eligibility_summary
Two cohorts. A: women 18–60, HPV16+, cervical/vaginal/vulvar HSIL or LSIL (persistent >6 mo or HSIL with satisfactory colposcopy), contraception/negative pregnancy test, consent. B: women ≥18 with HPV16-related recurrent/metastatic cervical cancer after ≥1 line or intolerant/no standard, measurable lesion, ECOG 0–1, adequate organs, ≥3-mo survival. Exclusions: recent vaccines/other trials, immunosuppression/autoimmune, active HBV/HCV/HIV/TB, severe allergy, major organ/CNS disease, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: NWRD09, an HPV‑16–targeted therapeutic mRNA vaccine (biological, intramuscular). Mechanism: delivers mRNA encoding HPV‑16 antigens to host cells, driving intracellular antigen expression, MHC I/II presentation, dendritic cell activation, and robust HPV‑16–specific T‑cell immunity (CD8+ cytotoxic and CD4+ helper responses) to eliminate HPV‑16–infected dysplastic and cancer cells. Targets: antigen‑presenting cells (especially dendritic cells) for uptake/translation, adaptive immune pathways (TCR/MHC antigen presentation, CTL‑mediated tumor cell killing, Th1 cytokines like IFN‑γ), tumor cells expressing HPV‑16 antigens in cervical, vaginal, and vulvar intraepithelial neoplasia and advanced cervical cancer. Design: single‑arm, two‑cohort, 3+3 dose escalation to define safety/MTD and preliminary efficacy.