eligibility_summary
Eligibility: Newly diagnosed MGMT-unmethylated GBM, adequate tumor for autologous vaccine (QC passed), normal renal/hepatic labs, off glucocorticoids ≥24h at vaccination/T-cell infusion, KPS>60, life expectancy >12 wks, Hgb>10 (transfusable), WBC>3k, Plt>100k (no transfusion), lymphs>1k. Exclude: other life‑threatening disease, active second cancer (except skin SCC/BCC), steroid‑dependent edema, active treated autoimmune disease, poor follow‑up/compliance, pregnancy or plan within 1 yr.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT05685004 tests TVI-Brain-1 plus standard chemoradiation vs standard therapy in newly diagnosed MGMT-unmethylated GBM. TVI-Brain-1 is a biological, autologous whole-tumor cell vaccine that primes/expands neoantigen-specific T cells, patients then undergo leukapheresis, ex vivo activation/expansion of autologous T cells, reinfusion post-chemoradiation, and low-dose IL-2 (cytokine) to support T-cell survival/proliferation. Standard therapy includes temozolomide (alkylating chemotherapy causing DNA methylation damage) and conformal radiotherapy (DNA double-strand breaks). Targets/pathways: patient-specific tumor neoantigens presented by APCs, expansion and cytotoxic function of CD8+ (and helper CD4+) T cells via TCR recognition, IL-2/IL-2R signaling (JAK/STAT) for T-cell expansion, tumor DNA-damage pathways engaged by temozolomide and radiation.