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

NCT04388033 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-06-09

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Hangzhou Medical Biotechnology Co., Ltd

    collaborator UNKNOWN

  • CyTIX.Inc

    collaborator UNKNOWN

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Hong Shen, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388033 on ClinicalTrials.gov