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Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer
Sponsor: The Affiliated Hospital of Xuzhou Medical University
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
Conditions
Interventions
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.
Fludarabine
30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3)
Cyclophosphamide
750 mg/m2 i.v. for once (Day -5)
Locations (1)
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China