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Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients

NCT04115761 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-09-19

No results posted yet for this study

Summary

This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme

Conditions

Interventions

BIOLOGICAL

autologous dendritic cells

The total 10 doses (1 mL/dose; 2±0.5 × 10\^7 cell/dose) of ADCV01 will be administered to patients assigned to the investigational group. The ADCV01 will be administered to the bilateral subaxillary subcutaneous regional lymph nodes (half of volume about 0.5 mL of ADCV01) once weekly for the first 4 doses, and the following 2 treatments will be administered bi-weekly. The last 4 treatments will be administered every 4 weeks.

Sponsors & Collaborators

  • Ever Supreme Bio Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wen-Liang Huang · Ever-Supreme Biotechnology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT04115761 on ClinicalTrials.gov