NCT04388033

Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma.

Detailed description

This clinical trail includes two phases: basic treatment phase and immunotherapy phase. In basic treatment phase, patients will receive concomitant radiation and TMZ-chemotherapy. In immunotherapy phase, besides maintenance chemotherapy with TMZ, Fusion cells will be administered with IL-12 to enhance the immunity of patients.

Conditions

• Glioblastoma
• Glioma
• Neoplasms, Neuroepithelial
• Neuroectodermal Tumors
• Neoplasms
• Neoplasms, Nerve Tissue
• Vaccines
• Immunologic Factors

Interventions

Type	Name	Description
BIOLOGICAL	Dendritic Cell/Tumor Fusion Vaccine	Vaccine is derived from the participants dendritic cells and tumor cells.
DRUG	Interleukin-12	Given subcutaneously at dose of 6ug twice for interval of one hour.
DRUG	Temozolomide	Following concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days) , maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2020-05-14
• Last updated: 2020-06-09

Locations

2 sites across 1 country: China