eligibility_summary
Two cohorts. A: women 18–60, HPV16+, HSIL, satisfactory colposcopy. B: women ≥18 with HPV16‑related recurrent/metastatic cervical cancer after ≥2 lines/no standard, ECOG 0–1. Exclude (both): pregnancy, recent trial/vaccine, immunosuppression/immune disease/transplant, active infection, severe allergy. A adds: exclude AIS/invasive cancer, recent HSIL/LSIL therapy. B adds: curable CIS/non‑HPV cancer, CNS mets/effusions, unresolved toxicities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: NWRD09, an HPV‑16–targeted therapeutic mRNA vaccine (biologic) given intramuscularly in a single‑arm, 3+3 dose‑escalation trial with two cohorts (HPV‑16–related LSIL/HSIL of cervix/vagina/vulva, and recurrent/metastatic HPV‑16–related cervical cancer). Mechanism of action: the mRNA is taken up by host cells and translated into HPV‑16 antigens that are presented on MHC I/II, activating antigen‑presenting cells and priming HPV‑16–specific immunity—primarily cytotoxic CD8+ T cells with CD4+ T‑cell help—and potentially antibody responses. Target cells/pathways: HPV‑16–infected or transformed epithelial/tumor cells expressing viral antigens (oncoprotein‑driven), via antigen presentation and T‑cell–mediated cytotoxic pathways to eliminate HPV‑16–positive lesions and tumors.