Actively Recruiting
A Clinical Trial of P134 Cells in Recurrent Glioblastoma
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2026-02-18
26
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial of P134 Cells in Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide voluntary written informed consent
- Be 18 to 70 years old, male or female
- Have recurrent or progressive glioblastoma diagnosed as grade 4 (IDH wild-type) by pathology
- Have positive CD44 or CD133 antigen expression in tumor tissue (only for Phase 2 dose expansion)
- Have at least one measurable lesion no larger than 3 cm by imaging
- Have received prior radiation therapy and/or temozolomide or bevacizumab
- Be suitable for craniotomy and implantation of an Ommaya reservoir for treatment
You will not qualify if you...
- Have a history of severe allergy or allergy to cell products
- Received biologic anti-tumor therapy within 6 weeks before blood collection
- Received radiotherapy or surgery within 4 weeks before blood collection, except certain minor procedures
- Received chemotherapy, hormone therapy (excluding replacement), or immunomodulatory therapy within 2 weeks before blood collection
- Received traditional Chinese medicine with clear anticancer effects within 1 week before blood collection
- Have unresolved side effects from previous anti-tumor treatments greater than Grade 1 (except certain minor conditions)
- Have tumor spread to brainstem or spinal cord
- Have serious neurological diseases besides brain tumors (e.g., meningitis, encephalitis, epilepsy)
- Have primary immunodeficiency or autoimmune diseases requiring medication
- Are using or require long-term immunosuppressive drugs except low-dose corticosteroids
- Have history of bone marrow or organ transplantation or are awaiting transplant
- Test positive for hepatitis B, hepatitis C, syphilis, or HIV
- Participated previously in gene therapy or cell therapy trials
- Are pregnant or breastfeeding
- Have had other cancers within 5 years except certain low-risk types
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
Z
Zhang Yuping
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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