[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614012":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":37,"responsibleParty":75,"collaborators":77,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":11,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Chengdu Ucello Biotechnology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"UCAR-T cells treatment","EXPERIMENTAL",null,[13],"Drug: allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA","intravenous injection of allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Tao Wang, M.D.","The General Hospital of Western Theater Command","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Mei Dong Jiang, M.D.","Yancheng Third People's Hospital",[29,33],{"name":22,"role":30,"phone":31,"phoneExt":11,"email":32},"CONTACT","+8613550080505","cdjqzyywt@126.com",{"name":34,"role":30,"phone":35,"phoneExt":11,"email":36},"Xia zhao He, M.D. & Ph.D.","+8613350084795","wangtaohhzx@hotmail.com",[38,60],{"facility":27,"status":39,"city":40,"state":41,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Yancheng","Jiangsu","China","CN",{"type":45,"coordinates":46},"Point",[47,48],120.1573,33.3575,{"lat":48,"lon":47},[51,55,59],{"name":52,"role":30,"phone":53,"phoneExt":11,"email":54},"Dongmei Jiang, M.D.","+86051581606513","penghaokuaile@163.com",{"name":56,"role":30,"phone":57,"phoneExt":11,"email":58},"Jing Zhao, M.S.","+86051581608812","ycsyllsc@163.com",{"name":52,"role":24,"phone":11,"phoneExt":11,"email":11},{"facility":23,"status":61,"city":62,"state":63,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"NOT_YET_RECRUITING","Chengdu","Sichuan",{"type":45,"coordinates":65},[66,67],104.06667,30.66667,{"lat":67,"lon":66},[70,74],{"name":71,"role":30,"phone":72,"phoneExt":11,"email":73},"lin Ling, Bachelor's degree","+8602886570332","linglinlam@163.com",{"name":22,"role":24,"phone":11,"phoneExt":11,"email":11},{"type":76,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[78,80],{"name":23,"class":79},"OTHER",{"name":27,"class":81},"UNKNOWN","100614012","early-phase-1-allogeneic-ucb-derived-car-t-for-sle-100614012",false,"NCT07274059","Allogeneic UCB-derived CAR-T for SLE","Clinical Study on the Safety and Efficacy of Allogeneic, Umbilical Cord Blood Derived CAR T-cell Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), regardless of gender.\n* Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE\n* Treatment refractory: failed ≥ 2 conventional SLE treatments for at least 3 months.\n* Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥ 8.\n* Adequate function of major organs as follows:\n\nBone marrow function: a. Neutrophil count ≥ 1 × 10⁹\u002FL (no colony-stimulating factor therapy within 2 weeks prior to testing, excluding neutropenia caused by SLE); b. Hemoglobin ≥ 60 g\u002FL.\n\nLiver function: Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (excluding ALT elevation caused by SLE); Aspartate aminotransferase (AST) ≤ 3 × ULN (excluding AST elevation caused by SLE); Total bilirubin (TBIL) ≤ 1.5 × ULN (excluding TBIL elevation caused by SLE).\n\nRenal function: Creatinine clearance rate (CrCl) ≥ 30 mL\u002Fminute (calculated by Cockcroft\u002FGault formula, excluding CrCl reduction caused by SLE).\n\nCoagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN.\n\nCardiac function: Hemodynamically stable.\n\n* Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse during the study treatment period and for at least 6 months after the end of study treatment. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to study enrollment and must not be breastfeeding.\n* Voluntarily agrees to participate in the clinical study, signs the informed consent form (ICF), and demonstrates good compliance with study procedures and follow-up.\n\nExclusion Criteria:\n\n* History of severe drug allergies or atopic diathesis.\n* Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n* Cardiac function insufficient to tolerate the study treatment.\n* Congenital immunoglobulin deficiency.\n* History of malignant tumors within the past 5 years.\n* End-stage renal failure.\n* Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.\n* History of mental illness or severe cognitive impairment.\n* Use of disease-modifying immunosuppressive agents within 5 half-lives or biological agents within 4 weeks prior to enrollment.\n* Pregnant females or females planning to become pregnant.\n* Other conditions deemed by the investigator to preclude study participation.","ALL","18 Years","75 Years",{"count":93,"type":94},48,"ESTIMATED","INTERVENTIONAL",[97],"EARLY_PHASE1","The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.",[100],"SLE - Systemic Lupus Erythematosus",[102,103,104,105],"allogeneic","CAR-T","umbilical cord blood","SLE","2025-12-09",{"date":108,"type":109},"2025-12-10","ACTUAL",{"date":111,"type":109},"2025-03-26",{"date":113,"type":94},"2037-12-31",{"name":5,"class":6},2]