[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606031":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Shanghai BDgene Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BD114 injection","EXPERIMENTAL","Subgroup 1: Low-dose (n=1)\n\n* Small lesions (≤5 mm\\^2): BD114 injection, 0.2 mL\n* Large lesions (\\>5 mm\\^2): BD114 injection 0.4 mL\n\nSubgroup 2: High-dose (n=5)\n\n* Small lesions (≤5 mm\\^2): BD114 injection, 0.3 mL\n* Large lesions (\\>5 mm\\^2): BD114 injection 0.6 mL",[13],"Genetic: BD114VLP, or BD114",{"label":15,"type":10,"description":16,"interventionNames":17},"BD114 gel","Subgroup 1: Low-dose (n=1)\n\n* Small lesions (≤5 mm\\^2): BD114 gel, 0.1 mL\n* Large lesions (\\>5 mm\\^2): BD114 gel, 0.2 mL\n\nSubgroup 2: High-dose (n=5)\n\n* Small lesions (≤5 mm\\^2): BD114 gel, 0.2 mL\n* Large lesions (\\>5 mm\\^2): BD114 gel, 0.4 mL",[18],"Genetic: BD114VLP or BD114 plus Gel",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"GENETIC","BD114VLP, or BD114","CRISPR\u002FCas9 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\u002FCas9 ribonucleoprotein complex (RNP). It works to knock out or knock down HPV-16 E6\u002FE7 genes integrated in HSIL cell genome resulting to lesion clearness or regression.\n\nA single dosing BD114 injection by topical intraepithelial injection of HSIL lesion.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"BD114VLP or BD114 plus Gel","Genetic: BD114VLP or BD114 plus Gel CRISPR\u002FCas9 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\u002FCas9 ribonucleoprotein complex (RNP). It works to knock out or knock down HPV-16 E6\u002FE7 genes integrated in HSIL cell genome resulting to lesion clearness or regression.\n\nMultiple 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) .",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Fujun Li, M.D.","CONTACT","086-191 2131 1061","fujun.li@bdgene.cn",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Long Sui, M.D.","086-138 0178 8118","suilong@sh163.net",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Obstetrics & Gynecology Hospital of Fudan University","RECRUITING","Shanghai","200090","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55,56,57,59],{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},{"name":25,"role":33,"phone":25,"phoneExt":25,"email":39},{"name":37,"role":58,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Limei Chen, M.D.","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[65],{"name":42,"class":66},"OTHER","100606031","a-clinical-study-on-the-evaluation-of-bd114-for-the-treatment-hpv-16-related-cervical-hsil-100606031",false,"NCT07170254","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\u002FCas9 Gene Editing Therapy For Treating Chinese Patients With HPV-16-Related High-Grade Squamous Intraepithelial Lesions (HSIL)","Inclusion Criteria:\n\n1. Female, aged 25 to 50 years, without childbearing demand;\n2. Confirmed histopathological evidence of cervical HSIL (CIN3) at the screening period or within 1 month prior to screening;\n3. 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;\n4. Complete visibility of both the squamocolumnar junction (SCJ Types 1\u002F2) 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;\n5. No evidence of precancerous lesions or malignancy by endocervical curettage (ECC) ;\n6. The biopsy sampling of cervical lesions are performed;\n7. Visible residual cervical lesions after screening biopsy;\n8. 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);\n9. Good compliance to protocol-specified procedure in study duration assessed by investigator;\n10. Voluntarily participating in the study and willing to provided signed informed consent.\n\nExclusion Criteria:\n\n1. 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;\n2. Confirmed histopathologically epithelial carcinoma, glandular carcinoma or precancerous lesions in the endometrium at screening;\n3. Confirmed histopathologically or macroscopically high-grade intraepithelial neoplasia or invasive carcinoma in the vulva, vagina or anus at screening;\n4. HSIL with partial location in cervical canal and incomplete colposcopic visualization ;\n5. Undergone the treatment for cervical HSIL within 4 weeks prior to screening;\n6. Vaccination history of any therapeutic HPV vaccine;\n7. Family history of malignancy, or a history\u002Fcurrent presence of any malignant tumor;\n8. 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;\n9. Pregnant (a positive urine or serum pregnancy test) or lactating women;\n10. Participating in another drug or device clinical trial at screening, or participated in one within 3 months prior to screening;\n11. The history of any form of gene and\u002For cell therapy;\n12. Drug abuse or alcohol addiction no compliance to protocol-specific procedure;\n13. Any other condition unsuitable for participating this study judged by the investigator.","FEMALE","25 Years","50 Years",{"count":78,"type":79},12,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study is intented to evaluate the safety, and tolerability and preliminary efficacy of Instantaneous CRISPR\u002FCas9 Gene Editing Therapy (BD114 virus-like particle, also BD114) for the treatment of high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 infection.",[85],"High-grade Squamous Intraepithelial Lesions (HSIL)",[87,88,89],"High-grade squamous intraepithelial lesions","HPV-16 infection","Gene Editing Therapy","2025-09-05",{"date":92,"type":93},"2025-09-12","ACTUAL",{"date":95,"type":79},"2025-09",{"date":97,"type":79},"2026-12",{"name":5,"class":6},1]