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0090","Metropolitan Borough of Wirral","Merseyside","L63 4JY",{"type":54,"coordinates":1221},[1222,1223],-3.10501,53.37616,{"lat":1223,"lon":1222},[1226],{"name":1227,"role":39,"phone":11,"phoneExt":11,"email":11},"Site 0090",{"facility":1229,"status":98,"city":1230,"state":11,"zip":1231,"country":1189,"countryCode":1190,"cosmosGeoPoint":11,"geoPoint":11,"contacts":1232},"Derriford Hospital, University Hospitals Plymouth NHS Trust","Crownhill, Plymouth","PL6 8DH",[1233],{"name":1234,"role":39,"phone":1235,"phoneExt":11,"email":11},"David Burns, Site 0102","+44 1752 431043",{"facility":1237,"status":47,"city":1238,"state":11,"zip":1239,"country":1189,"countryCode":1190,"cosmosGeoPoint":1240,"geoPoint":1244,"contacts":1245},"Local Institution - 0091","Liverpool","L9 7AL",{"type":54,"coordinates":1241},[1242,1243],-2.97794,53.41058,{"lat":1243,"lon":1242},[1246],{"name":1247,"role":39,"phone":11,"phoneExt":11,"email":11},"Site 0091",{"type":1249,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100594172","phase-2-a-study-of-cc-97540-bms-986353-or-zola-cel-cd19-targeted-nex-t-car-t-cells-in-participants-with-active-sle-despite-immunosuppressants-breakfree-sle-100594172",false,"NCT07015983","A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)","A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)","Inclusion Criteria:\n\n* Participants must meet EULAR\u002FACR 2019 criteria for SLE.\n* Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.\n* Participants must have active disease when signing ICF.\n\nExclusion Criteria:\n\n* Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.\n* Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies.\n* IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.\n* Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant.\n* Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration.\n* Participant must not have inadequate organ function.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","16 Years",{"count":1260,"type":1261},89,"ESTIMATED","INTERVENTIONAL",[1264],"PHASE2","The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.",[1267,1268],"Lupus Erythematosus, Systemic","Lupus Nephritis",[1270,1271,1272,1273,1274,1275,1276,1277,1278,1279,24,25],"Lupus","SLE","LN","CAR T","Cell Therapy","CD19 CAR T","CD19","CD19 NEX-T","CD19 NEXT","CD19 NEX T","2026-06-23",{"date":1282,"type":1283},"2026-06-24","ACTUAL",{"date":1285,"type":1283},"2025-07-14",{"date":1287,"type":1261},"2032-06-15",{"name":5,"class":6},96]