eligibility_summary
Eligible: women 18–60 with biopsy‑proven HPV‑16/18 cervical HSIL, normal/acceptable ECG, adequate blood/liver/kidney function, negative pregnancy test with contraception, able to consent/comply. Exclude: AIS/other high‑grade or invasive lesions, pregnancy/lactation, recent vaccines, HSIL therapy, or other trial, metal implants near deltoid, immunodeficiency/autoimmune, immunosuppression, or transplant, significant infection (HIV/syphilis/zoster), serious organ/cardiac disease, epilepsy on meds, other malignancy (limited exceptions), severe allergy, severe mental illness/substance abuse, unwilling contraception, investigator discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: NWRD08, a therapeutic DNA plasmid vaccine targeting HPV-16/18 in cervical HSIL, delivered intramuscularly with electroporation (TERESA device) to enhance plasmid uptake and antigen expression. Mechanism of action: host cells express HPV antigens from the plasmid, which are presented via MHC I/II to induce robust HPV-specific cellular immunity—primarily CD8+ cytotoxic and CD4+ helper T-cell responses—aimed at clearing HPV-16/18–infected dysplastic cervical epithelial cells. Cells/pathways targeted: HPV-16/18–positive cervical epithelial cells, antigen presentation pathways and T-cell activation. Study design: Phase 1, single-arm dose escalation (1, 4, 8 mg) to determine the maximum tolerated dose.