Phase II Study to Assess Safety and Effectiveness of ADCV01 Dendritic Cell Vaccine Added to Standard Treatment for Adults with Newly Diagnosed Primary Glioblastoma Multiforme

What this Trial Is About

This research aims to evaluate the safety and effectiveness of autologous dendritic cell vaccination ADCV01 as an additional treatment for patients newly diagnosed with primary glioblastoma multiforme GBM, a severe brain tumor with high mortality and limited survival even after standard therapies. The study focuses on patients with a specific immune profile characterized by low PD-1CD8 ratio, which may influence treatment response. This is a phase II, open-label, randomized trial designed to compare the add-on immunotherapy with conventional treatment alone. Participants will be divided into two groups one receiving the standard care of surgery, radiotherapy, and chemotherapy with Temozolomide TMZ, and the other receiving the same standard care plus 10 doses of ADCV01. ADCV01 is made from the patients own dendritic cells stimulated by their tumor antigens and administered via injections into lymph nodes at varying intervals over several months. The control group will receive only the conventional treatment. Both groups will be monitored closely, and if GBM recurs, treatments may shift to anti-angiogenic therapy Avastin. Throughout the study, patients will undergo regular tumor assessments using MRI scans and clinical evaluations based on established criteria for brain tumors. Researchers will measure progression-free survival at one year as the primary outcome, alongside safety and response evaluations. Additional assessments include blood tests, neurological exams, and monitoring of vital signs and immune markers. The total participation duration varies, with ongoing follow-up to assess treatment effects and disease progression until the studys end in late 2026.

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