Status:
RECRUITING
Allogeneic γδT Cells in Glioblastoma
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Peking University
Changping Laboratory
Conditions:
Glioblastoma (GBM)
Glioblastoma Multiforme (GBM)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 cell...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07144735
Start Date
April 1 2025
End Date
December 1 2030
Last Update
August 27 2025
Active Locations (3)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
2
Zhengzhou Second Hospital
Zhengzhou, Henan, China, 450052
3
Henan Academy of Innovations in Medical Science
Zhengzhou, Henan, China, 451162