Engineered immune cells for H3K27M-positive diffuse midline glioma and diffuse intrinsic pontine glioma
Tests engineered immune cells in people with H3K27M-positive diffuse midline glioma or pontine glioma.
Plain-language title generated from the registry record
Registry title: H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 2 to 70 whose diffuse midline glioma or diffuse intrinsic pontine glioma has come back or has not responded to treatment, and whose tumour has the H3K27M mutation.
- Age
- 2 to 70 years old.
- Sex
- All sexes can join.
- Disease stage
- Recurrent or refractory diffuse midline glioma or diffuse intrinsic pontine glioma with a confirmed H3K27M mutation and documented lesions. Karnofsky performance score of 60 or more. Life expectancy over 3 months.
- Earlier treatment
- Must have had standard care, such as gross total resection with radio-chemotherapy (about 54 - 60 Gy, TMZ). Must not take dexamethasone, or take 4 mg/day or less, at the time of leukopheresis.
- Biomarker or test result
- Confirmed H3K27M mutation. Blood counts, liver, kidney and heart function must be satisfactory; absolute lymphocyte count above 0.8×10^9/L.
Main reasons for not taking part
- Gliadel implant within 4 weeks before the study starts, or currently on antibody-based therapies
- HIV positive
- Tuberculosis infection that is not under control
- History of autoimmune disease or other disease needing long-term steroids or immunosuppressive treatment
- History of allergic disease, or allergy to immune cells or the study product
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 70 years old?
Source: NCT07501156, who can take part
Where in China
- Shenzhen Geno-immune Medical InstituteShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Geno-Immune Medical Institute
- Trial code
- NCT07501156
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
H3K27M-specific Engineered Immune Effectors (EIE) Targeting Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma
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.
Inclusion: Abilities to understand and the willingness to provide written informed consent; ≥ 2 and ≤ 70 years old; Recurrent or refractory diffuse midline glioma or diffuse intrinsic pontine glioma patients with confirmed H3K27M mutation and documented lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis; Karnofsky performance score (KPS) ≥ 60; Life expectancy >3 months; Satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; hemoglobin > 10 g/dL; platelets > 100000 /mm\^3; Bilirubin < 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5×ULN; creatinine < 1.5×ULN; Peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L; Satisfactory heart functions; Must be willing to follow the instructions of doctors; Women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.
Exclusion: A prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies; HIV positive; Tuberculosis infection not under control; History of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies; History of allergic disease, or allergy to immune cells or study product; Patients already actively enrolled in other immune cell clinical study; Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.