Allogeneic γδ T cell therapy for glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study delivers allogeneic γδ T cells engineered with ARIH1 and BCL11b knockouts (ABOUT γδT) directly into the tumor region to target residual glioblastoma cells. Eligible patients are adults 18–70 with histologically confirmed recurrent or progressive GBM who have completed prior radiotherapy and systemic therapy at least four weeks earlier and meet performance and laboratory criteria. The primary focus is safety and feasibility, with close monitoring for adverse events, laboratory changes, and serial MRI imaging to observe local effects. Treatments are conducted at participating centers in Beijing and Zhengzhou with follow-up to document tolerability and any early signs of anti-tumor activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, age 18-70 years old (both ends included)
2. 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
3. Karnofsky Performance Status (KPS) ≥ 60%
4. Life expectancy \> 4 weeks
5. 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)
6. Must be able to undergo an MRI with contrast
7. 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
8. No obvious hereditary diseases
9. Normal cardiac function with left ventricular ejection fraction \>55%
10. No bleeding and coagulation disorders
11. 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
12. 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
13. Signed, written informed consent

Exclusion Criteria:

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

Where it's running

• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Zhengzhou Second Hospital
  Zhengzhou, Henan, China Recruiting
• Henan Academy of Innovations in Medical Science
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Chenlong YANG, M.D., Ph.D.
• Email: vik.yang@pku.edu.cn
• Phone: (+86)-135-1108-7060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.