TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer
Trial Parameters
Brief Summary
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 combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.
Eligibility Criteria
Inclusion 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 * Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available. * Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated * At least 1 evaluable tumor lesion * Hematology and Chemistry（within 7 days prior to enrollment）: * Absolute count of white blood cells≥2.5×10\^9/L * Absolute count of neutropils≥1.5×10\^9/L * Absolute count of lymphocytes ≥0.7×109/L * Platelet count≥100×10\^9 * hemoglobin≥90 g/L * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days) * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days) * Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L),