H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-70
SponsorShenzhen Geno-Immune Medical Institute
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- H3K27M-EIEs
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov