Diffuse Intrinsic Pontine Glioma or Glioblastoma Clinical Trial
Official title:
Immune Modulatory DC Vaccine Against Diffuse Intrinsic Pontine Glioma (DIPG) and Glioblastoma (GBM)
| Verified date | June 2020 |
| Source | Shenzhen Geno-Immune Medical Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 | Enrolling by invitation |
| Enrollment | 10 |
| Est. completion date | December 31, 2022 |
| Est. primary completion date | January 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Neurosurgery, Shenzhen Hospital, Southern Medical University | Shenzhen | Guangdong |
| China | Shenzhen Children's Hospital | Shenzhen | Guangdong |
| China | Shenzhen Geno-immune Medical Institute | Shenzhen | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Shenzhen Geno-Immune Medical Institute | Shenzhen Children's Hospital, Shenzhen Hospital of Southern Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety of infusion of autologous immunomodulatory DC Vaccine is assessed by the NCI CTCAE V4.0 criteria. | Safety of the vaccine will be assessed by monitoring for adverse events (AEs) based on scheduled laboratory assessments. | 2 years | |
| Primary | Overall survival (OS) at 12 months (OS12). | OS12 will be the clinical efficacy primary endpoint. For subjects who are still alive at 12 months, OS12 will be censored at the last contact date. OS will be estimated using the Kaplan-Meier method. | 12 months | |
| Secondary | Treatment response rate of DIPG or GBM | Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on brain MRI imaging analysis. | 6 months] | |
| Secondary | Overall survival Rate | Percentage of participants with objective response as determined by the investigator based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) | 1 year follow up | |
| Secondary | Progression-free survival rate | Progression-free Survival (PFS) as determined by the investigator based on RECIST v1.1 | 1 years | |
| Secondary | ELISPOT or antigen specific functional assays for evaluation of antigen specific immune response in patients | Tumor antigen specific immune response in the peripheral blood evaluated by ELISPOT or antigen specific functional assays. | 1 year | |
| Secondary | Magnetic resonance imaging for evaluation of disease progression and prognosis | The prognosis of GBM or DIPG will be determined by MRI | 1 years |