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New treatment option for High-grade Squamous Intraepithelial Lesions (HSIL)
Official title A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL
ClinicalTrials.gov ID: NCT07170254
What this study is testing
What is BD114VLP, or BD114?
BD114VLP, or BD114 is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for high-grade squamous intraepithelial lesions (hsil).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 50, women only
You may be able to join 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...
- Complete visibility of both the squamocolumnar junction (SCJ Types 1/2) and the upper margin of acetate-white epithelium or suspected HSIL lesions...
- No evidence of precancerous lesions or malignancy by endocervical curettage (ECC) ;
You likely can't join if
- Positive detection of antibodies or viral test of human immunodeficiency virus (HIV), or hepatitis B virus (HBV), or hepatitis C virus (HCV), or...
- 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;
See the full eligibility criteria
- 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...
- 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...
- Good compliance to protocol-specified procedure in study duration assessed by investigator;
- Voluntarily participating in the study and willing to provided signed informed consent.
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.