Actively Recruiting
A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL
Led by Shanghai BDgene Co., Ltd. · Updated on 2025-09-12
12
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
S
Shanghai BDgene Co., Ltd.
Lead Sponsor
O
Obstetrics & Gynecology Hospital of Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 25 to 50 years, without childbearing demand
- Confirmed cervical HSIL (CIN3) by histopathology at screening or within 1 month prior
- Confirmed HPV-16 positive with no other high-risk HPV types by HPV test at screening or within 1 month prior
- Complete visibility of squamocolumnar junction and suspected HSIL lesions by colposcopy at screening or within 1 month prior
- No precancerous lesions or malignancy found by endocervical curettage
- Biopsy sampling of cervical lesions performed
- Visible residual cervical lesions after biopsy
- Willing to maintain abstinence or use highly effective contraception until Week 36, or partner has surgical sterilization
- Good compliance with study procedures as assessed by investigator
- Voluntary participation with signed informed consent
You will not qualify if you...
- Positive test for HIV, hepatitis B or C, or Treponema pallidum at screening
- Histopathological evidence of epithelial or glandular carcinoma or precancerous lesions in the endometrium at screening
- High-grade intraepithelial neoplasia or invasive carcinoma in vulva, vagina, or anus at screening
- HSIL partially located in cervical canal with incomplete colposcopic visualization
- Treatment for cervical HSIL within 4 weeks prior to screening
- History of any therapeutic HPV vaccine
- Family history or current history of malignant tumors
- Severe uncontrolled major organ diseases (e.g., heart attack, stroke, liver cirrhosis, severe kidney disease, diabetes, COPD, blood disorders, psychiatric disorders)
- Pregnant or lactating women
- Participation in another drug or device clinical trial at screening or within 3 months prior
- History of any gene or cell therapy
- Drug abuse or alcohol addiction affecting compliance
- Any other condition judged unsuitable for study participation by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China, 200090
Actively Recruiting
Research Team
F
Fujun Li, M.D.
CONTACT
L
Long Sui, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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