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RECRUITING
NCT05211557
PHASE1/PHASE2

Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer

Sponsor: The Affiliated Hospital of Xuzhou Medical University

View on ClinicalTrials.gov

Summary

This is single center, open-label phase I, non-randomized study which will enroll patients with recurrent advanced ovarian cancer to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T cells (fhB7H3.CAR-Ts) via using a '3+3+3' dose escalation design. In the dose expansion cohort, six patients will be enrolled to further assess their efficacy with the optimal dosage.

Official title: A Single-Arm, Open-Label Study to Evaluate Safety and Efficacy of Fully Human B7H3 CAR-T in Treating Patients With Recurrent Malignant Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2021-11-16

Completion Date

2026-08-31

Last Updated

2022-01-27

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

fhB7H3.CAR-Ts

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. Other Name: B7H3 targeting chimeric antigen receptor T cells Drug: Fludarabine 30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3) Other Name: FLUDARA Drug: Cyclophosphamide 750 mg/m2 i.v. for once (Day -5) Other Name: Cytoxan

Locations (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China