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

STATUS

Recruiting
participants needed

10
sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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Updated on 19 February 2024

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white blood cell count

ejection fraction

temozolomide

glioblastoma multiforme

blood cell count

glioma

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-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.

Details

Condition	Neuroectodermal Tumor, neurectoderma, biological response modifier, Cancer, Glioma, Glioblastoma Multiforme, Glioblastoma Multiforme, Gliomatosis cerebri, Vaccines, Vaccines, Neoplasms, Nerve Tissue, Germ cell tumor, neurectoderma
Age	18years - 75years
Treatment	Temozolomide, Dendritic Cell/Tumor Fusion Vaccine, Interleukin-12
Clinical Study Identifier	NCT04388033
Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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