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1

TCR T Cell Therapy for Women with Advanced Triple Negative, HLA-A2+ Breast Cancer That Overexpresses NY-ESO-1

Phase Ib Clinical Trial of Autologous Anti-NY-ESO-1 TCR-Engineered T Cells in Patients With Relapsed/Refractory Locally Advanced or Metastatic NY-ESO-1-Expressing Triple Negative Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of an experimental T cell immunotherapy using a person's own modified immune cells.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low), HLA-A2 positive (HLA-A2+) breast cancer that overexpresses NY-ESO-1 who have received 2-3 lines of therapy for advanced disease. 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 1 month later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 times</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TCR T cell therapy, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Aldesleukin (Proleukin®), by IV, 3 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NY-ESO-1 is a protein found on the surface of many different types of tumor cells including triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Leukapheresis is the removal of blood by a machine to collect immune cells that will be modified to target cancer cells.</li> <li class="seamTextUnorderedListItem">Immune cells obtained with leukapheresis can be trained to recognize NY-ESO-1 on tumor cells, allowing the immune cells to attack and kill those tumor cells.</li> <li class="seamTextUnorderedListItem">In this study, immune cells are removed from your blood, taught how to recognize and kill tumor cells, and then injected back into your body. This is a type of T cell receptor (TCR) immunotherapy.</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 T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (Proleukin®) stimulates the body to produce other chemicals that increase the body's ability to fight cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</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/NCT05989828' 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>
1

TCR T Cell Therapy for Women with Advanced Triple Negative, HLA-A2+ Breast Cancer That Overexpresses NY-ESO-1

Phase Ib Clinical Trial of Autologous Anti-NY-ESO-1 TCR-Engineered T Cells in Patients With Relapsed/Refractory Locally Advanced or Metastatic NY-ESO-1-Expressing Triple Negative Breast Cancer
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Nearest Location:
348 miles
USC / Norris Comprehensive Cancer Center
Los Angeles, CA

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT05989828

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Phase I

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