eligibility_summary
Adults (>=18) with newly diagnosed WHO grade IV GBM after gross/near-total resection (<=3 cm2 residual), planned SOC RT+TMZ, KPS >=70, >=3-mo life expectancy, consent, adequate renal/hepatic/marrow function, agree to contraception. Exclude: other trials, implants/metal, pregnancy/breastfeeding, brainstem/spinal/multifocal/leptomeningeal disease, ICP, HIV, other malignancy, cardiac/neuro issues, syncope, dexamethasone, IM/blood-draw contraindications or site/electroporation limits, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: ITI-1001, a multi-antigen DNA vaccine (nucleic acid immunotherapy) delivered intramuscularly with electroporation, co-administered with tetanus toxoid. Composition/mechanism: two plasmids encoding CMV antigens—IE-1+pp65 (fusion) and gB—each fused to LAMP1 to route antigen to endo/lysosomes, enhancing MHC class II presentation and CD4+ T-helper priming, with cross-presentation to MHC I to drive cytotoxic CD8+ T cells. Intended effect: elicit strong CMV-specific cellular immunity to recognize and kill CMV-expressing GBM cells, Td toxoid provides recall CD4+ help. Cells/pathways targeted: dendritic cell antigen processing (LAMP1/lysosome), MHC II and I antigen presentation, activation of CD4+ Th1 and CD8+ CTLs in the tumor microenvironment.