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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

H3K27M-specific Immune Effector Cells Targeting DMG/DIPG

H3K27M-specific Engineered Immune Effectors (EIE) Targeting Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Abilities to understand and the willingness to provide written willing to sign a consent form; 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. Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body), 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

H3K27M-EIEs

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

Locations (1)

Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China