NCT05087745 A Clinical Study on TIL for the Treatment of Advanced Solid Tumors
| NCT ID | NCT05087745 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai Juncell Therapeutics |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-12-10 |
| Primary Completion | 2024-12-10 |
Trial Parameters
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Brief Summary
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. 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.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18 years to 75 years; 2. Histologically diagnosed as primary/relapsed/metastasized solid tumors ; 3. Expected life-span more than 3 months; 4. Karnofsky≥60% or ECOG score 0-2; 5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available. 6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated; 7. At least 1 evaluable tumor lesion; 8. 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/