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Clinical Trials in China / NCT07501156
Starting soon Phase 1/2

H3K27M-specific Immune Effector Cells Targeting DMG/DIPG

NCT07501156 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Geno-Immune Medical Institute
Phase
Phase 1/2
Started
2027-06-30
Last updated
2026-08-27

Condition(s) studied

Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma

Investigational drug(s) / intervention(s)

H3K27M-EIEs

H3K27M-EIEs: 1 to 2 infusions, once a week, for 1x10\^5\~1x10\^7 EIEs/kg via intravenous injection each time

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Abilities to understand and the willingness to provide written informed consent; 2. ≥ 2 and ≤ 70 years old; 3. 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; 4. Karnofsky performance score (KPS) ≥ 60; 5. Life expectancy \>3 months; 6. 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; 7. Peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L; 8. Satisfactory heart functions; 9. 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 Criteria: 1. A prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies; 2. HIV positive; 3. Tuberculosis infection not under control; 4. History of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies; 5. History of allergic disease, or allergy to immune cells or study product; 6. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shenzhen Geno-immune Medical Institute Shenzhen Guangdong

More Shenzhen Geno-Immune Medical Institute trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07501156 on ClinicalTrials.gov ↗ ← All trials in China