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

NCT07170254 | Recruiting

• 1 other identifier: BD-HSIL-114001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High-grade Squamous Intraepithelial Lesions (HSIL)

Keywords

High-grade squamous intraepithelial lesions; HPV-16 infection; Gene Editing Therapy

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs) and serious adverse events (SAEs)

  All AEs and SAEs occurring during the study period (from informed consent signing to Week 36 post-BD114 intervention) were recorded and assessed according to the NCI-CTCAE v5.0 grading system, including their classification by System Organ Class (SOC), severity grade, number of affected Participants, and incidence rates. Gynecological AEs (beyond NCI-CTCAE v5.0 specifications) shall be evaluated by investigators for classification and severity grading according to current clinical guidelines/expert consensus.

  ~36 weeks

• Percentage of Participants with No Histologic Evidence of HSIL

  Cervical tissue biopsies obtained at Week 24 and Week 36 undergo histopathological evaluation, and judge the HSIL Clearance by complete regression or disappear of the original lesions, with clearance rates calculated per the following formula: Percentage of Participants with No Histologic Evidence of HSIL (%) = Number of Participants Achieving HSIL Clearance / Total number of Participants treated with BD114 ×100%

  Week 24, Week 36

Secondary Outcomes (8)

• Percentage of Participants with No Histologic Evidence of HSIL and No Evidence of HPV-16

  Week 24, Week 36

• Percentage of Participants with No Evidence of HPV-16

  Week 24, Week 36

• Percentage of Participants with No Evidence of HSIL or LSIL

  Week 36

• Percentage of Participants with No Evidence of HSIL or LSIL and No Evidence of HPV-16

  Week 36

• Changes in Serum Inflammatory Cytokine (IL-1/IL-6/TNF-α/IFN-γ) Levels Relative to Baseline

  Arm 1: at Day 2, Week 1, Week 2, Week 4, Week 12, Week 24, and Week 36. Arm 2: at Day 10, Day 15, Day 22, Day 36, Week 12, Week 24, and Week 36

Study Arms (2)

BD114 injection

EXPERIMENTAL

Subgroup 1: Low-dose (n=1) * Small lesions (≤5 mm\^2): BD114 injection, 0.2 mL * Large lesions (\>5 mm\^2): BD114 injection 0.4 mL Subgroup 2: High-dose (n=5) * Small lesions (≤5 mm\^2): BD114 injection, 0.3 mL * Large lesions (\>5 mm\^2): BD114 injection 0.6 mL

Genetic: BD114VLP, or BD114

BD114 gel

EXPERIMENTAL

Subgroup 1: Low-dose (n=1) * Small lesions (≤5 mm\^2): BD114 gel, 0.1 mL * Large lesions (\>5 mm\^2): BD114 gel, 0.2 mL Subgroup 2: High-dose (n=5) * Small lesions (≤5 mm\^2): BD114 gel, 0.2 mL * Large lesions (\>5 mm\^2): BD114 gel, 0.4 mL

Genetic: BD114VLP or BD114 plus Gel

Interventions

BD114VLP, or BD114 GENETIC

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.

BD114 injection

BD114VLP or BD114 plus Gel GENETIC

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) .

BD114 gel

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Shanghai BDgene Co., Ltd.: lead
• Obstetrics & Gynecology Hospital of Fudan University: collaborator

Study Sites (1)

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, 200090, China

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Interventions

Gels

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Fujun Li, M.D.

CONTACT

086-191 2131 1061; fujun.li@bdgene.cn

Long Sui, M.D.

CONTACT

086-138 0178 8118; suilong@sh163.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

CN (1)