Immune Modulatory DC Vaccine Against Brain Tumor (NCT03914768) | Clinical Trial Compass
By InvitationPhase 1
Immune Modulatory DC Vaccine Against Brain Tumor
China10 participantsStarted 2026-05-31
Plain-language summary
This study is designed to treat patients who have been diagnosed with brain cancer, including glioblastoma (GBM) and diffuse intrinsic pontine glioma (DIPG). The treatment uses immunomodulatory vaccine generated by autologous dendritic cells (DCs) pulsed with genetically modified tumor cells or tumor-related antigens including neoantigens to inject into patients. Vaccine-induced T cell responses have been associated with improved survival. The study will evaluate the safety and potential benefit of the novel immunomodulatory DC vaccines.
Who can participate
Age range
1 Year – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Abilities to understand and the willingness to provide written informed consent. Assent will be obtained when appropriate based on the subjects age;
. Patients are ≥ 6 months and ≤ 80 years old;
. 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);
. Patients with adequate neurological function and epileptic symptoms that are well controlled;
. Observing the condition after surgery or without surgery;
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily focused on safety, what does that mean for what we currently know — or don't yet know — about whether this DC vaccine actually helps patients with glioblastoma or DIPG survive longer?
2The trial is 'enrolling by invitation only' — what would it take for you to refer me or my child to this study, and who decides whether someone gets that invitation?
3The trial is measuring overall survival at 12 months as a key outcome — based on where things stand right now, how does that compare to what I might expect from standard treatment alone?
4The vaccine is made from the patient's own cells, which sounds like a complex process — can you walk me through what that would actually involve in terms of procedures, timing, and how many visits or treatments we'd be committing to?
5Given that this is still in the safety-testing phase, are there standard-of-care treatments I should consider first, or alongside this, and how would participating in this trial affect those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of infusion of autologous immunomodulatory DC Vaccine is assessed by the NCI CTCAE V4.0 criteria.
. 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;
. Peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
Exclusion criteria
. A prior history of gliadel implantation 4 weeks before this study start or antibody based therapies;
. The patient was still using dexamethasone at a dose greater than 4 mg/day during mononuclear cell collection;
. Patients have a history of autoimmune diseases or other diseases requiring long-term use of hormones or immunosuppressive drugs;
. Patients with a history of allergies or allergies to immune cells and adjuvants of cellular products;
. Active infection with fever;
. Patients with neutropenia (\> 10 days) that are difficult to correct after treatment;
. Infection with bacteria, fungi or viruses, uncontrolled;
. Patients with HIV and those living with active HBV and HCV;