This is an open-label, single-arm, dose-escalation and expansion Phase 1/2 clinical study to evaluate the safety, tolerability and efficacy of P134 cells in the treatment of recurrent glioblastoma, to explore the MTD and RP2D, and to observe the cytokinetic profile of CAR-T cells in the cerebrospinal fluid of patients. The subjects are patients with recurrent or progressive glioblastoma who are diagnosed as grade 4 glioblastoma (IDH wild-type) by histopathology or molecular pathology.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
In this Phase 1 dose-escalation study, P134 cell dosing and safety are evaluated using an accelerated titration initial dose followed by a "3+3" design. The starting dose is 1 × 10⁸ CAR⁺ T cells, administered intratumorally or intraventricularly via an Ommaya reservoir. Three dose levels are planned: Level 1: 1 × 10⁸ CAR⁺ T cells, Q2W Level 2: 3 × 10⁸ CAR⁺ T cells, Q2W Level 3: 5 × 10⁸ CAR⁺ T cells, Q2W The dose-limiting toxicity (DLT) observation period is 28 days after the first dose for each subject. In Phase 2 dose expansion, one or two dose levels will be selected based on integrated safety, efficacy, and other relevant data. Each selected cohort will be expanded to 20 participants for further evaluation of safety and efficacy.
Adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: Through study completion, an average of two and a half years
Objective response rate (ORR)
Number of trial participants who achieved a complete response (CR) or partial response (PR) according to the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
Time frame: Through study completion, an average of two and a half years
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