Overview
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-nave patients after resection of glioblastoma.
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.
Eligibility
Inclusion Criteria:
- Age 18 years; Male or Female.
- Treatment-nave 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.
Exclusion Criteria:
- Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
- Those with severe autoimmune diseases or immunodeficiency diseases.
- Those who are expected to take systemic corticosteroids within three months.
- Those who needs long-term usage of immunosuppressive agents.
- Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
- Those who plan to receive any other anti-tumor treatment during the trial.
- Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
- Patients with other malignant tumors.
- Those with active infections, etc.
- Suspected or confirmed a history of alcohol and drug abuse.
- Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
- Women who are pregnant or nursing.
- Women of childbearing age who refuse to contraception.
- Active participation in another clinical treatment trials.
- According to the judgment of the investigator, other conditions that the plan cannot be followed.