[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-myasthenia-gravisrr-ms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-myasthenia-gravisrr-ms":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},44,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"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)",[32],"Relapsed\u002FRefractory autoimmune diseases","NOT_YET_RECRUITING","2026-05-07",{"date":36,"type":37},"2026-05-13","ACTUAL",{"date":39,"type":21},"2026-04-20",{"date":41,"type":21},"2041-09-20",{"name":43,"class":44},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",5]