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Study identifier: NCT05989828 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer

Condition: Triple Negative Breast Cancer  ·  Sponsor: University of Southern California

PhasePhase 1
Planned participants20
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 divi…

This description comes directly from the study's public registry record.

Talk to the study team

Kimberly Arieli, RN  ·  323-865-3935  ·  Kimberly.Arieli@med.usc.edu

Always discuss trial participation with your own doctor first.

Locations (1)

USC / Norris Comprehensive Cancer CenterLos Angeles, California, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05989828