OncoMatch/Clinical Trials/NCT06532812
TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer
Is NCT06532812 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for breast cancer.
Treatment: Tumor Infiltrating Lymphocytes (TIL) · Cyclophosphamid · Fludarabine · Interleukin-2 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Performance status
KARNOFSKY/ECOG 0–2
Karnofsky≥60% or ECOG score 0-2
Prior therapy
Cannot have received: any malignant tumor-targeting therapy
Exception: must cease 28 days before obtaining TILs
Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs
Lab requirements
Blood counts
Absolute count of white blood cells ≥2.5×10^9/L; neutrophils ≥1.5×10^9/L; lymphocytes ≥0.7×10^9/L; platelets ≥100×10^9; hemoglobin ≥90 g/L
Kidney function
Serum creatinine ≤1.5mg/dL (or ≤132.6μmol/L), or clearance rate ≥50mL/min
Liver function
Serum ALT/AST ≤3×ULN (subjects with liver metastasis ≤3×ULN); Total bilirubin ≤1.5×ULN
Cardiac function
No significant cardiovascular anomalies (NYHA Grade III or IV CHF, low blood pressure, uncontrollable symptomatic coronary artery diseases, EF <35%, severe arrhythmia, second-third degree AV block)
Hematology and Chemistry（within 7 days prior to enrollment）: Absolute count of white blood cells≥2.5×10^9/L; neutrophils≥1.5×10^9/L; lymphocytes ≥0.7×10^9/L; platelets≥100×10^9; hemoglobin≥90 g/L; APTT ≤1.5xULN (unless received anticoagulant therapy within the previous 3 days); INR ≤1.5xULN (unless received anticoagulant therapy within the previous 3 days); Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min; Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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