NOT YET RECRUITING
NCT07714577
Investigator-Initiated Study of BBM-C101 Injection in Subjects With HPV16/18 Infection
This is a single-arm, single-center, open-label Investigator-Initiated Trial (IIT) designed to evaluate the safety and efficacy of BBM-C101 Injection in subjects with HPV16/18 infection and histopathologically confirmed ≤ Grade 2 CIN, VIN, VAIN or AIN via colposcopy or anoscopy, with a planned enrollment of 200 subjects. The study consists of three phases: a 4-week screening period, a 52-week treatment/follow-up period, and a 52-week long-term follow-up period. Safety will be assessed based on vital signs, physical examinations, laboratory tests, as well as the number and severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) occurring throughout the study.
Gender: All
Ages: 18 Years - Any
