Trials Sponsors Conditions Drugs Pricing

Conditions

Recurrent Glioblastoma IDH Wildtype

Outcome Measures

Primary Outcomes (3)

Dose limiting toxicities (DLTs)
Proportion of participants with dose-limiting toxicities (DLTs) as assessed by CTCAE version 6.0 in the dose-escalation phase
From the first dose up to Day 28 post-first dose
Adverse events (AEs)
Incidence and severity of adverse events (safety and tolerability) as assessed by CTCAE version 6.0 in the dose-escalation phase.
Through study completion, an average of two and a half years
Maximum tolerated dose (MTD)
The highest dose level with less than 33% of participants experiencing dose-limiting toxicities (DLTs) as assessed by CTCAE version 6.0 in the dose-escalation phase.
From the first dose up to Day 28 after the first dose.

Secondary Outcomes (8)

Recommended Phase 2 Dose (RP2D)
From study enrollment to Day 28 after the last dose of participants in the dose-escalation phase
Objective Response Rate (ORR)
Through study completion, an average of two and a half years
Disease Control Rate (DCR)
Through study completion, an average of two and a half years
Progression-Free Survival (PFS)
Through study completion, an average of two and a half years
Duration of Response (DOR)
Through study completion, an average of two and a half years
+3 more secondary outcomes

Other Outcomes (3)

Cytokinetics
From within 24 hours before the first CAR-T cell infusion through Day 28 after the last infusion, an average duration of five months
Cytokinetics
From within 24 hours before the first CAR-T cell infusion through Day 28 after the last infusion, an average duration of five months
Immunogenicity
From within 24 hours before the first CAR-T cell infusion through Day 28 after the last infusion, an average duration of five months.

Study Arms (1)

P134 cell

EXPERIMENTAL

Biological: P134 cell injection

Interventions

P134 cell injectionBiological

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.

P134 cell

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntary written informed consent.
years of age (inclusive), male or female.

Sponsors & Collaborators

Tasly Pharmaceutical Group Co., Ltd
Industrylead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

Li Nannan, Dr.CONTACT+8613284616878 Nannanli1992@163.com

Zhang Wei, Prof.PRINCIPAL INVESTIGATOR

Li Guanzhang, Dr.SUB INVESTIGATOR

Li Nannan, Dr.SUB INVESTIGATOR

Study Officials

Zhang Wei, Prof.
Beijing Tiantan Hospital, Capital Medical University, Beijing, P.R.China
PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Yuping

CONTACT

+8615022490519 zhangyuping90@taslypharma.com

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

January 6, 2026

Study Start

January 5, 2026

Actual (reported)

Primary Completion

February 29, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

Highly allergic constitution or history of severe allergy, or allergy to related cell products
Receipt of biologic anti-tumor therapy (including monoclonal or bispecific antibody-targeted therapy, immune checkpoint inhibitor therapy, etc.) within 6 weeks prior to PBMC collection; receipt of radiotherapy or surgery within 4 weeks prior to PBMC collection (excluding placement of vascular access devices; a 1-week washout period is acceptable for diagnostic biopsy surgeries); receipt of chemotherapy, hormone therapy (excluding hormone replacement therapy), or non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, cyclophosphamide, methotrexate, tumor necrosis factor, etc.) within 2 weeks prior to PBMC collection; receipt of traditional Chinese medicine therapy with a clear anticancer indication within 1 week prior to PBMC collection.
The adverse reactions caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 as evaluated by NCI CTCAE v6.0 (except alopecia, skin pigmentation, leukoplakia, etc. which are assessed as having no safety risk).
Tumor metastasis to the brainstem or spinal cord.
Suffering from other serious neurological diseases other than brain tumors, such as meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, amyotrophic lateral sclerosis, spinal muscular atrophy, nerve paralysis, uncontrolled epilepsy, etc.
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).
Receiving or requiring long-term use of immunosuppressive agents (except for physiological doses of systemic corticosteroids ≤ 10 mg/day prednisone equivalent, short-term ≤ 7 days corticosteroids for allergies, or topical glucocorticoids).
Trial participants who have a previous history of allogeneic bone marrow transplantation or organ transplantation, or are awaiting organ transplantation.
HBsAg positive and HBV DNA positive, HCV Ab positive and HCV RNA positive; Treponema pallidum antibody positive; human immunodeficiency virus (HIV) antibody positive.
Prior receipt of any gene therapy or cell therapy trial participant.
Pregnant or lactating women.
History of malignancy other than glioma within 5 years (except for adequately treated carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate cancer, or stage I cervical cancer, which in the opinion of the investigator carries a minimal risk of recurrence).

A Clinical Trial of P134 Cells in Recurrent Glioblastoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (8)

Other Outcomes (3)

Study Arms (1)

P134 cell

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (8)

Other Outcomes (3)

Study Arms (1)

P134 cell

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations