eligibility_summary
Inclusion: Women 18–45 (A) or 18–55 (B), BMI≤30, CIN2/3 confirmed ≤12 wks, HPV16/18+, adequate labs, WOCBP contraception. Exclusion: AIS/invasive cancer or other high-grade anogenital lesions, severe vaccine allergy, active HSV, HIV/syphilis/HBV/HCV, major CV disease/QTcF≥470, recent major surgery, bleeding risk/anticoagulants, pregnant/lactating, steroids/immunosuppressed, recent cancer tx/blood/vaccines, prior therapeutic HPV vaccine, unresolved AEs, recent other trials, other serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm, open-label Phase 1/2 trial of RG002 in HPV16/18-associated CIN2/3. Intervention: RG002 is a biological mRNA therapeutic vaccine given intramuscularly (25/75/150 µg, three doses every 2 weeks). Mechanism: lipid-encapsulated mRNA directs host cells to express HPV16/18 antigens, enhancing dendritic-cell antigen presentation and inducing strong adaptive immunity—especially CD8+ cytotoxic and CD4+ helper T-cell responses—to clear HPV-infected dysplastic cervical epithelial cells and promote lesion regression. Targets: HPV16/18 viral antigens in cervical epithelial cells, antigen presentation pathways (MHC I/II) and T-cell activation/cytolytic pathways.