[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600252":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":109,"collaborators":20,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":20,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":20,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":20,"overallStatus":56,"whyStopped":20,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Nanjing Legend Biotech Co.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Chimeric antigen receptor NK cells (LUCAR-DKS1), single-dose for each subject.","EXPERIMENTAL","Experimental: chimeric antigen receptor NK cells (LUCAR-DKS1). Dose level1：25 millions \u002Fkg Dose level2：50 millions \u002Fkg Dose level3：100 millions \u002Fkg Dose level4：200 millions \u002Fkg Dose level5：400 millions \u002Fkg Totally 5 dose groups, each subject will be given a single-dose LUCAR-DKS1 cells infusion at a certain level, subject will be administered at day 1.",[13],"Biological: LUCAR-DKS1 NK cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","LUCAR-DKS1 NK cells","Prior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Wenfeng Tan Principal Investigator","The First Affiliated Hospital with Nanjing Medical University","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Wenbo Hu","CONTACT","13581888439","wenbo.hu@legendbiotech.cn",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Liyuan Yu","18618406418","liyuan.yu@legendbiotech.cn",[37,54,67,82,94],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"The Third The People's Hospital of BengBu","NOT_YET_RECRUITING","Bengbu","Anhui","233000","China","CN",{"type":46,"coordinates":47},"Point",[48,49],117.36083,32.94083,{"lat":49,"lon":48},[52],{"name":53,"role":29,"phone":20,"phoneExt":20,"email":20},"Hanwei Wang",{"facility":55,"status":56,"city":57,"state":41,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"The First Affiliated Hospital of USTC (Anhui Provincial Hospital)","RECRUITING","Hefei","230036",{"type":46,"coordinates":60},[61,62],117.28083,31.86389,{"lat":62,"lon":61},[65],{"name":66,"role":29,"phone":20,"phoneExt":20,"email":20},"Zhu Chen",{"facility":68,"status":56,"city":69,"state":70,"zip":71,"country":43,"countryCode":44,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Jiangsu Province Hospital","Nanjing","Jiangsu","210029",{"type":46,"coordinates":73},[74,75],118.77778,32.06167,{"lat":75,"lon":74},[78],{"name":79,"role":29,"phone":80,"phoneExt":20,"email":81},"Wenfeng Tan","18061202878","tanwenfeng2005@126.com",{"facility":83,"status":56,"city":84,"state":70,"zip":85,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"The First Affiliated Hospital of Soochow University","Suzhou","215006",{"type":46,"coordinates":87},[88,89],120.59538,31.30408,{"lat":89,"lon":88},[92],{"name":93,"role":29,"phone":20,"phoneExt":20,"email":20},"Jian Wu",{"facility":95,"status":39,"city":96,"state":97,"zip":98,"country":43,"countryCode":44,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","325015",{"type":46,"coordinates":100},[101,102],120.66682,27.99942,{"lat":102,"lon":101},[105,107],{"name":106,"role":29,"phone":20,"phoneExt":20,"email":20},"Li Sun",{"name":108,"role":29,"phone":20,"phoneExt":20,"email":20},"Songfu Jiang",{"type":110,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100600252","early-phase-1-a-study-of-lucar-dks1-in-subjects-with-relapsedrefractory-autoimmune-diseases-100600252",false,"NCT07095075","A Study of LUCAR-DKS1 in Subjects With Relapsed\u002FRefractory Autoimmune Diseases","An Open-label Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-DKS1 in Subjects With Relapsed\u002FRefractory Autoimmune Diseases (r\u002Fr AID)","* Inclusion Criteria:\n\n  1. Subjects voluntary agreement to provide written informed consent.\n  2. Aged 18 to 70 years, either sex.\n  3. Clinical laboratory values meet screening criteria.\n  4. Positive test for CD19 and\u002F or BCMA\n\nSLE:\n\n* Meets at least 1 classification criteria≥6 months for SLE.\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\nAAV:\n\n* Meets the 2022 ACR\u002FEULAR classification criteria for AAV.\n* Positive test for anti-MPO or p-ANCA or anti-PR3 or anti-MPO antibodies at screening.\n* Fulfill relapsed\u002Frefractory AAV conditions.\n\nSSc:\n\n* Meets the 2013 ACR\u002FEULAR classification criteria for SSc.\n* At screening, mRSS is higher than 10.\n* Fulfill relapsed\u002Frefractory SSc conditions.\n\nIIM:\n\n* Meets 2017 EULAR\u002FACR classification criteria for IIM.\n* Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.\n* Fulfill relapsed\u002Frefractory IIM conditions. SjS：\n* Meets the 2016 ACR\u002FEULAR diagnostic criteria for SjS.\n* Positive test for anti-SSA and\u002For anti-SSB antibodies at screening.\n* Fulfill relapsed\u002Frefractory SjS 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.\n6. Have received autologous cell therapy of any target before.","ALL","18 Years","70 Years",{"count":122,"type":123},36,"ESTIMATED","INTERVENTIONAL",[126],"EARLY_PHASE1","This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-DKS1 in adult subjects with relapsed\u002Frefractory autoimmune diseases.",[129],"Relapsed\u002FRefractory Autoimmune Diseases","2025-12-09",{"date":132,"type":133},"2025-12-10","ACTUAL",{"date":135,"type":133},"2025-10-14",{"date":137,"type":123},"2029-12-31",{"name":5,"class":6},5]