[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638272":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":98,"collaborators":100,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":19,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":19,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":128,"whyStopped":19,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LVIVO-TaVec400 product","EXPERIMENTAL","The dose escalation stage includes 4 dose level: DL1，DL2，DL3， DL4.",[13],"Biological: LVIVO-TaVec400 product",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Each subject will be given a single-dose LVIVO-TaVec400 via intravenous infusion.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Qiubai Li","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Qiubai Li, Professor","CONTACT","+86-27-85726808 Ext. 027","qiubaili@hust.edu.cn",{"name":31,"role":27,"phone":19,"phoneExt":19,"email":32},"Xiangxue Meng","xiangxue.meng@legendbiotech.cn",[34,51,65,73,84],{"facility":35,"status":19,"city":36,"state":37,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The First Affiliated Hospital of Anhui Medical University","Hefei","Anhui","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.28083,31.86389,{"lat":44,"lon":43},[47],{"name":48,"role":27,"phone":49,"phoneExt":19,"email":50},"Shengqian Xu","+86-0551-2922114","xsqian-1112@163.com",{"facility":52,"status":19,"city":53,"state":54,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Beijing Tiantan Hospital, Capital Medical University","Beijing","Beijing Municipality",{"type":41,"coordinates":56},[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61],{"name":62,"role":27,"phone":63,"phoneExt":19,"email":64},"Decai Tian","+86-010-59978585","decaitian@163.com",{"facility":52,"status":19,"city":53,"state":54,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},{"type":41,"coordinates":67},[57,58],{"lat":58,"lon":57},[70],{"name":71,"role":27,"phone":63,"phoneExt":19,"email":72},"Wei Zhou","zw2pumch@126.com",{"facility":74,"status":19,"city":75,"state":76,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","Hubei",{"type":41,"coordinates":78},[79,80],114.26667,30.58333,{"lat":80,"lon":79},[83],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},{"facility":85,"status":19,"city":86,"state":87,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Shanxi Bethune Hospital","Taiyuan","Shanxi",{"type":41,"coordinates":89},[90,91],112.56028,37.86944,{"lat":91,"lon":90},[94],{"name":95,"role":27,"phone":96,"phoneExt":19,"email":97},"Liyun Zhang","+86-0351-8379573","1315710223@qq.com",{"type":23,"investigatorFullName":22,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital",[101],{"name":102,"class":103},"Nanjing Legend Biotech Co.","INDUSTRY","100638272","early-phase-1-a-clinical-study-to-evaluate-lvivo-tavec400-for-the-treatment-of-relapsedrefractory-autoimmune-diseases-100638272",false,"NCT07583030","A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the LVIVO-TaVec400 in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects voluntarily participate in clinical studies.\n* Age 18-65 years.\n* Adequate organ function at screening.\n* Clinical laboratory values meet criteria at screening visit.\n\n  r\u002Fr SLE:\n* Patients meet the 2019 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) OR 2012 Systemic lupus international collaborating clinics (SLICC) classification criteria for SLE at least 6 months before screening.\n* At screening, antinuclear antibody, and\u002For anti-dsDNA antibody, and\u002For anti-Smith antibody should be positive.\n* Fulfill relapsed\u002Frefractory SLE conditions.\n\n  r\u002Fr IgG4-RD：\n* Patients meet the 2019 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for IgG4-RD.\n* Fulfill relapsed\u002Frefractory IgG4-RD conditions.\n* Patients have active disease: IgG4-RD Response Index (RI) ≥2.\n\nProgressive MS：\n\n* Diagnosis of MS according to 2017 revised McDonald criteria.\n* Progressive MS according to clinical course criteria revised in 2013.\n* Presence of Cerebrospinal fluid (CSF) oligoclonal bands (OCBs) or elevated IgG Index at screening.\n\n  r\u002Fr MG：\n* Diagnosis of MG.\n* Myasthenia Gravis Foundation of America (MGFA) Class II-IV.\n* Positive AChR-IgG or MuSK-IgG at screening.\n* Fulfill refractory MG conditions.\n\nExclusion Criteria:\n\n* Active infections such as hepatitis and tuberculosis.\n* Coexist other autoimmune or inflammatory diseases.\n* Severe underlying diseases such as tumor, uncontrolled diabetes and severe heart diseases.\n* Female subjects who are pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LVIVO-TaVec400 treatment.","ALL","18 Years","65 Years",{"count":115,"type":116},44,"ESTIMATED","INTERVENTIONAL",[119],"EARLY_PHASE1","This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed\u002Frefractory autoimmune diseases.",[122,123,124,125],"Relapsed\u002FRefractory Systemic Lupus Erythematosus (r\u002Fr SLE)","Relapsed\u002FRefractory IgG4-Related Disease (r\u002Fr IgG4-RD)","Progressive Multiple Sclerosis (PMS)","Relapsed\u002FRefractory Myasthenia Gravis(r\u002Fr MS)",[127],"Relapsed\u002FRefractory autoimmune diseases","NOT_YET_RECRUITING","2026-05-07",{"date":131,"type":132},"2026-05-13","ACTUAL",{"date":134,"type":116},"2026-04-20",{"date":136,"type":116},"2041-09-20",{"name":5,"class":6},5]