A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related 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)
Shanghai BDgene Co., Ltd.
12 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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.
Exclusion Criteria13
- 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.
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Interventions
CRISPR/Cas9 instantaneous gene editing therapy, called BD114VLP (also BD114) which is a developing product of gene therapy from modified third-generation integrated defective lentivirus, can deliver gRNA/Cas9 ribonucleoprotein complex (RNP). It works to knock out or knock down HPV-16 E6/E7 genes integrated in HSIL cell genome resulting to lesion clearness or regression. A single dosing BD114 injection by topical intraepithelial injection of HSIL lesion.
Genetic: BD114VLP or BD114 plus Gel CRISPR/Cas9 instantaneous gene editing therapy, called BD114VLP (also BD114) which is a developing product of gene therapy from modified third-generation integrated defective lentivirus, can deliver gRNA/Cas9 ribonucleoprotein complex (RNP). It works to knock out or knock down HPV-16 E6/E7 genes integrated in HSIL cell genome resulting to lesion clearness or regression. Multiple dosing BD114 gel (BD114 injection :Gel, 1:1) topical application on HSIL, one time every other day, total 5 times (D0, D2, D4, D6, and D8) .
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07170254