[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618411":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":11,"armGroups":43,"interventions":50,"overallOfficials":11,"centralContacts":11,"locations":56,"responsibleParty":137,"collaborators":11,"id":139,"slug":11,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":11,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":11,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":11,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Nanjing Legend Biotech Co.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,15,17,19,21],{"measure":10,"description":11,"timeFrame":12},"Incidence, severity, and type of treatment-emergent adverse events (TEAEs)",null,"2 years after LUCAR-G79D infusion (Day 1)",{"measure":14,"description":11,"timeFrame":12},"Incidence of dose-limiting toxicity (DLT)",{"measure":16,"description":11,"timeFrame":12},"Maximum concentration (Cmax) in peripheral blood",{"measure":18,"description":11,"timeFrame":12},"Time of maximum concentration (Tmax) in peripheral blood",{"measure":20,"description":11,"timeFrame":12},"Area under the concentration-time curve (AUC) in peripheral blood",{"measure":22,"description":11,"timeFrame":12},"Recommended Dose regimen finding",[24,28,31,34],{"measure":25,"description":26,"timeFrame":27},"Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for r\u002Fr SLE subjects","SLEDAI-2K is a scale ranging from 0 to 105 points, with higher scores indicating stronger disease activity","52 weeks after LUCAR-G79D infusion (Day 1)",{"measure":29,"description":30,"timeFrame":27},"Change in manual muscle testing (MMT-8) scores from baseline up to 52 weeks for r\u002Fr IIM subjects","MMT-8 is a scale ranging from 0 to 80 points, with higher scores indicating greater preserved muscle strength",{"measure":32,"description":33,"timeFrame":27},"Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects","Including IgG、IgM、IgA、IgE",{"measure":35,"description":11,"timeFrame":27},"Changes from baseline in anti-drug antibody from baseline up to 52 weeks for all subjects",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"NA","SINGLE_GROUP","TREATMENT",{"masking":41,"maskingDescription":11,"whoMasked":11},"NONE","This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79D, a chimeric antigen receptor (CAR) -T cell therapy in subjects with r\u002Fr SLE and r\u002Fr IIM. Patients who meet the eligibility criteria will receive LUCAR-G79D infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79D infusion) and follow-up.",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"Chimeric antigen receptor T cells (LUCAR-G79D)","EXPERIMENTAL","Each subject will be given a single-dose LUCAR-G79D cells infusion at each dose level.",[49],"Biological: LUCAR-G79D T cells",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":11},"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.",[45],[57,76,91,105,119],{"facility":58,"status":59,"city":60,"state":61,"zip":11,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"The Third The People's Hospital of Bengbu","RECRUITING","Bengbu","Anhui","China","CN",{"type":65,"coordinates":66},"Point",[67,68],117.36083,32.94083,{"lat":68,"lon":67},[71],{"name":72,"role":73,"phone":74,"phoneExt":11,"email":75},"Hanwei Wang","CONTACT","860552-3281550","whw2139@sina.com",{"facility":77,"status":78,"city":79,"state":80,"zip":11,"country":62,"countryCode":63,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Nanfang Hospital","NOT_YET_RECRUITING","Guangzhou","Guangdong",{"type":65,"coordinates":82},[83,84],113.25,23.11667,{"lat":84,"lon":83},[87],{"name":88,"role":73,"phone":89,"phoneExt":11,"email":90},"Qin Huang","86020-61641114","qinzihp@foxmail.com",{"facility":92,"status":78,"city":93,"state":94,"zip":11,"country":62,"countryCode":63,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Xiangya Hospital of Central South University","Changsha","Hunan",{"type":65,"coordinates":96},[97,98],112.97087,28.19874,{"lat":98,"lon":97},[101],{"name":102,"role":73,"phone":103,"phoneExt":11,"email":104},"Hongjun Zhao","860731-84327100","hongjunzhao2015@sina.com",{"facility":106,"status":59,"city":107,"state":108,"zip":11,"country":62,"countryCode":63,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"The Affiliated Hospital of Xuzhou Medical University","Xuzhou","Jiangsu",{"type":65,"coordinates":110},[111,112],117.28386,34.20442,{"lat":112,"lon":111},[115],{"name":116,"role":73,"phone":117,"phoneExt":11,"email":118},"Dongmei Zhou","860516-85805991","13813283017@163.com",{"facility":120,"status":78,"city":121,"state":122,"zip":11,"country":62,"countryCode":63,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":65,"coordinates":124},[125,126],115.85306,28.68396,{"lat":126,"lon":125},[129,133],{"name":130,"role":73,"phone":131,"phoneExt":11,"email":132},"Rui Wu","860791-88693035","tcmclinic@163.com",{"name":134,"role":73,"phone":135,"phoneExt":11,"email":136},"Fei Li","860791-88692517","ncyf.lifei@outlook.com",{"type":138,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":149,"type":150},38,"ESTIMATED","INTERVENTIONAL",[153],"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.",[156,157],"Systemic Lupus Erythematosus (SLE)","Idiopathic Inflammatory Myopathies(IIM)","2026-01-29",{"date":160,"type":161},"2026-02-02","ACTUAL",{"date":158,"type":161},{"date":164,"type":150},"2030-01-31",{"name":5,"class":6},5]