Status:
UNKNOWN
Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Hangzhou Medical Biotechnology Co., Ltd
CyTIX.Inc
Conditions:
Glioblastoma
Glioma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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...
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 pha...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04388033
Start Date
December 1 2020
End Date
December 1 2023
Last Update
June 9 2020
Active Locations (2)
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1
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310051
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310051