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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04388033
• Other study ID #: MDKZJU-DCf12-2019408
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2020
• Est. completion date: December 2023

Study information

• Verified date: December 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Hong Shen, MD
• Phone: 8613805730380
• Email: sh_2nd[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The Second Affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	CyTIX.Inc, Hangzhou Medical Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AE) / Serious Adverse Events (SAE)	AE/SAE associated with the intervention will be captured throughout the treatment portion of the study. All adverse events will be then compiled and these patients will be recorded.	2-3 years
Primary	Progression free survival (PFS) at 6 months	Assessed from this study start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up).	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary	Immunological Assays	Assays including Flow Cytometry and Elispot will be employed to determine if cellular and humoral immunity were induced by serial vaccination with DC/Tumor Fusion Cells and IL-12.	2-3 years
Secondary	Overall survival (OS) time	Assessed from this study start date to date of death of any cause. Patients will be censored at the time that they are last known to be alive (if withdrawn or lost to follow-up).	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months