eligibility_summary
Adults (≥18) with histologically confirmed H3.1/3 K27M diffuse midline glioma (WHO IV), immunocompetent, KPS ≥60, CrCl ≥30 mL/min, tumor tissue available, no prior therapy except surgery, planned radiotherapy, able to consent, WOCBP negative pregnancy test + effective contraception, men use condoms. Exclude immunosuppression, prior non-surgical therapy, key lab abnormalities, active infection/TB/HIV/HBV/HCV, autoimmune/CV disease, transplants, recent cancer, hypersensitivity, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT04808245 (INTERCEPT-H3) is a phase I, single-arm trial in adults with H3K27M-mutant diffuse midline glioma. Interventions: (1) H3K27M long peptide vaccine (biologic) given s.c. to present the mutant histone H3 neoepitope and prime/expand tumor-specific CD4/CD8 T cells, (2) topical imiquimod 5% (small-molecule TLR7 agonist adjuvant) to activate dendritic cells and enhance antigen presentation, (3) atezolizumab (Tecentriq, anti–PD-L1 IgG1 monoclonal antibody, immune checkpoint inhibitor) i.v. after radiotherapy to block PD-1/PD-L1–mediated T-cell inhibition. Targets/pathways: H3K27M neoantigen on tumor cells, PD-L1/PD-1 axis on tumor and immune cells to reverse T-cell exhaustion, TLR7 on antigen-presenting cells, activation of neoepitope-specific T lymphocytes within the glioma microenvironment. Standard involved-field radiotherapy is given upfront.