Actively Recruiting
Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection
Led by Dushu Lake Hospital Affiliated to Soochow University · Updated on 2025-08-19
25
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old, male or female
- At least one measurable lesion with biopsy or histopathological confirmation of high-grade glioma (WHO grade 3-4)
- Positive B7-H3 expression on tumor tissue within the past 6 months
- Karnofsky Performance Status (KPS) of 60 or higher
- Expected survival of more than 3 months
- Normal bone marrow, liver, and kidney function based on laboratory tests before first QH104 injection
- No significant hereditary diseases
- Normal heart function with ejection fraction above 55%
- No bleeding or coagulation disorders
- For women of childbearing age (15-49 years), negative pregnancy test within 7 days before treatment and willingness to use contraception during the study and for 3 months after last infusion
- Signed informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Organ failure including severe heart (Class III or IV), liver (Child-Pugh grade C), kidney (stage 4 or higher), lung failure, or central nervous system abnormalities
- Having a second active tumor
- Active untreated infections such as hepatitis B, hepatitis C, or HIV
- Severe uncontrolled autoimmune or systemic diseases
- Current systemic steroid treatment (except inhaled steroids)
- Chronic diseases requiring immune or hormonal therapy
- Allergy to immunotherapy or related cells
- History of organ transplantation or awaiting transplantation
- Participation in another clinical trial within the last 30 days
- Other conditions making the participant unsuitable for the trial per investigator's judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dushu Lake Hospital Affiliated to Soochow University
Suzhou, Jiangsu, China, 215125
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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