drugset / Trial / NCT05211557
Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer
Phase 1/2
Recruiting
15 enrolled
The Affiliated Hospital of Xuzhou Medical University
IIT MediTech (Jiangsu) Co. Ltd · collabXuzhou Medical University · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-11-16
- Primary completion
- 2023-08-31
- Completion
- 2026-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fhB7H3.CAR-Ts | Cell therapy | 500000 cells/kg | Intravenous |
| Subject | fhB7H3.CAR-Ts | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | fhB7H3.CAR-Ts | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | fhB7H3.CAR-Ts | Cell therapy | 5e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | — | — |