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RECRUITING
NCT05323201
PHASE1/PHASE2

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

Sponsor: The Affiliated Hospital of Xuzhou Medical University

View on ClinicalTrials.gov

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.

Official title: A Single-Arm, Open-Label Study to Evaluate Safety and Efficacy of B7H3 or HBsAg Targeting CAR-T in Treating Advanced Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2022-02-10

Completion Date

2027-02-10

Last Updated

2022-04-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

fhB7H3.CAR-Ts

fhB7H3.CAR-Ts will be transhepatic arterial infused after lymphodepletion. Three dose levels will be evaluated: Dose Level 1 (1×10\^6/kg), dose Level 2 (3×10\^6/kg) and dose Level 3 (5×10\^6/kg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\^6/kg /infusion) will be evaluated.

DRUG

Fludarabine

30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3)

DRUG

Cyclophosphamide

750 mg/m2 i.v. for once (Day -5)

Locations (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China