A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-50
SponsorShanghai BDgene Co., Ltd.
About this trial
This study is intented to evaluate the safety, and tolerability and preliminary efficacy of Instantaneous CRISPR/Cas9 Gene Editing Therapy (BD114 virus-like particle, also BD114) for the treatment of high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 infection.
Eligibility criteria
Qualifiers
Female, aged 25 to 50 years, without childbearing demand;
Confirmed histopathological evidence of cervical HSIL (CIN3) at the screening period or within 1 month prior to screening;
Confirmed cervical HPV-16 positive by HPV test during the screening period or within 1 month prior to screening, without other high-risk HPV types detected;
Complete visibility of both the squamocolumnar junction (SCJ Types 1/2) and the upper margin of acetate-white epithelium or suspected HSIL lesions under colposcopy examine during the screening period or within 1 month prior to screening;
Disqualifiers
Positive detection of antibodies or viral test of human immunodeficiency virus (HIV), or hepatitis B virus (HBV), or hepatitis C virus (HCV), or Treponema pallidum (TP) at screening;
Confirmed histopathologically epithelial carcinoma, glandular carcinoma or precancerous lesions in the endometrium at screening;
Confirmed histopathologically or macroscopically high-grade intraepithelial neoplasia or invasive carcinoma in the vulva, vagina or anus at screening;
HSIL with partial location in cervical canal and incomplete colposcopic visualization ;
Trial design
Treatments tested in this trial
- BD114VLP, or BD114
- BD114VLP or BD114 plus Gel
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shanghai BDgene Co., Ltd.
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Source ClinicalTrials.gov