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NCT03914768Not yet recruitingPhase 1

Immune Modulatory DC Vaccine Against Brain Tumor

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

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
10 (estimated)
First submitted
11 Apr 2019
Start date
31 Dec 2026
Primary completion date
31 May 2029
Lead sponsor
Shenzhen Geno-Immune Medical Institute
NCT number
NCT03914768

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 10
  • From 31 Dec 2026 to the primary completion date, 31 May 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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);

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 1 year to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shenzhen Geno-immune Medical Institute
Coordinator of this site? Confirm its status
ShenzhenChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.