New vaccine takes on deadly brain tumors in early trial
NCT ID NCT03914768
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests a custom-made vaccine for people with two serious brain cancers: glioblastoma (GBM) and diffuse intrinsic pontine glioma (DIPG). The vaccine is made from the patient's own immune cells and designed to teach the body to attack the tumor. The main goals are to check if the vaccine is safe and to see if it can help patients live longer. Up to 10 participants aged 6 months to 80 years will be enrolled.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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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1 year to 75 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. Assent will be obtained when appropriate based on the subjects age; 2. Patients are ≥ 6 months and ≤ 80 years old; 3. DIPG or GBM patients with existing or measurable tumors in the brain. Patients have received standard care of medication, such as gross total resection with concurrent radio chemotherapy (\~54 - 60 Gy, TMZ); 4. Patients with adequate neurological function and epileptic symptoms that are well controlled; 5. Observing the condition after surgery or without surgery; 6. Karnofsky performance score (KPS) ≥ 60;Life expectancy \>3 months; 7. Important organ function is satisfied: Cardiac ultrasound indicates a cardiac ejection fraction ≥50%; and there is no obvious abnormality in the electrocardiogram; blood oxygen saturation ≥90%; creatinine \<2.5 times normal range; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 times normal range; Total bilirubin ≤ 2.0 mg / dl; Hgb (hemoglobin) ≥ 80g / L; 8. Peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L; 9. Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if seizure disorder is well controlled; 10. Patients must be willing to follow the orders of doctors. Exclusion Criteria: 1. A prior history of gliadel implantation 4 weeks before this study start or antibody based therapies; 2. The patient was still using dexamethasone at a dose greater than 4 mg/day during mononuclear cell collection; 3. Patients have a history of autoimmune diseases or other diseases requiring long-term use of hormones or immunosuppressive drugs; 4. Patients with a history of allergies or allergies to immune cells and adjuvants of cellular products; 5. Active infection with fever; 6. Patients with neutropenia (\> 10 days) that are difficult to correct after treatment; 7. Infection with bacteria, fungi or viruses, uncontrolled; 8. Patients with HIV and those living with active HBV and HCV; 9. Pregnant, pregnant and lactating women; 10. Important organ failure (heart, liver, kidney, lung); 11. Patients who had previously been treated with cell therapy but were ineffective after physical examination were discussed and confirmed by team experts and were not suitable for re-treatment; 12. Anything that researchers believe may increase the risk of subjects or interfere with test results.
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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