A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Melanoma
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma. 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.
• Age: 18 years to 75 years;
• Histologically diagnosed as primary/relapsed/metastasized melanoma;
• Expected life-span more than 3 months;
• Karnofsky≥60% or ECOG score 0-2;
• Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
• Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
• At least 1 evaluable tumor lesion;
• 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/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;
• no absolute or relative contraindications to operation or biopsy;
⁃ Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion;
⁃ Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;
⁃ Be able to understand and sign the informed consent document;
⁃ Be able to stick to follow-up visit plan and other requirements in the agreement.