Study of GC101 TIL in Brain Glioma (Soochow2)
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant glioma . Autologous TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide
| Condition(s) | Glioma |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant glioma . Autologous TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide. |
| Who can participate | Inclusion Criteria 1. Age: 18 years to 75 years; 2. Histologically diagnosed as primary/relapsed/metastasized brain glioma; 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 rece |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shanghai Juncell Therapeutics |
| Locations | Suzhou, Jiangsu, China |
| Start date | 2021-05-06 |
| NCT ID | NCT04943913 |
| Official listing | https://clinicaltrials.gov/study/NCT04943913 |