Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
TVAX Biomedical's randomized phase 2/3 study of TVI-Brain-1 plus standard therapy versus standard therapy alone in newly diagnosed MGMT-unmethylated GBM is now active, not recruiting — enrolled and in follow-up. The design is a closed autologous loop: a vaccine built from the patient's resected tumor expands neoantigen-specific effector T cell precursors, which are harvested from blood, stimulated and expanded ex vivo, then reinfused. Reaching phase 2/3 in GBM places this among the more advanced neoantigen-directed adoptive T cell programs, with randomized, standard-of-care-controlled data as the bar.