A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL
Recruiting now · Not applicable
Conditions studied: High-grade Squamous Intraepithelial Lesions (HSIL)
In brief
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.
Key facts
- Study ID
- NCT07170254
- Run by
- Shanghai BDgene Co., Ltd.
- People needed
- 12
- Starts
- 2025-09-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-09-12
Who can join
Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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);
- Good compliance to protocol-specified procedure in study duration assessed by investigator;
- Voluntarily participating in the study and willing to provided signed informed consent.
You may not qualify if…
- 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 ;
- 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;
- Pregnant (a positive urine or serum pregnancy test) or lactating women;
- Participating in another drug or device clinical trial at screening, or participated in one within 3 months prior to screening;
- The history of any form of gene and/or cell therapy;
- Drug abuse or alcohol addiction no compliance to protocol-specific procedure;
- Any other condition unsuitable for participating this study judged by the investigator.
Where it is running
- Obstetrics & Gynecology Hospital of Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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