[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638272":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":57,"studyPopulation":50,"armGroups":58,"interventions":65,"overallOfficials":70,"centralContacts":74,"locations":83,"responsibleParty":148,"collaborators":150,"id":154,"slug":50,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":50,"eligibilityCriteria":159,"healthyVolunteers":155,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":50,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":175,"overallStatus":177,"whyStopped":50,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":33,"otherOutcomes":50},[9,13,17,21,24,27,29],{"measure":10,"description":11,"timeFrame":12},"The incidence of Dose-limiting toxicity (DLT)","DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which has a causal relationship with the treatment and will limit the dose escalation.","28 days after LVIVO-TaVec400 infusion (Day 1)",{"measure":14,"description":15,"timeFrame":16},"The incidence, severity of Adverse events (AEs)","An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.","Minimum 13 weeks after LVIVO-TaVec400 infusion (Day 1)",{"measure":18,"description":19,"timeFrame":20},"The incidence, severity of Treatment-related Adverse event (TRAE)","An treatment-related adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which has a causal relationship with the treatment.","Maximum 15 years after LVIVO-TaVec400 infusion (Day 1)",{"measure":22,"description":22,"timeFrame":23},"Maximum concentration (Cmax) in peripheral blood","Maximun 5 years after LVIVO-TaVec400 infusion (Day 1)",{"measure":25,"description":25,"timeFrame":26},"Time of maximum concentration (Tmax) in peripheral blood","Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)",{"measure":28,"description":28,"timeFrame":26},"Area under the concentration-time curve (AUC) in peripheral blood",{"measure":30,"description":31,"timeFrame":32},"Recommended Dose regimen finding","Determine the Recommended Dose regimen established through dose exploratory.","Maximum 104 weeks after LVIVO-TaVec400 infusion (Day 1)",[34,38,41,44,47],{"measure":35,"description":36,"timeFrame":37},"Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline for r\u002Fr SLE subjects","The SLEDAI-2K scale is a cumulative index used to assess disease activity across 24 different disease descriptors in patients with SLE. A total score ranges between 0 and 105, with a higher score representing a more significant degree of disease activity.","Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)",{"measure":39,"description":40,"timeFrame":37},"Change in IgG4-RD Response Index (IgG4-RD RI) from baseline for r\u002Fr IgG4-RD subjects","The IgG4-RD scale is a cumulative index used to assess disease activity across 25 different disease descriptions in patients with IgG4-RD. A total score ranges between 0 and 75, with a higher score representing a more significant degree of disease activity.",{"measure":42,"description":43,"timeFrame":37},"Change in Expanded Disability Status Scale (EDSS) scores from baseline for PMS subjects.","The EDSS is a scoring system used to quantify and monitor the progression of physical disability in patients with multiple sclerosis. The total score ranges from 0 to 10, with higher scores representing a worse outcome.",{"measure":45,"description":46,"timeFrame":37},"Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores from baseline for r\u002Fr MG subjects.","The MG-ADL is a patient-reported tool that quantifies the severity of myasthenia gravis symptoms based on daily functions. The total score ranges from 0 to 24, with higher scores representing a worse functional status.",{"measure":48,"description":49,"timeFrame":37},"Change in Quantitative Myasthenia Gravis (QMG) scores from baseline for r\u002Fr MG subjects.","The QMG is a standard clinical tool used to quantify the severity of myasthenia gravis through objective muscle testing. The total score ranges from 0 to 39, with higher scores representing a worse clinical status.",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"NA","SINGLE_GROUP","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE","This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the LVIVO-TaVec400, an in vivo chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed\u002Frefractory autoimmune diseases. The subject who meets the defined eligibility criteria will follow the sequential stages: screening, treatment (LVIVO-TaVec400 infusion) and follow-up (Up to 15 years).",[59],{"label":60,"type":61,"description":62,"interventionNames":63},"LVIVO-TaVec400 product","EXPERIMENTAL","The dose escalation stage includes 4 dose level: DL1，DL2，DL3， DL4.",[64],"Biological: LVIVO-TaVec400 product",[66],{"type":67,"name":60,"description":68,"armGroupLabels":69,"otherNames":50},"BIOLOGICAL","Each subject will be given a single-dose LVIVO-TaVec400 via intravenous infusion.",[60],[71],{"name":72,"affiliation":5,"role":73},"Qiubai Li","PRINCIPAL_INVESTIGATOR",[75,80],{"name":76,"role":77,"phone":78,"phoneExt":50,"email":79},"Qiubai Li, Professor","CONTACT","+86-27-85726808 Ext. 027","qiubaili@hust.edu.cn",{"name":81,"role":77,"phone":50,"phoneExt":50,"email":82},"Xiangxue Meng","xiangxue.meng@legendbiotech.cn",[84,101,115,123,134],{"facility":85,"status":50,"city":86,"state":87,"zip":50,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"The First Affiliated Hospital of Anhui Medical University","Hefei","Anhui","China","CN",{"type":91,"coordinates":92},"Point",[93,94],117.28083,31.86389,{"lat":94,"lon":93},[97],{"name":98,"role":77,"phone":99,"phoneExt":50,"email":100},"Shengqian Xu","+86-0551-2922114","xsqian-1112@163.com",{"facility":102,"status":50,"city":103,"state":104,"zip":50,"country":88,"countryCode":89,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Beijing Tiantan Hospital, Capital Medical University","Beijing","Beijing Municipality",{"type":91,"coordinates":106},[107,108],116.39723,39.9075,{"lat":108,"lon":107},[111],{"name":112,"role":77,"phone":113,"phoneExt":50,"email":114},"Decai Tian","+86-010-59978585","decaitian@163.com",{"facility":102,"status":50,"city":103,"state":104,"zip":50,"country":88,"countryCode":89,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},{"type":91,"coordinates":117},[107,108],{"lat":108,"lon":107},[120],{"name":121,"role":77,"phone":113,"phoneExt":50,"email":122},"Wei Zhou","zw2pumch@126.com",{"facility":124,"status":50,"city":125,"state":126,"zip":50,"country":88,"countryCode":89,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","Hubei",{"type":91,"coordinates":128},[129,130],114.26667,30.58333,{"lat":130,"lon":129},[133],{"name":72,"role":77,"phone":78,"phoneExt":50,"email":79},{"facility":135,"status":50,"city":136,"state":137,"zip":50,"country":88,"countryCode":89,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Shanxi Bethune Hospital","Taiyuan","Shanxi",{"type":91,"coordinates":139},[140,141],112.56028,37.86944,{"lat":141,"lon":140},[144],{"name":145,"role":77,"phone":146,"phoneExt":50,"email":147},"Liyun Zhang","+86-0351-8379573","1315710223@qq.com",{"type":73,"investigatorFullName":72,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital",[151],{"name":152,"class":153},"Nanjing Legend Biotech Co.","INDUSTRY","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":164,"type":165},44,"ESTIMATED","INTERVENTIONAL",[168],"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.",[171,172,173,174],"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)",[176],"Relapsed\u002FRefractory autoimmune diseases","NOT_YET_RECRUITING","2026-05-07",{"date":180,"type":181},"2026-05-13","ACTUAL",{"date":183,"type":165},"2026-04-20",{"date":185,"type":165},"2041-09-20",{"name":5,"class":6},5]