Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07144735

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

Led by Peking University Third Hospital · Updated on 2025-08-27

18

Participants Needed

3

Research Sites

156 weeks

Total Duration

On this page

Sponsors

P

Peking University Third Hospital

Lead Sponsor

P

Peking University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and feasibility of a new treatment using genetically edited allogeneic gamma delta (γδ) T cells, called ABOUT γδT cells, in patients with glioblastoma multiforme (GBM). This first-in-human clinical study focuses on locally delivering these engineered cells, designed to selectively target and eliminate residual GBM cells after previous treatments. The study is led by Peking University Third Hospital and explores a novel approach to treating this aggressive brain tumor. The study involves three different dose levels of ABOUT γδT cells administered locally every 3 to 4 weeks: a low dose of 7x10^7 cells, a medium dose of 1.1x10^8 cells, and a high dose of 1.6x10^8 cells. Participants receive these treatments as part of a non-randomized, open-label trial without masking or placebo control. The treatments are given after previous therapies such as radiotherapy or systemic treatments, with a required waiting period before enrollment. Participants will be monitored closely for safety, including adverse events within 3 months and dose-limiting toxicities within 28 days after the first treatment. Researchers will also assess treatment responses and their duration during the first 3 months following cell administration. The study requires regular evaluations including MRI scans and lab tests to confirm organ function and disease status. The total participation period varies, with ongoing follow-up to track safety and treatment effects.

CONDITIONS

Brief Title

Allogeneic γδT Cells in Glioblastoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Completed radiotherapy or systemic therapies at least 4 weeks prior to enrollment with treatment-related toxicities ≤ grade 1 (except alopecia or leukoplakia)
  • Ability to undergo MRI with contrast
  • Adequate organ and marrow function as defined by specific blood counts and liver, kidney, and coagulation test thresholds
  • No obvious hereditary diseases
  • Normal cardiac function with left ventricular ejection fraction >55%
  • No bleeding or coagulation disorders
  • No positive blood cultures or signs of meningitis within 48 hours before ABOUT γδT cell infusion
  • Fertile women must have a negative pregnancy test within 7 days before treatment and agree to use contraception during the trial and for 6 months after last infusion
  • Signed, written informed consent
Not Eligible

You will not qualify if you...

  • Active hepatitis B or C virus, HIV infection, or other untreated active infection
  • Pregnant or lactating women
  • Organ failure
  • Chronic disease requiring immunologic or hormonal therapy
  • Allergy to immunotherapy or related cells
  • Uncontrolled intercurrent illness
  • Psychiatric illness or social situations limiting study compliance
  • History of organ transplantation or awaiting organ transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated every 3 to 4 weeks, duration depends on treatment plan

Participants receive local administration of Allogeneic γδ T cells every 3 to 4 weeks at one of three dose levels depending on cohort assignment.

Visits every 3 to 4 weeks for cell administration

Follow-up

Duration - Up to 3 months following treatment

Participants are monitored for adverse events, dose-limiting toxicities, and treatment response following cell administration.

Approximately monthly visits for up to 3 months

Trial Site Locations

Total: 3 locations

1

Peking University Third Hospital

Beijing, Beijing Municipality, China, 100191

Actively Recruiting

2

Zhengzhou Second Hospital

Zhengzhou, Henan, China, 450052

Actively Recruiting

3

Henan Academy of Innovations in Medical Science

Zhengzhou, Henan, China, 451162

Actively Recruiting

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Research Team

C

Chenlong YANG, M.D., Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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