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RECRUITING

NCT06018363

PHASE1/PHASE2

Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection

Sponsor: Dushu Lake Hospital Affiliated to Soochow University

View on ClinicalTrials.gov

Summary

B7-H3 is expressed at low levels in normal tissues but overexpressed in various tumor tissues. The ubiquitous expression of B7-H3 in tumors of different grades is a key feature for brain gliomas. The immunohistochemistry study showed that B7-H3 is abundantly expressed on both glioma (especially high-grade glioma) cells and tumor-associated endothelial cells. For GBM, the expression of B7-H3 is intensely positive, especially on tumor cells and vascular endothelial cells, which makes B7-H3 a potential immunotherapeutic target. γδ T cells recognize tumor cells without being restricted by MHC molecules, and thus can be used in allogeneic therapy without the risk of causing graft-versus-host disease. This study is an open-label, single-arm, dose-escalation and dose-expansion clinical study aimed at evaluating the safety and efficacy of allogeneic B7-H3 CAR γδT in patients with malignant glioma.

Official title: Allogeneic B7-H3 CAR-γδT Cell Therapy Recurrent/Progressive High Grade Glioma（R/R HGG）

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-06-01

Completion Date

2027-12-31

Last Updated

2025-08-19

Healthy Volunteers

Conditions

Brain Gliomas High-Grade Gliomas GBM

Interventions

BIOLOGICAL

Allogenic B7-H3 CAR-γδT cell(QH104)

Dose escalation (3+3) : dose 1 (1 × 10\^7 CAR+cells) , dose 2 (3 × 10\^7 CAR+cells), dose 3 (6× 10\^7 CAR+cells), once every 4 weeks via an Ommaya reservoir or intrathecal administration. Dose expansion 1: dose of RP2D, once every 4 weeks via an Ommaya reservoir or intrathecal administration. Dose expansion 2: 3 × 10\^7 CAR+cells, every two weeks for three consecutive months, then changed to once every 4 weeks via an Ommaya reservoir or intrathecal administration.

Inclusion Criteria: * 1)Age 18-70 years old (both ends included), both male and female; * 2)At least one evaluable lesion, with previous biopsy or histopathological confirmation of high-grade glioma (WHO grade 3-4), and after comprehensive treatment, imaging examination indicates continued progression or recurrence; * 3\) The pathological tissues removed by surgery can be used for immunohistochemical detection of target proteins (paraffin sections should be within half a year), and the expression of B7-H3 is positive; * 4\) KPS ≥ 60 points; * 5)Expected survival \> 3 months; * 6)Substantially normal bone marrow reserve function and normal liver and renal function (laboratory tests need to be fulfilled before receiving QH104 Cell Injection for the first time):White blood cell count (WBC) ≥ 3 x 10\^9/L;Lymphocyte count (LY) ≥ 0.8 x 10\^9/L;Hemoglobin (Hb) ≥ 90g/L;Platelet (PLT) ≥80×10\^9/L;Albumin transaminase (ALT) \& albumin transaminase (AST) \<1.5×ULN;Serum creatinine (Cr) \<1.5 x ULN;Total bilirubin \< 1.5 x ULN;PT \& PTT ≤ 1.25 x ULN. * 7)No obvious hereditary diseases; * 8)Normal cardiac function with cardiac ejection index \>55%; * 9)No bleeding and coagulation disorders; * 10)Women of childbearing age (15-49 years old) 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 during the clinical trial and for 3 months after the last cell infusion; * 11\) Sign the informed consent form. Exclusion Criteria: * 1)Pregnant and lactating women; * 2)Those with organ failure:Heart: Class III and IV;Liver: up to grade C of the Child-Turcotte Liver -Function Classification;Kidney: chronic kidney disease stage 4 or above; renal insufficiency stage III or above;Lungs: symptoms of severe respiratory failure with involvement of other organs;Brain: central nervous system abnormalities or impaired consciousness; * 3)patients with combined second tumors; * 4)patients with active hepatitis B or C virus, HIV infection, or other untreated active infection; * 5)any severe, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis; * 6)Current systemic use of steroid cell (except for recent or current use of inhaled steroids) substances; * 7\) have a chronic disease requiring immunologic or hormonal therapy; * 8\) have an allergy to immunotherapy and related cells; * 9\) 10)Patients with a history of organ transplantation or who are awaiting organ transplantation; * 10)Participation in other clinical trials within the previous 30 days; * 11)Those who are not suitable for clinical trials for other reasons in the opinion of the investigator.

Locations (1)

Dushu Lake Hospital Affiliated to Soochow University

Suzhou, Jiangsu, China