TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer

This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory breast cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this

Trial Details

NCT ID

NCT06532812

Phase

PHASE1 / PHASE2

Sponsor

Essen Biotech

Status

RECRUITING

Cancer Type

Triple Negative (TNBC) Breast Cancer

Interventions

Tumor Infiltrating Lymphocytes (TIL)
Cyclophosphamid
Fludarabine
Interleukin-2
Pembrolizumab

Locations (sample)

Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

Age: 16 years to 90 years
Histologically diagnosed as primary/relapsed/metastasized Breast Cancer
Expected life span more than 3 months
Karnofsky≥60% or ECOG score 0-2

For full eligibility, visit ClinicalTrials.gov.

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