NCT03392545

Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with malignant gliomas, prolonging survivals of patients.

Detailed description

High grade gliomas, such as glioblatoma (GBM) is an aggressive malignancy with a poor prognosis. The current strategy for newly diagnosed GBM patients includes surgery, chemotherapy and radiotherapy. Unfortunately, after the standard treatmetn,the median survival of GBM is only about one year. Once relapsed, there is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for high grade gliomas, especially after progression, have yet to be established. Newly diagnosed GBM patients experience recurrence in five or seven months after standard treatment. We will investigate whether combining radiotherapy with intratumoral and systemic administration of immune adjuvants will improve the treatment outcome of high grade gliomas. We will use several immune adjuvants that activate innate and adaptive immunity.

Conditions

• High Grade Glioma
• Glioblastoma
• Glioma of Brainstem
• Glioma, Malignant

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combined immune adjuvants and radiation	24 hours before the radiation, patients will be administrated poly I:C or CAR-T or TCR-T intratumorally and receive granulocyte macrophage colony stimulating factor 5 days after the radiation.

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-04-01
• Completion: 2020-06-01
• First posted: 2018-01-08
• Last updated: 2019-07-11

Locations

1 site across 1 country: China