A Clinical Trial of P134 Cells in Recurrent Glioblastoma

Tasly Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Recurrent Glioblastoma IDH Wildtype

Treatments: Biological: P134 cell injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07318818

TSL-B2172-001

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

P134 cell

Experimental group

Treatment:

Biological: P134 cell injection