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NCT Number: NCT07144735

Allogeneic γδT Cells in Glioblastoma

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogeneic γδ T (ABOUT) cells

Drug

Allogeneic γδ T cells genetically edited to knockout the ARIH1 and BCL11b genes.

Other names: ARIH1 and BCL11b knockout γδ T cells, ARIH1KO/BCL11bKO γδ T cells

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: 3 months following ABOUT γδT cells administration

    Defined as the incidence of ≥ Grade 3-4 adverse events related to ABOUT γδT cells according to common terminology criteria for adverse events (CTCAE) v6.0.

  2. Incidence of Dose-Limiting Toxicities (DLTs)

    Time frame: 28 days following initial treatment with ABOUT γδT cells

    Defined as events attributable to ABOUT γδT cells infusion within 28 days post-infusion. Grade 3-4 acute graft-versus-host disease (GvHD) according to the Mount Sinai Acute GvHD International Consortium criteria; Grade 3 or higher cytokine release syndrome (CRS) lasting more than 2 weeks, according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria; Any ABOUT γδT cells-related AE requiring intubation; Grade 4 non-hematologic toxicities.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 3 months following ABOUT γδT cells administration

    According to modified RANO criteria, ORR is defined as proportion of subjects with confirmed CR and PR.

  2. Duration of response (DOR)

    Time frame: 3 months following ABOUT γδT cells administration

    According to modified RANO criteria, DOR is defined as time from the date when a response of confirmed CR/PR is first met to the date of confirmed disease progression or death.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

(+86)-135-1108-7060

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Changping Laboratory
  • Peking University

Registry information

Official study title

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

Acronym: ABOUT

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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