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

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 differ

Trial Details

NCT ID
NCT05989828
Phase
PHASE1
Sponsor
University of Southern California
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Aldesleukin
  • Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes
  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Cyclophosphamide
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • 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 i…
  • 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)

For full eligibility, visit ClinicalTrials.gov.

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