[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618426":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":20,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Chongqing Precision Biotech Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T treatment group","EXPERIMENTAL","This trial was designed as an open, single-arm, single-center, dose-increasing trial.",[13],"Biological: CD19 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD19 CAR-T cells","Three dose groups (1.5×10\\^5\u002Fkg, 5×10\\^5\u002Fkg, 10×10\\^5\u002Fkg) were set up, starting from the low dose group climbing to explore the safe and effective dose.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lingyun Sun","CONTACT","13705186409","lingyunsun2012@163.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Affiliated Drum Tower Hospital, Medical School of Nanjing University","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":36,"coordinates":37},"Point",[38,39],118.77778,32.06167,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100618426","phase-1-study-of-ultra-fast-cd19-car-t-therapy-for-refractory-sle-100618426",false,"NCT07331467","Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE","Study of Ultra-Fast Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* Diagnosed with SLE according to the 2019 EULAR\u002FACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg\u002Fkg\u002Fd or other equivalent amount of other steriod), and\u002For hydroxychloroquine, and at least 2 DMARDs(include cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, beliumab, and rituximab) or intolerant to standard treatments;\n* SLEDAI-2K score ≥ 8 points;\n* Meet the standards of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;\n* Negative pregnancy test for female subjects of childbearing age, and agree to take effective contraceptive measures until one year after CAR-T infusion;\n* Participant or his\u002Fher guardians agree to participate in the clinical trial and sign the informed consent form which indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n* Central nervous system (CNS) disease: CNS neurolupus requires intervention within 30 days;\n* Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); or NYHA classification class IV; or combined with moderate to massive pericardial effusion, serious myocarditis, etc; or patient with unstable vital signs who need hypertensive drugs;\n* The functions of important organs meet one of the following conditions: (1)renal function: eGFR\\\u003C30mL\u002Fmin\u002F1.73m2 or require renal replacement therapy; (2)liver function: AST and ALT\\>3.0 ULN, total Bilirubin (TBIL) in serum \\>2.0×ULN; (3)lung function: SpO2\\\u003C92% with no oxygen inhalation;\n* Uncontrollable infection or active infection that requires systemic treatment within 3 months prior to screening;\n* Received hematopoietic stem cell transplantation within 3 months prior to screening, or ≥Grade 2 GVHD within 2 weeks prior to screening;\n* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; or positive for human immunodeficiency virus (HIV) antibodies; or syphilis test positive;\n* Suffered from active pulmonary tuberculosis at screening;\n* Received live vaccine within 4 weeks prior to screening;\n* Positive in blood pregnancy test;\n* Suffered from malignant disease such as tumors (excluding tumors without active lesions and ending treatment for more than 5 years, as well as fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, thyroid cancer after radical resection, ductal carcinoma in situ after radical resection);\n* Patients who participated in other clinical study within 3 months prior to screening;\n* Any other conditions that the investigators deem it unsuitable for the study.","ALL","18 Years",{"count":55,"type":56},18,"ESTIMATED","INTERVENTIONAL",[59],"PHASE1","This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.",[62],"Systemic Lupus Erythematosus",[64,65],"CD19","CAR-T","2025-12-28",{"date":68,"type":69},"2026-01-12","ACTUAL",{"date":71,"type":56},"2026-01",{"date":73,"type":56},"2028-08",{"name":5,"class":6},1]