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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Affiliated Hospital of Xuzhou Medical University

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

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

The Affiliated Hospital of Xuzhou Medical University

Lead sponsor

Xuzhou Medical University

Collaborator

IIT MediTech Co. Ltd

Collaborator