HS-IT101 Injection in the Treatment of Advanced Solid Tumors
Trial Parameters
Brief Summary
Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.
Eligibility Criteria
Inclusion Criteria: * To be eligible for the study, patients must meet ALL of the following criteria prior to participation: 1. Age: 18 years to 75 years at the time of consent; 2. Histologically or cytological diagnosed as advanced soild tumor: 3. At least one resectable lesion that has not received radiotherapy or other local therapy within 28 days, and the weight of the tissue must be ≥ 0.050g；or resectable lesions capable of producing sufficient TIL; 4. At least one measurable target lesion, as defined by RECIST v1.1，that has not received radiotherapy or other local therapy unless these therapies occurred 28 days ago and target lesion shows significant progression; 5. ECOG score 0-1; 6. Expected life-span more than 3 months; 7. Adequate organ and bone marrow function: Absolute count of neutrophil ≥1.5×10\^9/L; Platelet count ≥90×10\^9/L; Hemoglobin ≥ 90g/L; AST, ALT≤2.5×ULN (subjects with liver metastasis ≤5×ULN); Totol bilirubin ≤1.5×ULN（Gilbert syndrome≤3×ULN）; Serum creatinine ≤