H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
Trial statusNot yet recruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
H3K27M-EIEs
Biological/Vaccine1 to 2 infusions, once a week, for 1x10\^5\~1x10\^7 EIEs/kg via intravenous injection each time
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: H3K27M-EIEsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of adverse effects after H3K27M-EIE injection
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.
Time frame
up to one monthSecondary outcomes
1
Rate of successful H3K27M-EIE generation
The percentage of successful H3K27M-EIE generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated.
Time frame
up to one month2
Ability of H3K27M-EIE cells to induce cancer-specific reactions
ELISPOT measurement of target-specific T cells in blood sample
Time frame
after 1 month from H3K27M-EIE cell infusion until 12 months after infusion3
Ability of H3K27M-EIE cells inducing anti-cancer reactions
Objective response (complete response (CR) + partial response (PR)) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lesions (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame
after 1 month from H3K27M-EIE cell infusion until 24 months after infusionSponsors and contacts
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Source ClinicalTrials.gov
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