eligibility_summary
Eligibility: Tumor collection - adults >18 with presumptive primary GBM, planned resection, consent for tumor/blood and leukapheresis. Randomization - confirmed GBM, AIVITA cell line and sufficient monocytes, stratified by age, KPS, MGMT, IDH, planning RT/TMZ, consent. Exclude: prior glial tumor, autoimmune/immunodeficiency, life-threatening disease/cancer, GM-CSF allergy, for randomization: active infection, cardiac disease needing treatment, pregnant, other trial, KPS<70, or failed collection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: AV-GBM-1, a therapeutic autologous dendritic cell (DC) vaccine (biological, cellular immunotherapy) made from patient monocytes and loaded ex vivo with autologous GBM tumor antigens, given with GM-CSF. Control: autologous monocytes + GM-CSF (placebo comparator). Mechanism of action: DCs present patient-specific GBM antigens via MHC I/II to activate tumor-specific CD8+ cytotoxic and CD4+ helper T cells, driving a polyclonal antitumor immune response, GM-CSF enhances APC recruitment and maturation. Cells/pathways targeted: dendritic cells and T cells (antigen presentation, T-cell priming, effector cytotoxicity), myeloid/APC pathways via CSF2 (GM-CSF), and GBM tumor cells expressing the patient’s antigen repertoire. Standard care (surgery + RT/temozolomide, adjuvant TMZ ± TTFields/bevacizumab) is given in both arms.