Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
- Trial number:
- NCT04388033
- Trial phase:
- 1, 2
- Study type:
- Immunotherapy
- Overall status:
- Recruiting
Study start date
December, 2020
Scientific title
Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
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.
Age ≥ 18 years; Male or Female.Treatment-naïve patients after Resection of Glioblastoma. Histologically confirmed Glioblastoma. KPS ≥ 60 White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment. Patients must be able to understand the investigational nature of the study and provide informed consent.
Study design
Primary purpose:
Treatment, Allocation:
N/A, Intervention model:
Single Group Assignment, Masking:
None (Open Label),
Conditions
Glioblastoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Neoplasms, Nerve Tissue, Vaccines, Immunologic Factors
Other study ID numbers
MDKZJU-DCf12-2019408
Choose trial site (2)
The Second Affiliated hospital of Zhejiang University School of Medicine
Shangcheng District, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China