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This study aims to evaluate the safety, tolerability and preliminary efficacy of BD114, an instantaneous CRISPR/Cas9 gene editing therapy delivered as a virus-like particle (BD114VLP), for high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 infection. The product is given alone or together with a gel. Eligible participants are women aged 25 to 50 without childbearing plans who have histopathologically confirmed cervical HSIL (CIN3) and a positive HPV-16 test at screening or within the prior month.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Female, aged 25 to 50 years, without childbearing demand; 2. Confirmed histopathological evidence of cervical HSIL (CIN3) at the screening period or within 1 month prior to screening; 3. 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; 4. 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; 5. No evidence of precancerous lesions or malignancy by endocervical curettage (ECC) ; 6. The biopsy sampling of cervical lesions are performed; 7. Visible residual cervical lesions after screening biopsy; 8. Willing to maintain abstinence or use a highly effective contraceptive method (oral contraceptives, injections, implants, or barrier methods) for women of childbearing potential (WOCBP) from enrollment until Week 36, or her partner undergone surgical sterilization (e.g., vasectomy); 9. Good compliance to protocol-specified procedure in study duration assessed by investigator; 10. Voluntarily participating in the study and willing to provided signed informed consent. Exclusion Criteria: 1. 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; 2. Confirmed histopathologically epithelial carcinoma, glandular carcinoma or precancerous lesions in the endometrium at screening; 3. Confirmed histopathologically or macroscopically high-grade intraepithelial neoplasia or invasive carcinoma in the vulva, vagina or anus at screening; 4. HSIL with partial location in cervical canal and incomplete colposcopic visualization ; 5. Undergone the treatment for cervical HSIL within 4 weeks prior to screening; 6. Vaccination history of any therapeutic HPV vaccine; 7. Family history of malignancy, or a history/current presence of any malignant tumor; 8. Severe uncontrolled diseases of major organs, including but not limited to: acute myocardial infarction, stroke, liver cirrhosis, severe kidney disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), hematologic disorders, psychiatric disorders, etc; 9. Pregnant (a positive urine or serum pregnancy test) or lactating women; 10. Participating in another drug or device clinical trial at screening, or participated in one within 3 months prior to screening; 11. The history of any form of gene and/or cell therapy; 12. Drug abuse or alcohol addiction no compliance to protocol-specific procedure; 13. Any other condition unsuitable for participating this study judged by the investigator.