RecruitingPhase 2NCT04115761

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

A Phase II, Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Autologous Dendritic Cell Vaccination (ADCV01) As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients


Sponsor

Ever Supreme Bio Technology Co., Ltd.

Enrollment

24 participants

Start Date

Jun 6, 2019

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalised cancer vaccine called ADCV01 — made from the patient's own tumour cells — as an add-on treatment after standard surgery and chemoradiation for glioblastoma (GBM), the most aggressive type of brain tumour. **You may be eligible if...** - You are between 20 and 75 years old - You have been newly diagnosed with a single glioblastoma (WHO grade IV) that is not located in the brainstem or cerebellum - You are scheduled to have brain surgery to remove the tumour, and you agree to have tumour cells preserved to make the vaccine - You are reasonably functional (KPS score 70 or above) - Your kidney, liver, and blood functions meet required levels **You may NOT be eligible if...** - You have more than one brain tumour - Your tumour is in the brainstem or cerebellum - You have received any treatment inside the brain cavity (such as chemotherapy wafers) during surgery - Your organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALautologous 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.


Locations(3)

Taichung Veterans General Hospital

Taichung, Non-US, Taiwan

Chang-Gung Memorial Hospital at Lin-Ko

Taoyuan, Non-US, Taiwan

China Medical University Hospital

Taichung, Taiwan

View Full Details on ClinicalTrials.gov

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NCT04115761


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