Immune cells engineered to fight deadly childhood brain tumors enter human trials
NCT ID NCT07501156
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study tests a new therapy using a patient's own immune cells, engineered to target a specific mutation found in diffuse midline glioma and DIPG, aggressive brain tumors. About 30 participants with recurrent or refractory disease will receive one to two infusions of these cells. The goal is to see if the treatment is safe and can shrink tumors or slow progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- H3K27M-specific engineered immune effector cells (a type of immune cell therapy)
- What this could lead to
- If successful, this could provide a new treatment option for a rare and aggressive brain cancer that currently has few effective therapies.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply broadly. The therapy involves infusions of modified immune cells, which can cause serious side effects like inflammation or organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.