Actively Recruiting
H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-03-30
30
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the feasibility, safety and efficacy of H3K27M-specific engineered immune effector (EIE) therapy in patients with high-risk, H3K27M-positive diffuse midline glioma/diffuse intrinsic pontine glioma. Another goal of the study is to learn more about the function of the anti-H3K27M EIE cells and their persistency in patients.
CONDITIONS
Official Title
H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and provide written informed consent
- Age between 2 and 70 years old
- Recurrent or refractory diffuse midline glioma or diffuse intrinsic pontine glioma with confirmed H3K27M mutation and documented lesions
- Have received standard care such as surgery with concurrent radio-chemotherapy
- Receiving no dexamethasone or 4 mg/day or less at leukapheresis
- Karnofsky performance score of 60 or higher
- Life expectancy greater than 3 months
- Adequate bone marrow, liver, and kidney function as defined by specific blood count and enzyme levels
- Peripheral blood absolute lymphocyte count above 0.8 x 10^9/L
- Adequate heart function
- Willingness to follow doctors' instructions
- Women of reproductive potential (15-49 years) must have a negative pregnancy test within 7 days before study start
- Male and female patients of reproductive potential must agree to use birth control during the study and 3 months after
You will not qualify if you...
- Prior gliadel implantation within 4 weeks before study start or current antibody-based therapies
- HIV positive
- Uncontrolled tuberculosis infection
- History of autoimmune disease or conditions requiring long-term steroids or immunosuppressive therapies
- History of allergic disease or allergy to immune cells or study product
- Currently enrolled in another immune cell clinical study
- Investigator opinion that participant may not be eligible or able to comply with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
Lung-Ji Chang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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