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RECRUITING

NCT07170254

A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL

Sponsor: Shanghai BDgene Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

FEMALE

Age Range

25 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09

Completion Date

2026-12

Last Updated

2025-09-12

Healthy Volunteers

Conditions

High-grade Squamous Intraepithelial Lesions (HSIL)

Interventions

GENETIC

BD114VLP, or BD114

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

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) .

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.

Locations (1)

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China