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.
Inclusion Criteria:
4.Screening electrocardiogram shows normal findings or no clinically significant abnormalities as judged by the investigator; 5.Fertile eligible participants must agree to use reliable contraceptive methods together with their partners during the trial and for at least 1 year after the last administration (hormonal contraceptives, barrier methods, or abstinence); female participants of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment;
Exclusion Criteria:
Evaluation of the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesion(HSIL)
Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+
Study of FluBHPVE6E7 in HPV-16 Infected Women
An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3)
A Phase II Clinical Trial Evaluating the Efficacy and Safety of SYS6026 Injection in Participants With HPV16 or 18-related High-grade Cervical Squamous Intraepithelial Lesions
Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
Phase I Clinical Trial of a Candidate HPV Vaccine
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3