A Clinical Trial of P134 Cells in Recurrent Glioblastoma
Summary
This is an open-label, single-arm, dose-escalation and expansion Phase 1/2 clinical trial designed to evaluate the safety, tolerability and efficacy of P134 cells in patients with recurrent glioblastoma, to explore the maximum tolerated dose (MTD)and recommended Phase 2 dose (RP2D), and to characterize the cytokinetic profile of CAR-T cells in the cerebrospinal fluid of patients. Eligible participants are adults diagnosed with recurrent or progressive glioblastoma who are confirmed as grade 4 glioblastoma (IDH wild-type) by histopathology or molecular pathology. P134 cells are CD44/CD133 dual-targeting CAR-T cells developed by the research team led by Academician Jiang Tao and Professor Zhang Wei from the Beijing Neurosurgical Institute and the Department of Neurosurgery, Beijing Tiantan Hospital. This study is spearheaded by Professor Zhang Wei of the Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, China, with scientific oversight and guidance provided by Academician Jiang Tao of the Chinese Academy of Engineering.
Timeline
- Start
- 2026-01-05
- Primary completion
- 2028-02-29
- Completion
- 2028-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P134 cells | Cell therapy | 1e+08 cells | Other |
| Subject | P134 cells | Cell therapy | 3e+08 cells | Other |
| Subject | P134 cells | Cell therapy | 5e+08 cells | Other |