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)
Percentage of adverse effects after H3K27M-EIE injection — up to one month To assess the safety of autologous H3K27M-EIEs in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.
Trial sites (1)
Facility
City
Region
Status
Shenzhen Geno-immune Medical Institute
Shenzhen
Guangdong
More Shenzhen Geno-Immune Medical Institute trials in China
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.