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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: CyTIX.Inc; Hangzhou Medical Biotechnology Co., Ltd
• Treatments: Interleukin-12; Temozolomide; Vaccines

Criteria

Inclusion Criteria:

1. Age ≥ 18 years; Male or Female.

2. Treatment-naïve patients after Resection of Glioblastoma.

3. Histologically confirmed Glioblastoma.

4. KPS ≥ 60

5. White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.

6. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.

7. Patients must be able to understand the investigational nature of the study and provide informed consent.

Exclusion Criteria:

1. Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.

2. Those with severe autoimmune diseases or immunodeficiency diseases.

3. Those who are expected to take systemic corticosteroids within three months.

4. Those who needs long-term usage of immunosuppressive agents.

5. Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.

6. Those who plan to receive any other anti-tumor treatment during the trial.

7. 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.

8. Patients with other malignant tumors.

9. Those with active infections, etc.

10. Suspected or confirmed a history of alcohol and drug abuse.

11. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.

12. Women who are pregnant or nursing.

13. Women of childbearing age who refuse to contraception.

14. Active participation in another clinical treatment trials.

15. According to the judgment of the investigator, other conditions that the plan cannot be followed.