BD114 CRISPR/Cas9 gene‑editing treatment for HPV‑16 cervical HSIL
An Open-Label, Two-Arm, Non-Randomized Clinical Study On The Safety And Efficacy Of Instantaneous CRISPR/Cas9 Gene Editing Therapy For Treating Chinese Patients With HPV-16-Related High-Grade Squamous Intraepithelial Lesions (HSIL)
This trial will test a single‑dose CRISPR/Cas9 product called BD114, given either as an intraepithelial injection or as a topical gel, in women aged 25–50 with HPV‑16–related high‑grade cervical lesions (HSIL).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 25 Years to 50 Years |
| Sex | Female |
| Sponsor | Shanghai BDgene Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07170254 on ClinicalTrials.gov |
What this trial studies
This open‑label, non‑randomized, two‑arm study will enroll 12 women with biopsy‑confirmed HPV‑16–related cervical HSIL and deliver a single dose of BD114 either by intraepithelial injection or topical gel. Each arm contains one low‑dose participant and five high‑dose participants to explore safety and preliminary activity across delivery methods. Participants are followed for about 40 weeks with monitoring for treatment‑emergent adverse events, measurement of BD114 components for pharmacokinetics, histologic lesion regression, and virologic HPV‑16 clearance. The study is exploratory and not powered for definitive efficacy, focusing on tolerability and biological signals to guide future trials.
Who should consider this trial
Good fit: Women aged 25–50 with biopsy‑confirmed cervical HSIL (CIN3), confirmed HPV‑16 infection only, fully visible lesions and squamocolumnar junction, no evidence of invasive cancer, and who agree to avoid pregnancy during the study.
Not a fit: Patients with other high‑risk HPV types, evidence of invasive cancer, lesions that are not fully visible, pregnant women, or those requiring immediate standard surgical treatment are unlikely to benefit from this experimental single‑dose approach.
Why it matters
Potential benefit: If successful, BD114 could provide a targeted, non‑surgical option to clear HPV‑16 infection and reverse high‑grade cervical lesions.
How similar studies have performed: CRISPR‑based antiviral approaches have shown encouraging preclinical results, but human clinical evidence for gene‑editing treatment of HPV lesions is very limited and remains largely experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Obstetrics & Gynecology Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Fujun Li, M.D.
- Email: fujun.li@bdgene.cn
- Phone: 086-191 2131 1061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.