[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639236":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":58,"studyPopulation":51,"armGroups":59,"interventions":65,"overallOfficials":51,"centralContacts":71,"locations":77,"responsibleParty":93,"collaborators":51,"id":97,"slug":51,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":51,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":51,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":117,"whyStopped":51,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":51},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Dose limited toxicity (DLT)","DLT is defined as any of the predefined adverse events (AEs) related to KSVCBD occurring within 28 days after KSVCBD infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0).","Within 28 days post-infusion",{"measure":14,"description":15,"timeFrame":16},"Adverse events (AEs) and serious adverse events (SAEs)","Incidence and severity of AEs and SAEs","Within 24 months post-infusion",{"measure":18,"description":19,"timeFrame":16},"Adverse events of special interest (AESI)","AESI including grade ≥3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections",[21,24,27,30,33,36,39,42,45,48],{"measure":22,"description":23,"timeFrame":16},"ARR","Annualized relapse rate (ARR), Time to first relapse, and annualized hospitalization frequency after treatment.",{"measure":25,"description":26,"timeFrame":16},"Number of Active lesions","Change from baseline in the total number of active lesions on MRI after treatment;",{"measure":28,"description":29,"timeFrame":16},"EDSS score","Change from baseline in EDSS score",{"measure":31,"description":32,"timeFrame":16},"AQP4 antibody","Change from baseline in aquaporin-4 (AQP4) antibody level",{"measure":34,"description":35,"timeFrame":16},"Visual status","Change from baseline in visual acuity, visual field, and optical coherence tomography \\[OCT, including retinal nerve fiber layer (RNFL) and ganglion cell layer (GCL)\\] after treatment.",{"measure":37,"description":38,"timeFrame":16},"KSVCBD lentiviral particle concentration","KSVCBD lentiviral particle concentration in peripheral blood.",{"measure":40,"description":41,"timeFrame":16},"CAR-positive T cells","CAR-positive T cells in peripheral blood.",{"measure":43,"description":44,"timeFrame":16},"CAR gene copy number","CAR gene copy number in peripheral blood",{"measure":46,"description":47,"timeFrame":16},"Number of CD19-positive cells","Number of CD19-positive cells in peripheral blood.",{"measure":49,"description":50,"timeFrame":16},"Number of BCMA-positive cells","Number of BCMA-positive cells in peripheral blood",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":55,"observationalModel":51,"timePerspective":51,"maskingInfo":56},"NA","SINGLE_GROUP","TREATMENT",{"masking":57,"maskingDescription":51,"whoMasked":51},"NONE","KSVCBD-R103 is an open-label study in subjects with NMOSD. The dose-escalation will be conducted to evaluate the safety and preliminary efficacy of KSVCBD. This study consists of a screening period, a treatment period and a follow-up period. During treatment period, the subjects will receive single-dose of KSVCBD injection. The duration of participation for each subject will be approximately 104 weeks.",[60],{"label":61,"type":62,"description":51,"interventionNames":63},"AQP4-positive Neuromyelitis Optica Spectrum Disorders","EXPERIMENTAL",[64],"Biological: KSVCBD injection",[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":51},"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.",[61],[72],{"name":73,"role":74,"phone":75,"phoneExt":51,"email":76},"Shihui Wei, MD","CONTACT","+86 13910079431","weishihui706@hotmail.com",[78],{"facility":5,"status":51,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Beijing","Beijing Municipality","100853","China","CN",{"type":85,"coordinates":86},"Point",[87,88],116.39723,39.9075,{"lat":88,"lon":87},[91],{"name":92,"role":74,"phone":75,"phoneExt":51,"email":76},"shihui Wei, MD",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"PRINCIPAL_INVESTIGATOR","Shihui Wei","Chief Physician and Professor","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":107,"type":108},18,"ESTIMATED","INTERVENTIONAL",[111],"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",[114],"Neuromyelitis Optica Spectrum Disease (NMOSD)",[116],"Neuromyelitis Optica Spectrum Disorders","NOT_YET_RECRUITING","2026-05-12",{"date":120,"type":121},"2026-05-18","ACTUAL",{"date":123,"type":108},"2026-05-15",{"date":125,"type":108},"2029-03-31",{"name":5,"class":6},1]