Triple</span> Negative Breast Cancer

Study of Administration of <span class="highlight">T</span> Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing <span class="highlight">the</span> Inducible Caspase 9 Safety Switch in Subjects With <span class="highlight">Triple</span> Negative 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 an experimental CAR-T cell <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- or ER low, PR- or PR low, HER2- or HER2 low) 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> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR-T cell <span class="highlight">therapy,</span> by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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 B7-H3 expressing cancer cells.</li> <li class="seamTextUnorderedListItem">HER2 low is defined as IHC 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/NCT06347068' 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>
6

CAR-T Cells for Advanced <span class="highlight">Triple</span> Negative Breast Cancer

Study of Administration of <span class="highlight">T</span> Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing <span class="highlight">the</span> Inducible Caspase 9 Safety Switch in Subjects With <span class="highlight">Triple</span> Negative Breast Cancer
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Nearest Location:
2407 miles
University of North Carolina
Chapel Hill, NC

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT06347068

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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>
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<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

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