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Recruiting NCT07144735

Allogeneic γδT Cells in Glioblastoma

No phase Interventional Glioblastoma (GBM) Glioblastoma Multiforme (GBM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Allogeneic γδ T (ABOUT) cells.
Who it may be relevant to
Registry conditions: Glioblastoma (GBM), Glioblastoma Multiforme (GBM). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Allogeneic Gamma Delta (γδ) T Cells for the Treatment of Glioblastoma

Overview

This first-in-human clinical study aims to evaluate the safety and feasibility of locally delivered, allogeneic γδ T cells (genetically edited with ARIH1 and BCL11b knockout, designated ABOUT γδT cells) in patients with glioblastoma multiforme (GBM). The engineered effector cells are delivered via localized administration to selectively target and eliminate residual GBM cells. ABOUT: ARIH1 and BCL11b knockOUT γδ T cells.

Interventions

  • Drug Allogeneic γδ T (ABOUT) cells
    Allogeneic γδ T cells genetically edited to knockout the ARIH1 and BCL11b genes.

Primary outcome measures

  • Incidence of Adverse Events (AEs) [Time frame: 3 months following ABOUT γδT cells administration]
  • Incidence of Dose-Limiting Toxicities (DLTs) [Time frame: 28 days following initial treatment with ABOUT γδT cells]
Secondary outcome measures (2)
  • Objective Response Rate (ORR) [Time frame: 3 months following ABOUT γδT cells administration]
  • Duration of response (DOR) [Time frame: 3 months following ABOUT γδT cells administration]

Eligibility criteria

Inclusion criteria

  • Male or female, age 18-70 years old (both ends included)
  • At least one evaluable lesion with previous biopsy or pathohistologic confirmation of glioblastoma (WHO grade IV), with imaging suggestive of continued progression or recurrence after comprehensive treatment
  • Karnofsky Performance Status (KPS) ≥ 60%
  • Life expectancy > 4 weeks
  • Patients who completed radiotherapy or systemic therapies (including temozolomide/bevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)
  • Must be able to undergo an MRI with contrast
  • Must have adequate organ and marrow function as defined below:
  • White blood cell count (WBC) ≥ 3 x 10\^9/L
  • Absolute neutrophil count (ANC) > 1 x 10\^9/L
  • Hemoglobin (Hb) ≥ 90 g/L
  • Platelet (PLT) ≥ 80×10\^9/L
  • Albumin transaminase (ALT) \& albumin transaminase (AST) < 1.5 × institutional upper limit of normal (ULN)
  • Serum creatinine (Cr) < 1.5 x institutional ULN
  • Total bilirubin < 1.5 x institutional ULN
  • PT \& PTT ≤ 1.25 x institutional ULN
  • No obvious hereditary diseases
  • Normal cardiac function with left ventricular ejection fraction >55%
  • No bleeding and coagulation disorders
  • Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to ABOUT γδT cell infusion and/or there aren't any indications of meningitis
  • Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  • Signed, written informed consent

Exclusion criteria

  • Active hepatitis B or C virus, HIV infection, or other untreated active infection
  • Pregnant and lactating women
  • Participants with organ failure
  • Participants with a chronic disease requiring immunologic or hormonal therapy
  • Participants with an allergy to immunotherapy and related cells
  • Participants with uncontrolled intercurrent illness
  • Participants with psychiatric illness/social situations that would limit compliance with study requirements
  • Participants with a history of organ transplantation or who are awaiting organ transplantation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Peking University Third Hospital — Beijing
  • Zhengzhou Second Hospital — Zhengzhou
  • Henan Academy of Innovations in Medical Science — Zhengzhou

Identifiers

NCT: NCT07144735 · M20250397

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗