[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639236":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AQP4-positive Neuromyelitis Optica Spectrum Disorders","EXPERIMENTAL",null,[13],"Biological: KSVCBD injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","KSVCBD injection","KSVCBD injection is a CD19\u002FBCMA-targeted in vivo-edited CAR-T cell injection. Three dose levels are predefined, and KSVCBD will be dose-escalated per the protocol-specified doses.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Shihui Wei, MD","CONTACT","+86 13910079431","weishihui706@hotmail.com",[27],{"facility":5,"status":11,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Beijing","Beijing Municipality","100853","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":24,"phoneExt":11,"email":25},"shihui Wei, MD",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Shihui Wei","Chief Physician and Professor","100639236","early-phase-1-the-safety-and-efficacy-of-ksvcbd-injection-in-neuromyelitis-optica-spectrum-disorder-100639236",false,"NCT07592754","The Safety and Efficacy of KSVCBD Injection in Neuromyelitis Optica Spectrum Disorder.","An Early Exploratory Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of Relapsed\u002FRefractory AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder.","Key Inclusion Criteria:\n\n1. Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4 antibodies.\n2. Documented evidence of at least 1 relapse within 12 months before signing the informed consent form.\n3. The Expanded Disability Status Scale (EDSS) score ≤ 8.\n4. Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period.\n5. Informed consent must be obtained from the patient or their legal representative, with a signed consent form must be provided.\n\nKey Exclusion Criteria:\n\n1. Viral infections: Known HIV, active HBV, or active HCV.\n2. Pregnant or breastfeeding women.\n3. History of other autoimmune diseases requiring immunosuppressive therapy.\n4. Use of any live vaccines against infectious disease within 6 weeks before enrollment.\n5. History of bone marrow\u002Fhematopoietic stem cell or solid organ transplantation.\n6. Patients deemed unsuitable for participation by the investigator.","ALL","18 Years","65 Years",{"count":57,"type":58},18,"ESTIMATED","INTERVENTIONAL",[61],"EARLY_PHASE1","KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This is a multi-center, single-arm, open-label, early exploratory clinical study. The objective of this study is to evaluate the safety and preliminary efficacy of KSVCBD injection in AQP4-positive Neuromyelitis Optica Spectrum Disorder",[64],"Neuromyelitis Optica Spectrum Disease (NMOSD)",[66],"Neuromyelitis Optica Spectrum Disorders","NOT_YET_RECRUITING","2026-05-12",{"date":70,"type":71},"2026-05-18","ACTUAL",{"date":73,"type":58},"2026-05-15",{"date":75,"type":58},"2029-03-31",{"name":5,"class":6},1]