A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This phase Ib trial tests the safety, side effects and best dose of anti-HLA-A2/NY-ESO-1 T-cell receptor (TCR)-transduced autologous T lymphocytes (A2-ESO-1 TCR-T cells) in treating patients with NY-ESO-1 overexpression positive triple negative breast cancer (TNBC) that has come back after a period of improvement (relapsed/recurrent) or that does not respond to treatment (refractory), and that may have spread from where it first started (primary site) to nearby tissue, lymph nodes (advanced) or to other places in the body (metastatic). NY-ESO-1 is an antigen found on the surface of many different types of tumor cells including TNBC. Antigens make it possible for immune cells to recognize and kill germ cells that invade the body, however, it is more difficult for immune cells to recognize antigens on tumor cells. T cells are a special type of immune cell in the blood. These T cells may be trained to recognize the NY-ESO-1 antigen on tumor cells, allowing the T cells to attack and kill those tumor cells. The A2-ESO-1 TCR-T cells are T cells that have been removed from the patient's blood through a process called leukapheresis and then changed in the laboratory to recognize NY-ESO-1 on tumor cells. When given back to the patient, these A2-ESO-1 TCR-T cells find and attack tumor cells that express NY-ESO-1. Chemotherapy drugs, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. They are given before the T cells to support optimum activity of the A2-ESO-1 TCR-T cells. IL-2 (aldesleukin) is in a class of drugs known as cytokines. It is a man-made version of a naturally occurring protein that stimulates the body to produce other chemicals which increase the body's ability to fight cancer. A2-ESO-1 TCR-T cells may kill more tumor cells in patients with recurrent or refractory advanced or metastatic TNBC that overexpresses NY-ESO-1.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku 18 lat lub więcej
- •Potwierdzony rozległy lub przerzutowy rak piersi typu TNBC, który nawrócił lub nie reaguje na 2 lub więcej linii standardowego leczenia
- •Markery genetyczne HLA-A2+ i wysoki poziom białka NY-ESO-1 w komórkach nowotworowych
- •Mierzalne zmiany nowotworowe
- •Spodziewana długość życia co najmniej 6 miesięcy
- •Dobry stan ogólny (skala ECOG 0 lub 1)
- •Wystarczające liczby krwinek (hemoglobina ≥9.0, neutrofile ≥1500, płytki ≥100,000)
- •Prawidłowa funkcja nerek i wątroby
✗ Disqualifies
- •Chemioterapia lub radioterapia w ciągu ostatnich 2 tygodni
- •Podanie cyklofosfamidu w ciągu ostatnich 4 miesięcy
- •Poważne problemy sercowe lub historia zawału, udar lub zaburzenia rytmu serca w ostatnim roku
- •Przerzuty do mózgu lub opon mózgowych
- •Ciąża lub karmienie piersią
- •Nieprawidłowa długość odstępu QT lub inne zaburzenia elektryczne serca
- •Nietolerancja cyklofosfamidu, fludarabiny, IL-2 lub ich składników
- •Niekontrolowane infekcje, poważnie upośledzona funkcja płuc lub inne niestabilne warunki medyczne
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- May 19, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
USC / Norris Comprehensive Cancer Center
Los Angeles, United States
Trial contact
Kimberly Arieli, RN
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.