Allogeneic γδT Cells in Glioblastoma

NCT ID: NCT07144735

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2030-12-31

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 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.

Conditions

Glioblastoma (GBM); Glioblastoma Multiforme (GBM)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose

Dose 1: 7x10\^7 ABOUT γδT, local administration every 3-4 weeks

Group Type: EXPERIMENTAL

Allogeneic γδ T (ABOUT) cells

Intervention Type: DRUG

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

Medium dose

Dose 2: 1.1x10\^8 ABOUT γδT, local administration every 3-4 weeks

Group Type: EXPERIMENTAL

Allogeneic γδ T (ABOUT) cells

Intervention Type: DRUG

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

High dose

Dose 3: 1.6x10\^8 ABOUT γδT, local administration every 3-4 weeks

Group Type: EXPERIMENTAL

Allogeneic γδ T (ABOUT) cells

Intervention Type: DRUG

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

Interventions

Allogeneic γδ T (ABOUT) cells

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

Intervention Type: DRUG

Other Intervention Names

ARIH1 and BCL11b knockout γδ T cells; ARIH1KO/BCL11bKO γδ T cells

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: collaborator

Changping Laboratory

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chenlong YANG

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Zhengzhou Second Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Henan Academy of Innovations in Medical Science

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

vik.yang@pku.edu.cn

(+86)-135-1108-7060

Facility Contacts

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

Role: primary

vik.yang@pku.edu.cn

(+86)-135-1108-7060

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

Role: primary

vik.yang@pku.edu.cn

(+86)-135-1108-7060

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

Role: primary

vik.yang@pku.edu.cn

(+86)-135-1108-7060

Other Identifiers

M20250397

Identifier Type: -

Identifier Source: org_study_id