Diffuse Midline Glioma or Diffuse Intrinsic Pontine GliomaPhase 1/2NCT07501156
H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
A Phase 1/2 study testing H3K27M-EIEs in people with Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma
- What is being tested?
- H3K27M-EIEs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2027to 30 Jun 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
- Life expectancy >3 months;
- 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;
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- Peripheral blood absolute lymphocyte count must be above 0.8×10^9/L;
- Satisfactory heart functions;
- 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 cannot join
- 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;
- History of allergic disease, or allergy to immune cells or study product;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000
Lung-Ji Chang, Ph.D, +86 0755-86573763, c@szgimi.org
About this study
Official title: H3K27M-specific Engineered Immune Effectors (EIE) Targeting Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma
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.
Read the detailed description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Diffuse midline glioma or Diffuse Intrinsic Pontine Glioma (DIPG) represent one of the most devastating pediatric central nervous system malignancies. Despite decades of clinical investigation, the standard of care remains focal radiotherapy, which offers only transient symptomatic improvement without altering the uniformly fatal disease trajectory. The median overall survival remains approximately 11 months from diagnosis, with five-year overall survival below 1%. No effective salvage therapies exist following disease progression, and conventional cytotoxic chemotherapy has failed to improve outcomes. The identification of the clonal H3K27M mutation in histone H3 as a driver of tumorigenesis has provided a unique tumor-specific antigenic target, distinguishing this entity from adult high-grade gliomas and opening avenues for innovative precision immunotherapy.
The H3K27M mutation serves as an ideal immunotherapeutic target due to its uniform expression across tumor cells, its absence in normal healthy tissues, and its critical role in oncogenesis. This study incorporates the production and adoptive transfer of autologous H3K27M-specific EIEs. Peripheral blood mononuclear cells (PBMCs) are collected via leukapheresis and stimulated with H3K27M antigen primed autologous dendritic cells. The resultant EIEs phenotypically characterized for CD8+, CD4+ and CD56+ predominance with antigen specificity. Here, the study aims to evaluate the safety and efficacy of the H3K27M-specific EIEs in DMG/DIPG patients.
- Being tested
- H3K27M-EIEs
- Keywords
- EIE, DIPG, H3K27M
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H3K27M-EIEsBiological
1 to 2 infusions, once a week, for 1x10^5~1x10^7 EIEs/kg via intravenous injection each time
| Study group | Role | What they receive |
|---|---|---|
| H3K27M-EIEs | Experimental | Not described Receives: Biological: H3K27M-EIEs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one month
Secondary outcomes (3)
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.
Measured: up to one month
Ability of H3K27M-EIE cells to induce cancer-specific reactions
ELISPOT measurement of target-specific T cells in blood sample
Measured: after 1 month from H3K27M-EIE cell infusion until 12 months after infusion
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.
Measured: after 1 month from H3K27M-EIE cell infusion until 24 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start30 Jun 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Midline Glioma or Diffuse Intrinsic Pontine GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501156
- Sponsor's protocol ID
- GIMI-IRB-26003
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H3K27M-specific Engineered Immune Effectors (EIE) Targeting Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma
- ClinicalTrials.gov ID
- NCT07501156
- Acronym / sponsor ID
- GIMI-IRB-26003
- Keywords
- EIE, DIPG, H3K27M
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 30 Jun 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Diffuse midline glioma or Diffuse Intrinsic Pontine Glioma (DIPG) represent one of the most devastating pediatric central nervous system malignancies. Despite decades of clinical investigation, the standard of care remains focal radiotherapy, which offers only transient symptomatic improvement without altering the uniformly fatal disease trajectory. The median overall survival remains approximately 11 months from diagnosis, with five-year overall survival below 1%. No effective salvage therapies exist following disease progression, and conventional cytotoxic chemotherapy has failed to improve outcomes. The identification of the clonal H3K27M mutation in histone H3 as a driver of tumorigenesis has provided a unique tumor-specific antigenic target, distinguishing this entity from adult high-grade gliomas and opening avenues for innovative precision immunotherapy.
The H3K27M mutation serves as an ideal immunotherapeutic target due to its uniform expression across tumor cells, its absence in normal healthy tissues, and its critical role in oncogenesis. This study incorporates the production and adoptive transfer of autologous H3K27M-specific EIEs. Peripheral blood mononuclear cells (PBMCs) are collected via leukapheresis and stimulated with H3K27M antigen primed autologous dendritic cells. The resultant EIEs phenotypically characterized for CD8+, CD4+ and CD56+ predominance with antigen specificity. Here, the study aims to evaluate the safety and efficacy of the H3K27M-specific EIEs in DMG/DIPG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H3K27M-EIEs | Experimental | Biological: H3K27M-EIEs |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- Life expectancy >3 months;
Key exclusion criteria (6 listed)
- 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;
- History of allergic disease, or allergy to immune cells or study product;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H3K27M-EIEs1 to 2 infusions, once a week, for 1x10^5~1x10^7 EIEs/kg via intravenous injection each time | Biological | H3K27M-EIEs |
Primary outcome
Percentage of adverse effects after H3K27M-EIE injection
Time frame: 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.
3 secondary outcomes
Rate of successful H3K27M-EIE generation
Time frame: up to one month
Ability of H3K27M-EIE cells to induce cancer-specific reactions
Time frame: after 1 month from H3K27M-EIE cell infusion until 12 months after infusion
Ability of H3K27M-EIE cells inducing anti-cancer reactions
Time frame: after 1 month from H3K27M-EIE cell infusion until 24 months after infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing H3K27M-EIEs in people with Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lung-Ji Chang, Ph.D (+86 0755-86573763, c@szgimi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adverse effects after H3K27M-EIE injection (time frame: up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.