drugset / Trial / NCT04077866
B7-H3 CAR-T for Recurrent or Refractory Glioblastoma
Phase 1/2
Unknown
40 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
BoYuan RunSheng Pharma (Hangzhou) Co., Ltd. · collabHuizhou Municipal Central Hospital · collabNingbo Yinzhou People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, parallel-arm, phase I/II study to evaluate the safety and efficacy of B7-H3 CAR-T in between Temozolomide cycles comparing to Temozolomide alone in treating patients with glioblastoma that has come back or does not respond to the standard treatment. The antigen B7-H3 is highly expressed in glioblastoma of a subset of patients. B7-H3 CAR-T, made from isolated patient peripheral blood mononuclear cells, can specifically attack patient glioblastoma cells that expressing B7-H3.
Timeline
- Start
- 2023-06-01
- Primary completion
- 2025-06-01
- Completion
- 2025-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | B7-H3CART | Cell therapy | — | Other |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |