Allogeneic γδT Cells in Glioblastoma

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Allogeneic γδT Cells in Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07144735
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking University Third Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma (GBM), Glioblastoma Multiforme (GBM)

Arms & Interventions

Arms

Experimental: Low dose

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

Experimental: Medium dose

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

Experimental: High dose

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

Interventions

Drug: - Allogeneic γδ T (ABOUT) cells

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.