OncoMatch/Clinical Trials/NCT05142475
A Study of GC101 TIL in Advanced Breast Cancer (10hospital)
Is NCT05142475 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Tumor Infiltrating Lymphocytes (TIL) for breast cancer.
Treatment: Tumor Infiltrating Lymphocytes (TIL) — This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy (GC 101 TIL) in patients with advanced breast cancer. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Prior therapy
Must have received: standard treatment regimens
Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
Cannot have received: any malignant tumor-targeting therapies (radiotherapy, chemotherapy, biologics)
Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs
Cannot have received: other medicines, or other biologic therapy, chemo-or radiotherapy
Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy
Cannot have received: immunotherapy
Having received immunotherapy and developed irAE level greater than Level 3
Lab requirements
Blood counts
Absolute count of white blood cells≥2.5×10^9/L; Absolute count of neutropils≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×10^9/L; Platelet count≥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)
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); Totol bilirubin≤1.5×ULN
Hematology and Chemistry（within 7 days prior to enrollment）: ... 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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