RecruitingPhase 1Phase 2NCT07318818

A Clinical Trial of P134 Cells in Recurrent Glioblastoma

A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of P134 Cells in the Treatment of Recurrent Glioblastoma

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Enrollment

26 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Recurrent Glioblastoma, IDH-Wildtype

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy called P134 — engineered immune cells — that is injected directly into the fluid surrounding the brain and spinal cord to treat recurrent glioblastoma (an aggressive form of brain cancer that has come back after initial treatment). **You may be eligible if...** - You are 18 to 70 years old - You have confirmed recurrent or progressive glioblastoma (grade 4 brain cancer, IDH wild-type) - Your tumor expresses specific proteins (CD44 or CD133) on at least 1% of tumor cells - You have at least one measurable tumor under 3 cm - You have previously received radiation and/or temozolomide or bevacizumab - Your surgeon has confirmed you are suitable for an Ommaya reservoir (a small device implanted in the skull for drug delivery) **You may NOT be eligible if...** - You have a severe allergy history or allergy to cell-based products - You received immunotherapy or antibody treatments within 6 weeks before immune cell collection - You received radiotherapy or major surgery within 4 weeks before immune cell collection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALP134 cell injection

In 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 Level 1 adopts accelerated titration, and the Level 2 and Level 3 adopt the "3+3" design. In Phase 2 dose expansion, one or two dose levels will be selected based on integrated safety, efficacy, and other relevant data. Up to 10 participants will be enrolled per dose level (including subjects from the dose-escalation study).Participants will be enrolled sequentially from the lower dose level to the higher dose level: enrollment at the lower dose level will be completed first, followed by enrollment at the higher dose level.

Locations(1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

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NCT07318818

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