[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626184":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":73,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Vinmec Research Institute of Stem Cell and Gene Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD19 CAR-T Cell Therapy","EXPERIMENTAL","Participants will receive autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy following leukapheresis and protocol-defined lymphodepleting chemotherapy. A single intravenous infusion of CD19 CAR-T cells will be administered, with subsequent safety monitoring and follow-up according to the study protocol.",[13],"Biological: Autologous CD19-Targeted CAR-T Cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Autologous CD19-Targeted CAR-T Cells","Autologous chimeric antigen receptor T cells targeting CD19, manufactured from participants' peripheral blood T cells collected by leukapheresis. Cells are genetically modified ex vivo to express a CD19-specific CAR, expanded, and administered as a single intravenous infusion following protocol-defined lymphodepleting chemotherapy. Participants undergo post-infusion monitoring for safety and immunological effects according to the study protocol.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Liem T Nguyen, PhD","Vinmec Research Institute of Stem Cell and Gene Technology, VinUniversity","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+84 986 565 015","liem.nt@vinuni.edu.vn",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Van T Hoang, PhD","+84 936 449 481","van.ht@vinuni.edu.vn",[36],{"facility":5,"status":20,"city":37,"state":20,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hanoi","10000","Vietnam","VN",{"type":42,"coordinates":43},"Point",[44,45],105.84117,21.0245,{"lat":45,"lon":44},[48],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100626184","phase-1-cd19-car-t-cell-therapy-for-refractory-systemic-lupus-erythematosus-100626184",false,"NCT07432334","CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus","Evaluation of the Safety and Efficacy of CD19 CAR T-Cell Therapy for the Treatment of Refractory Systemic Lupus Erythematosus: A Phase I Clinical Trial","Inclusion Criteria:\n\n* Age 16 to 55 years, male or female\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria with a total score ≥ 10\n* SLEDAI-2K score ≥ 8 at screening (with at least 4 points derived from laboratory parameters; excluding points attributable to central nervous system involvement)\n* Positive antinuclear antibody (ANA ≥ 1:80) OR positive anti-dsDNA OR positive anti-Sm antibody at screening or documented in medical history\n\nRefractory systemic lupus erythematosus or refractory lupus nephritis defined as one of the following:\n\nRefractory SLE:\n\n\\- Failure to achieve adequate response, partial response, or stable disease control after ≥ 6 months of standard-of-care therapy (documented compliance). Standard therapy includes corticosteroids plus hydroxychloroquine and at least two of the following: calcineurin inhibitors, cyclophosphamide, mycophenolate mofetil, azathioprine, or B-cell-targeted therapy (e.g., rituximab, belimumab).\n\nRefractory Lupus Nephritis:\n\n* Persistent active lupus nephritis after two induction regimens, including intravenous cyclophosphamide and mycophenolate mofetil administered for ≥ 6 months (with or without calcineurin inhibitors, rituximab, or belimumab), AND:\n* Histopathologic confirmation of Class III or Class IV lupus nephritis, with or without Class V (ISN\u002FRPS 2003 classification); isolated Class V is excluded\n* Proteinuria \\> 1 g\u002F24 hours OR urine protein-to-creatinine ratio \\> 1 mg\u002Fmg\n* Adequate organ function:\n\n  * ALT ≤ 5 × upper limit of normal; total bilirubin ≤ 34 μmol\u002FL (≤ 2.0 mg\u002FdL)\n  * Pulmonary function: FVC ≥ 60% predicted OR FEV1 ≥ 60% predicted\n  * Cardiac function: LVEF ≥ 50%, no uncontrolled arrhythmia, no intracardiac thrombus, no heart failure\n* Adequate hematologic parameters:\n\n  * Absolute neutrophil count ≥ 0.8 × 10⁹\u002FL (without growth factor support)\n  * Absolute lymphocyte count ≥ 0.3 × 10⁹\u002FL\n  * Platelet count ≥ 50 × 10⁹\u002FL\n  * Hemoglobin ≥ 80 g\u002FL (≥ 8.0 g\u002FdL)\n* Ability to provide written informed consent\n* Agreement to use effective contraception during the study period (for participants of reproductive potential)\n\nExclusion Criteria:\n\n* History of significant neurologic disorders (e.g., traumatic brain injury, seizure disorder, hemorrhagic conditions, impaired consciousness)\n* Significant cardiovascular disease within 3 months prior to screening (e.g., uncontrolled hypertension, NYHA Class III-IV heart failure, severe arrhythmia, unstable angina, myocardial infarction)\n* Prior kidney transplantation\n* Severe asthma requiring long-term treatment or respiratory failure\n* Severe hemolytic anemia requiring transfusion at intervals ≤ 7 days\n* Active viral infections (e.g., hepatitis B or C, HIV, tuberculosis, malaria, syphilis, CMV, EBV) or other life-threatening infectious diseases\n* Active bacterial infection confirmed by clinical evaluation, imaging, or laboratory testing\n* Use of the following prior to leukapheresis:\n\n  * Anti-CD20 therapy, cyclophosphamide, live or attenuated vaccines within 1 month\n  * Systemic corticosteroids \\> 10 mg\u002Fday (prednisone equivalent), T-cell-targeted therapy (e.g., mycophenolate mofetil, calcineurin inhibitors), immunosuppressive agents, or antimalarial agents within 7 days\n  * Prior anti-CD19 therapy\n  * Prior T-cell-based cellular therapy or gene therapy, including CAR-T therapy\n* Current or prior malignancy\n* Known hypersensitivity to study-related agents\n* Pregnant or breastfeeding women\n* Active antiphospholipid syndrome (stable antiphospholipid antibody positivity without active APS is permitted)\n* Participation in another clinical trial at the time of screening\n* Any condition that, in the investigator's judgment, would interfere with protocol compliance or study participation","ALL","16 Years","55 Years",{"count":62,"type":63},8,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","The goal of this Phase I clinical trial is to evaluate the safety and tolerability of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in adults with refractory systemic lupus erythematosus who have demonstrated inadequate response to standard-of-care immunosuppressive treatments.\n\nThe primary questions this study aims to address are:\n\nWhat is the incidence, nature, and severity of treatment-emergent adverse events following CD19 CAR-T cell infusion? Is administration of CD19 CAR-T cell therapy feasible and tolerable in patients with refractory systemic lupus erythematosus? This study is conducted as a single-arm trial without a comparison group.\n\nParticipants will:\n\nUndergo leukapheresis for collection of autologous peripheral blood mononuclear cells Receive a protocol-defined lymphodepleting chemotherapy regimen prior to CAR-T cell infusion Receive a single intravenous infusion of approximately 1.0 × 10⁶ CD19 CAR-T cells per kilogram of body weight Undergo scheduled clinical evaluations, laboratory testing, and longitudinal follow-up to assess safety, tolerability, and clinical parameters",[69],"Refractory Systemic Lupus Erythematosus",[71,72],"CD19 CAR-T","Autoimmune Disease","NOT_YET_RECRUITING","2026-02-24",{"date":76,"type":77},"2026-02-25","ACTUAL",{"date":79,"type":63},"2026-03-01",{"date":81,"type":63},"2027-11",{"name":5,"class":6},1]