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

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.