eligibility_summary
Ages 3–39. Stratum I: recurrent/progressive medulloblastoma, measurable, prior therapy incl RT unless <4y, protocol washouts. Stratum II: newly dx HGG (incl DMG), enroll ≤6 wks post standard RT. Stratum III: newly dx DIPG (radiographic or histologic). M+ allowed. KPS/LPS ≥50, adequate marrow/renal/hepatic, stable neuro, contraception/consent. Exclude pregnancy, active infection, HIV/HBV/HCV, immunosuppression, major organ disease, concomitant therapy/trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05096481 (Phase 2). Interventions and mechanisms: • PEP-CMV (biologic peptide vaccine): a synthetic long peptide (26 aa) from CMV pp65, formulated in Montanide ISA 51 (water-in-oil adjuvant). Designed for broad MHC I/II presentation to induce CMV-specific CD8+ cytotoxic T cells, CD4+ helper T cells, and antibodies, Montanide creates a depot and enhances DC activation. • Tetanus-diphtheria vaccine (biologic): booster plus low-dose preconditioning to recruit tetanus-specific CD4+ recall T cells and license local dendritic cells, improving priming to PEP-CMV. • Temozolomide (small-molecule alkylating chemotherapy): methylates DNA (O6-guanine), causing tumor cell death. Targets/cells/pathways: CMV pp65 antigen on tumor-associated cells, antigen-presenting cells/dendritic cells, MHC class I and II pathways, CD8+ CTLs, CD4+ T helper cells, and B-cell/antibody responses.