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A Clinical Trial of P134 Cells in Recurrent Glioblastoma

StatusRecruiting
PhasePhase 1/2
Started2026-01-05
View on ClinicalTrials.gov ↗

Amendment history

2026-02-13
Not Yet Recruiting→Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01-13→confirmed 2026-01-05
Enrollment target24→26
Eligibility criteria+1,662 characters
[...] tensity (applicable only in Phase II dose expansion study). At least one measurable lesion meeting RANO 2.0 criteria and having a radiographically assessed measurable lesion ≤ 3 cm in longest diameter Patient has received prior radiation therapy and/or temozolo [...] tory of severe allergy, or allergy to related cell products ReceivedReceipt anof approvedbiologic anti-tumor therapy (including monoclonal or otherbispecific investigational anticancerantibody-targeted therapy, immune checkpoint inhibitor therapy, etc.) within 6 weeks prior to PBMC collection; receipt of radiotherapy or surgery within 4 [...] [...]
Secondary endpoints1 to 8 entries
Recommended Phase 2 Dose (RP2D) Objective responseResponse rateRate (ORR) Disease Control Rate (DCR) Progression-Free Survival (PFS) Duration of Response (DOR) Time to Response (TTR) 1-year OS Rate Overall Survival
Primary endpoints1 to 3 entries
Dose limiting toxicities (DLTs) Maximum tolerated dose (MTD)
2025-12-19
Original filing
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.
Trial Details
NCT Number NCT07318818
Lead Sponsor Tasly Pharmaceutical Group Co., Ltd
Conditions Recurrent Glioblastoma IDH Wildtype
Enrollment 26 participants
Start Date 2026-01-05
Primary Completion 2028-02-29 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-18