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Clinical Trials in China / NCT03914768
Starting soon Phase 1

Immune Modulatory DC Vaccine Against Brain Tumor

NCT03914768 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Geno-Immune Medical Institute
Phase
Phase 1
Started
2026-12-31
Last updated
2026-08-26

Condition(s) studied

Diffuse Intrinsic Pontine Glioma or Glioblastoma

Investigational drug(s) / intervention(s)

Immunomodulatory DC vaccine to target DIPG and GBM

Immunomodulatory DC vaccine to target DIPG and GBM: This study will inject DC vaccine cells near lymphoid tissue close to the tumor. The patient will receive intravenous cyclophosphamide (200 mg/m2) or oral (cytoxan) before the vaccine, followed by DC vaccine and intravenous bevacizumab (15 mg/kg) the next day. The cells will be repeatedly infused every month for six consecutive months depending on the response and the condition of the patient. The amount of DC vaccine cells per injection is based on prior report at 5-10x106. An initial dose escalation scheme will be imposed.

Study 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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shenzhen Geno-immune Medical Institute Shenzhen Guangdong

More Shenzhen Geno-Immune Medical Institute trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03914768 on ClinicalTrials.gov ↗ ← All trials in China