NCT06828328 A Study of GC203 TIL in PDCA (RJ)
| NCT ID | NCT06828328 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai Juncell Therapeutics |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2028-01-31 |
Trial Parameters
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Brief Summary
This study is to investigate the safety and efficacy of gene-edited tumor infiltrating lymphocyte (GC203 TIL) therapy in patients with pancreatic ductal adenocarcinoma. Gene-edited 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. have done the tumor resection for gene-edited GC203 TIL production and successfully produced； 2. Age: 18 years to 70 years; 3. Histologically diagnosed as pancreatic ductal adenocarcinoma; 4. Expected life-span more than 3 months; 5. ECOG score 0-1; 6. Test subjects have failed standard treatment regimens, and be willing to recieve gene-edited GC203 TIL therapy; 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≥90×10\^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), or clearance rate≥50mL/min; Serum ALT/AST ≤3×ULN(sub
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