A Clinical Trial of P134 Cells in Recurrent Glioblastoma

NCT ID: NCT07318818

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-13
• Study Completion Date: 2028-08-31

Brief Summary

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.

Conditions

Recurrent Glioblastoma IDH Wildtype

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

P134 cell

Group Type: EXPERIMENTAL

P134 cell injection

Intervention Type: BIOLOGICAL

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.

Interventions

P134 cell injection

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Voluntary written informed consent.

2. 18-70 years of age (inclusive), male or female.

3. Recurrent or progressive glioblastoma, histopathologically or molecularly diagnosed consistent with grade 4 glioblastoma (IDH wild-type) (refer to WHO Classification of Central Nervous System Tumors, 5th Edition, 2021).

4. Positive CD44 or CD133 antigen expression in tumor tissue confirmed by IHC, defined as ≥1% of tumor cells showing positive CD44 or CD133 IHC staining, regardless of intensity (applicable only in Phase II dose expansion study).

5. Patient has received prior radiation therapy and/or temozolomide/bevacizumab.

6. The investigator confirmed that the patient was suitable for craniotomy cerebrospinal fluid shunt and accessory (Ommaya reservoir) implantation.

Exclusion Criteria

1. Highly allergic constitution or history of severe allergy, or allergy to related cell products

2. Received an approved or other investigational anticancer therapy within 2 weeks prior to PBMC collection or within 5 half-lives of the agent, whichever is longer, including, but not limited to: chemotherapy, radiation therapy, surgery (except diagnostic surgery), targeted therapy, cell infusion therapy, hormone therapy (except hormone replacement therapy), and traditional Chinese medicine therapy with a clear anticancer indication (traditional Chinese medicine may undergo a 1-week washout period).

3. The adverse reactions caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 as evaluated by NCI CTCAE v5.0 (except alopecia, skin pigmentation, leukoplakia, etc. which are assessed as having no safety risk).

4. Tumor metastasis to the brainstem or spinal cord.

5. Patients with primary immunodeficiency disease, autoimmune diseases requiring medication (such as Crohn 's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus), or previous history of autoimmune diseases of the nervous system (such as multiple sclerosis, Parkinson' s disease).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tasly Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TSL-B2172-001

Identifier Type: -

Identifier Source: org_study_id