A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL (NCT07170254) | Clinical Trial Compass
RecruitingNot Applicable
A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL
China12 participantsStarted 2025-09
Plain-language summary
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.
Who can participate
Age range25 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. 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;
✓. No evidence of precancerous lesions or malignancy by endocervical curettage (ECC) ;
✓. The biopsy sampling of cervical lesions are performed;
✓. Visible residual cervical lesions after screening biopsy;
✓. 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);
Exclusion criteria
✕. 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;
What they're measuring
1
Adverse events (AEs) and serious adverse events (SAEs)
Timeframe: ~36 weeks
2
Percentage of Participants with No Histologic Evidence of HSIL
✕. 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 ;
✕. Undergone the treatment for cervical HSIL within 4 weeks prior to screening;
✕. Vaccination history of any therapeutic HPV vaccine;
✕. Family history of malignancy, or a history/current presence of any malignant tumor;
✕. 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;