Allogeneic γδ T cell therapy for glioblastoma
Allogeneic Gamma Delta (γδ) T Cells for the Treatment of Glioblastoma
This first-in-human trial will try locally delivered, genetically edited allogeneic γδ T cells (ABOUT γδT) to see if they are safe for adults with recurrent or progressive glioblastoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | bevacizumab, immunotherapy |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT07144735 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–70 with histologically confirmed glioblastoma that is progressive or recurrent after prior therapy, Karnofsky performance status ≥60, adequate blood counts and organ function, and ability to undergo contrast MRI are ideal candidates.
Not a fit: Patients with poor performance status (KPS <60), uncontrolled organ or marrow dysfunction, unresolved high-grade treatment toxicities, or inability to undergo MRI or travel to the study sites are unlikely to receive benefit.
Why it matters
Potential benefit: If successful, this approach could offer a new local immunotherapy option that helps eliminate residual tumor cells and reduce recurrence risk in glioblastoma patients.
How similar studies have performed: This specific allogeneic, gene-edited γδ T-cell approach is novel and first-in-human; other cell therapies for GBM (eg, CAR-T) have produced limited or mixed results but no established durable success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.