[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570705":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":38,"collaborators":40,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"National University of Malaysia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"autologous CD19 CAR T-cells","EXPERIMENTAL","Single Infusion of autologous CD19 CAR T- cells",[13],"Biological: CD19 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD19 CAR-T cells","Study participant will be given single infusion of autologous CD19 CAR-T cells following lymphodepletion chemotherapy",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"S Fadilah Abdul Wahid, PhD","CONTACT","+60391456450","sfadilah@hctm.ukm.edu.my",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":20,"geoPoint":20,"contacts":36},"University Kebangsaan Malaysia Medical Center","RECRUITING","Bandar Tun Razak","Kuala Lumpur","56000","Malaysia","MY",[37],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":39,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[41],{"name":42,"class":43},"Plutonet Sdn Bhd","UNKNOWN","100570705","phase-1-autologous-cd19-car-t-cell-therapy-for-severe-refractory-systemic-lupus-erythematosus-sle-100570705",false,"NCT06710717","Autologous CD19 Car T-Cell Therapy For Severe Refractory Systemic Lupus Erythematosus (SLE)","Autologous CD19 Car T-Cell Therapy For Patients With Severe Refractory Systemic Lupus Erythematosus - A Pilot Study","Inclusion Criteria:\n\n\\-\n\nAged between ≥ 18 to ≤ 65 years Clinical Diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria (Fanouriakis et al., 2019) Positive anti-nuclear antibody (ANA) (titer ≥1:80 ), anti-dsDNA (≥30 IU\u002FmL on enzyme-linked immunosorbent assay \\[ELISA\\]), or anti-Smith at screening or by documented medical history Active disease (defined by not being in remission according to DORIS criteria or in a low disease activity state \\[LLDAS\\]) (Franklyn et al., 2016, van Vollenhoven et al., 2021) With at least one active organ system involvement Persistent active disease with insufficient response to glucocorticoids and at least 2 of the following treatments for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.\n\nSerum ALT \\\u003C5 times the normal value, serum bilirubin \\\u003C3 times the normal value, Left ventricular ejection fraction \\>45% Life expectancy of more than 3 months Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Psychological, sociological or geographical conditions precluding compliance A female of childbearing age must have a negative pregnancy test and is on two effective contraception methods A male must use two effective contraception methods\n\nExclusion Criteria:\n\n\\-\n\nActive cancer or receiving cancer treatment Evidence of severe lung, FVC \\\u003C45% and\u002For DLCO (corrected for Hb) \\\u003C30% predicted, heart (NYHA class III\u002FIV, arrhythmia, AV block, uncontrolled hypertension), liver failure or severe neurologic disorders.\n\nPre-existing irreversible kidney damage and creatinine clearance below 30 ml\u002Fmin ( to review) Severe pancytopenia HIV positivity. Active Hepatitis B, C infection. Septicemia. Pregnant\u002Fnursing female. Receiving stem cell transplant within 12 weeks of enrolment, chemotherapy or radiotherapy within 8 weeks of enrolment Active CNS involvement.","ALL","18 Years","65 Years",{"count":55,"type":56},5,"ESTIMATED","INTERVENTIONAL",[59],"PHASE1","This pilot clinical study aims to evaluate the effectiveness of Chimeric Antigen Receptor (CAR) T-cell therapy in treating severe, refractory systemic lupus erythematosus (SLE), an autoimmune disease driven by autoreactive B-cells. Current treatments for severe SLE, including glucocorticoids, cytotoxic, and immunosuppressive drugs, have significant limitations. These treatments do not adequately control the underlying autoimmune process and require long-term use, leading to chronic side effects and often failing to prevent permanent organ damage. Given the high prevalence and mortality rates associated with SLE in regions like Asia and Malaysia, there is a pressing need for more effective therapies.",[62],"Systemic Lupus Erythematous (SLE)",[64,65,66,67],"CAR T cells","SLE","treatment-refractory","severe SLE","2025-05-22",{"date":70,"type":71},"2025-05-29","ACTUAL",{"date":73,"type":71},"2025-01-03",{"date":75,"type":56},"2029-01-02",{"name":5,"class":6},1]