NCT07501156 H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
| NCT ID | NCT07501156 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-03-18 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07501156 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 70 Years, studying Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07501156 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07501156 currently recruiting?
Yes, NCT07501156 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT07501156 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07501156 clinical trial?
NCT07501156 is sponsored by Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 30 participants.