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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04388033
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hong Shen, MD
Principal Investigator Affiliation	Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Unknown status
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Neoplasms, Nerve Tissue, Vaccines, Immunologic Factors

Additional Details

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.

Arms & Interventions

Arms

Experimental: Safety Evaluation Group

Basic treatment phase: The patients have surgery followed by concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days). Immunotherapy phase: Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. Fusion cells will be suspended in 0.5 mL normal saline and then injected intradermally close to a cervical lymph node. IL-12 will be injected subcutaneously at the same side at dose of 6ug twice for interval of one hour.

Interventions

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.

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310051

Site Contact

Hong Shen, MD

[email protected]

8613805730380

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China