eligibility_summary
Eligibility: consent, primary remission, MRI disease <1 cm³ within 4 weeks (central read), HLA‑A2+, adequate labs (Hgb>8, ANC>1000, Plt>100k, BUN<30, Cr<2, AST/ALT/ALP<2×ULN, PT/aPTT≤1.6× unless therapeutic), contraception if fertile, ≥1 positive DTH (>5 mm). Exclude: investigational/immunologic therapy, IDH‑mutant GBM, unsafe comorbidities, hepatitis B/C, prolonged steroids (>2 wks), acute infection ≤7 days, other active cancer <3 yrs, pregnant/nursing.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: ICT-107 is a personalized, autologous dendritic cell vaccine (cell-based immunotherapy). Patient-derived DCs are pulsed with six glioblastoma tumor‑associated antigen peptides and given intradermally to present HLA‑A2–restricted epitopes, priming antigen‑specific cytotoxic T lymphocytes (and helper T cells) to kill GBM cells expressing those antigens. Comparator is placebo (autologous monocyte‑enriched PBMC). All patients receive standard temozolomide (TMZ), an oral alkylating chemotherapy that methylates DNA (e.g., O6‑guanine), causing tumor cell death, efficacy is influenced by MGMT, used here for stratification. Cells/pathways targeted: dendritic cell antigen presentation (HLA‑A2/MHC I), activation of CD8+ T cells, recognition of GBM TAAs on tumor cells, DNA damage/repair axis (TMZ vs MGMT).