About this trial
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
Qualifiers
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.
Disqualifiers
The subject is a pregnant or lactating woman.
The subjects have infectious diseases (such as HIV, syphilis, active tuberculosis, etc.);
The subject has active infection or coagulation dysfunction.
Subjects with previous hepatic encephalopathy.
Trial design
Treatments tested in this trial
- fhB7H3.CAR-Ts
- Fludarabine
- Cyclophosphamide
Treatment groups
Sponsors and collaborators
The Affiliated Hospital of Xuzhou Medical University
Lead sponsor
Xuzhou Medical University
Collaborator
IIT MediTech Co. Ltd
Collaborator