Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer
Trial Parameters
Brief Summary
This is single center, open-label phase I/II, non-randomized study which will enroll patients with recurrent advanced hepatocellular carcinoma to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T in treating hepatocellular carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Subjects should be 18-70 years old. 2. Subject has adequate performance status as defined by ECOG score of≤ 2. 3. Expected life expectancy is no less than 12 weeks. 4. Subjects must have histologically or cytologically confirmed unresectable, recurrent and / or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measured positive for B7H3 expression. 5. Child-Pugh A, B grade. 6. Blood routine: white blood cell count≥ 2.5 × 10\^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10\^9 / L; lymphocyte proportion≥ 15 %; 7. Adequate organ function. Patients' main organs ( heart, lung, liver, kidney, etc. ) function well: ALT and AST≤ 5 × ULN; ALB≥ 30 g/L； Total bilirubin≤ 2.5 × ULN； Serum creatinine\< 220μmol/L; Indoor oxygen saturation ≥ 95 %; Left ventricular ejection fraction≥ 40%; 8. No allergic reaction to contrast agents. 9. Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells ca