Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer

Prior treatment

• Subjects with previous hepatic encephalopathy.
• The subject is on anticoagulation or antiplatelet therapy.
• The subject is an organ transplant or waiting for transplant.
• The subject has received chemotherapy/radiotherapy within the past 4 weeks.
• The subject is receiving systemic hormone therapy.

Other illness

• The subjects have infectious diseases (such as HIV, syphilis, active tuberculosis, etc.);
• The subject has active infection or coagulation dysfunction.
• Subjects with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation.
• The subjects are highly allergic or have a history of severe allergies.
• The subject has a history of cellular immunotherapy or antibody therapy.
• Subjects with systemic infection or severe local infection requiring anti-infection treatment.
• The subject has dysfunction of important organs such as heart, lung, brain, liver, and kidney.

Other

• The subject is a pregnant or lactating woman.
• The subject is participating in other clinical research.
• The doctor believes that there are other reasons not to be included in the treatment.
• Unwilling or unable to provide consent/assent for participation in the study.

• Subjects should be 18-70 years old.
• Subject has adequate performance status as defined by ECOG score of≤ 2.
• Expected life expectancy is no less than 12 weeks.
• Subjects must have histologically or cytologically confirmed unresectable, recurrent and / or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measured positive for B7H3 expression.
• Child-Pugh A, B grade.
• Blood routine:
  • white blood cell count≥ 2.5 × 10\^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10\^9 / L; lymphocyte proportion≥ 15 %;
• 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%;
• No allergic reaction to contrast agents.
• Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production.
• Patients or their legal guardians voluntarily participate in and sign the informed consent form.