A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL

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.