Tests a dendritic cell vaccine for brain tumors in children and adults

Trial details

Who runs it

Shenzhen Geno-Immune Medical Institute

Trial code

NCT03914768

Record updated

30 October 2026

Original description

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.Read full original descriptionShow less

Immune Modulatory DC Vaccine Against Diffuse Intrinsic Pontine Glioma (DIPG) and Glioblastoma (GBM)

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.

Inclusion: 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; Karnofsky performance score (KPS) ≥ 60;Life expectancy >3 months; 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; Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if seizure disorder is well controlled; Patients must be willing to follow the orders of doctors.

Exclusion: 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 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; 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; Infection with bacteria, fungi or viruses, uncontrolled; Patients with HIV and those living with active HBV and HCV; Important organ failure (heart, liver, kidney, lung); Patients with neutropenia (> 10 days) that are difficult to correct after treatment; Pregnant, pregnant and lactating women; Anything that researchers believe may increase the risk of subjects or interfere with test results.

ClinicalTrials.gov NCT03914768