[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618411":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":102,"collaborators":20,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":20,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":20,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Nanjing Legend Biotech Co.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Chimeric antigen receptor T cells (LUCAR-G79D)","EXPERIMENTAL","Each subject will be given a single-dose LUCAR-G79D cells infusion at each dose level.",[13],"Biological: LUCAR-G79D T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","LUCAR-G79D T cells","Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.",[9],null,[22,41,56,70,84],{"facility":23,"status":24,"city":25,"state":26,"zip":20,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"The Third The People's Hospital of Bengbu","RECRUITING","Bengbu","Anhui","China","CN",{"type":30,"coordinates":31},"Point",[32,33],117.36083,32.94083,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"Hanwei Wang","CONTACT","860552-3281550","whw2139@sina.com",{"facility":42,"status":43,"city":44,"state":45,"zip":20,"country":27,"countryCode":28,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"Nanfang Hospital","NOT_YET_RECRUITING","Guangzhou","Guangdong",{"type":30,"coordinates":47},[48,49],113.25,23.11667,{"lat":49,"lon":48},[52],{"name":53,"role":38,"phone":54,"phoneExt":20,"email":55},"Qin Huang","86020-61641114","qinzihp@foxmail.com",{"facility":57,"status":43,"city":58,"state":59,"zip":20,"country":27,"countryCode":28,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Xiangya Hospital of Central South University","Changsha","Hunan",{"type":30,"coordinates":61},[62,63],112.97087,28.19874,{"lat":63,"lon":62},[66],{"name":67,"role":38,"phone":68,"phoneExt":20,"email":69},"Hongjun Zhao","860731-84327100","hongjunzhao2015@sina.com",{"facility":71,"status":24,"city":72,"state":73,"zip":20,"country":27,"countryCode":28,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"The Affiliated Hospital of Xuzhou Medical University","Xuzhou","Jiangsu",{"type":30,"coordinates":75},[76,77],117.28386,34.20442,{"lat":77,"lon":76},[80],{"name":81,"role":38,"phone":82,"phoneExt":20,"email":83},"Dongmei Zhou","860516-85805991","13813283017@163.com",{"facility":85,"status":43,"city":86,"state":87,"zip":20,"country":27,"countryCode":28,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":30,"coordinates":89},[90,91],115.85306,28.68396,{"lat":91,"lon":90},[94,98],{"name":95,"role":38,"phone":96,"phoneExt":20,"email":97},"Rui Wu","860791-88693035","tcmclinic@163.com",{"name":99,"role":38,"phone":100,"phoneExt":20,"email":101},"Fei Li","860791-88692517","ncyf.lifei@outlook.com",{"type":103,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100618411","phase-1-a-study-of-lucar-g79d-in-subjects-with-relapsedrefractory-systemic-lupus-erythematosus-rr-sle-and-idiopathic-inflammatory-myopathies-rr-iim-100618411",false,"NCT07331272","A Study of LUCAR-G79D in Subjects With Relapsed\u002FRefractory Systemic Lupus Erythematosus (r\u002Fr SLE) and Idiopathic Inflammatory Myopathies (r\u002Fr IIM)","An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79D in Subjects With Relapsed\u002FRefractory Systemic Lupus Erythematosus (r\u002Fr SLE) and Idiopathic Inflammatory Myopathies (r\u002Fr IIM)","Inclusion Criteria:\n\n1. Subjects voluntary agreement to provide written informed consent.\n2. Aged 18 to 70 years, either sex.\n3. Adequate organ function meet screening criteria.\n4. Positive test for cluster of differentiation antigen 19 (CD19).\n\nSLE:\n\n* Have been diagnosed of 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\nIIM:\n\n* Have been diagnosed of IIM before screening.\n* Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.\n* Fulfill relapsed\u002Frefractory IIM conditions.\n\nExclusion Criteria:\n\n1. Active infections such as hepatitis and tuberculosis.\n2. Other autoimmune diseases.\n3. Serious underlying diseases such as tumor, uncontrolled diabetes.\n4. Female subjects who were pregnant, breastfeeding.\n5. Those with a history of major organ transplantation.","ALL","18 Years","70 Years",{"count":115,"type":116},38,"ESTIMATED","INTERVENTIONAL",[119],"PHASE1","This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r\u002Fr SLE and r\u002Fr IIM.",[122,123],"Systemic Lupus Erythematosus (SLE)","Idiopathic Inflammatory Myopathies(IIM)","2026-01-29",{"date":126,"type":127},"2026-02-02","ACTUAL",{"date":124,"type":127},{"date":130,"type":116},"2030-01-31",{"name":5,"class":6},5]