A2-ESO-1 TCR-Engineered T Cells for Triple Negative Breast Cancer
This study is testing the safety and best dose of a new treatment called Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes (A2-ESO-1 TCR-engineered T cells) for women with advanced or metastatic triple negative breast cancer (TNBC). This type of cancer has either come back after treatment (relapsed/recurrent) or isn't responding to current treatments (refractory). The treatment uses your own immune cells, modified to recognize and fight cancer cells that have a specific marker called NY-ESO-1. Researchers will also give Aldesleukin, another medicine, and perform biopsies and CT scans. The main goal is to find the highest safe dose of the A2-ESO-1 TCR-engineered T cells. This study is currently recruiting about 20 participants.
- Study design
- This is a dose-escalation study, meaning participants will receive increasing doses of the treatment to find the safest and most effective amount. It is a Phase 1b study and plans to enroll about 20 participants.
- What's involved
- You would undergo procedures like a breast tumor biopsy, blood sample collections, and CT scans. The study will also involve receiving Aldesleukin and Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes intravenously.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main safety measures will be checked for up to 6 weeks after receiving the A2-ESO-1 TCR-engineered T cell infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05989828
A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Southern CaliforniaInvestigator-initiated
~20 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:AldesleukinAnti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T LymphocytesBiopsyBiospecimen CollectionComputed TomographyCyclophosphamide
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of anti-HLA-A2/NY-ESO-1 T-cell receptor (TCR)-transduced autologous T lymphocytes (A2-ESO-1 TCR-engineered T cells)
Measured over Up to 6 weeks after A2-ESO-1 TCR-engineered T cell infusion
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Daphne Stewart, MD · PRINCIPAL_INVESTIGATOR · University of Southern California
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Female aged \>= 18 years
Histologically confirmed advanced or metastatic TNBC that have relapsed on or are refractory to 2 or more lines of standard-of-care therapy. TNBC is defined as estrogen receptor (ER) and progesterone receptor negative (\< 10% immunohistochemistry \[IHC\] staining) and HER2 negative (IHC 1+ or 0 AND/OR in situ hybridization negative based on:
Single-probe average HER2 copy number \< 4.0 signals/cell
Dual-probe HER2/CEP17 ratio \< 2.0 with an average HER2 copy number \< 4.0 signals/cell)
HLA-A2+ and tumoral overexpression of NY-ESO-1 (2 to 3+ IHC staining in \> 50% of cells)
Have measurable disease based on RECIST 1.1
Life expectancy \>= 6 months
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Hemoglobin \>= 9.0 g/dL (transfusions permitted)
Absolute neutrophil count (ANC) \>= 1500/mm\^3
Platelet count \>= 100,000/mm\^3
Creatinine (Cr) \< 2 x upper limit of normal (ULN), and Cr clearance (CrCl) \>= 50 mL/min by Cockcroft and Gault
Alanine transaminase (ALT) and aspartate transaminase (AST) \< 2 x ULN (Patients with liver metastases whose ALT/AST are \< 5 x ULN are eligible for enrollment)
Bilirubin \< 2 x ULN
Lymphocyte count \>= 500/uL
Cardiac left ventricular ejection fraction (LVEF) \>= 50%
Negative serum pregnancy (human chorionic gonadotropin \[beta-hCG\]) test within 7 days of leukapheresis for women of childbearing potential (WOCBP). WOCBP must be willing to use a highly effective method of contraception for the course of the study through 90 days after A2-ESO-1 TCR-engineered T cell infusion
Willing and able to provide written informed consent for the study
Willing to provide biopsy tissues and blood samples as required by the study
Exclusion
Radiation therapy, chemotherapy, or non-cytotoxic investigational agent within 2 weeks of leukapheresis
Received cyclophosphamide within the past 4 months
Evidence of New York Heart Association class III or greater cardiac disease
History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within the past 12 months
History of congenital QT prolongation
Absolute QT interval of \> 470 msec in the presence of \> 4.0 mEq/L potassium and \> 1.8 mg/dL magnesium
Brain or leptomeningeal metastases
Females who are pregnant or breastfeeding
Hypersensitivity or intolerance to cyclophosphamide, fludarabine, IL-2, or their components
History of clinically significant gastrointestinal bleeding, gastric or intestinal ulceration, or perforation within 6 months of enrollment.
Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study, such as severely impaired lung function, any active (acute or chronic) or uncontrolled infection/disorders, and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study treatment
Current use of medications that interact with or compromise the immune system such as steroid doses \> 10 mg/day prednisone or equivalent daily within 2 weeks before leukapheresis
History of immunodeficiency disease or autoimmune disease, with exceptions such as Hashimoto's thyroiditis / hypothyroidism, or controlled Type 1 diabetes
Have any active and uncontrolled infection.
Active hepatitis B (as defined as positive hepBsAntigen or detectable hepatitis B DNA) or hepatitis C infection. Patients who are hepatitis B surface Antigen negative and have a negative hep B DNA are allowed. If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. Patients with laboratory evidence of cleared hepatitis B or C infection may enroll. Patients with no prior history of hepatitis B infection who have been vaccinated against hepatitis B and who have a positive antibody against hepatitis B surface antigen as the only evidence of prior exposure may enroll. Patients with a history of hepatitis C infection may be eligible if they have completed antiviral treatment and show no detectable HCV RNA for 6 months prior to enrollment.
Human immunodeficiency virus (HIV) infection or seropositive for HIV antigens
Concurrent use of any complementary or alternative medicines
Unwilling or unable to comply with the study protocol
Prior major surgery that requires general anesthesia must be completed at least 4 weeks before leukapheresis and surgery that requires local anesthesia (except for study tissue sample collection) must be completed at least 2 weeks before leukapheresis and surgery that requires local anesthesia (except for study tissue sample collection) must be completed at least 2 weeks before leukapheresis
What this trial measures
- Maximum tolerated dose (MTD) of anti-HLA-A2/NY-ESO-1 T-cell receptor (TCR)-transduced autologous T lymphocytes (A2-ESO-1 TCR-engineered T cells)Up to 6 weeks after A2-ESO-1 TCR-engineered T cell infusion
Will employ the Bayesian optimal interval to find the MTD.
- Incidence of dose-limiting toxicitiesUp to 6 weeks after A2 ESO-1 TCR-engineered T cell infusion
Defined as any treatment-related death or any greater than or equal to grade 3 adverse event (AE) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.