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Enrolling By Invitation NCT03914768

Immune Modulatory DC Vaccine Against Brain Tumor

Conditions: Diffuse Intrinsic Pontine Glioma or Glioblastoma

Sex: All
Ages: 1 Year – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 10
Sponsor: Shenzhen Geno-Immune Medical Institute

Location: Shenzhen Geno-immune Medical Institute Shenzhen Guangdong

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 Criteria

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 \ 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03914768). StuddyBuddy aggregates publicly available trial information.