[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588633":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"China Immunotech (Beijing) Biotechnology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"YTS109 cell","EXPERIMENTAL","Subjects will receive YTS109 cell (1E6 STAR+T cell\u002Fkg or 2E6 STAR+T cell\u002Fkg) once in this study.",[13],"Drug: YTS109 cell injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","YTS109 cell injection","Subjects will receive YTS109 Cell Injection(1E6 STAR+T cell\u002Fkg or 2E6 STAR+T cell\u002Fkg) once in this study.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jing Pan","CONTACT","010-63290612","panj@gobroaddhealthcare.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Beijing GoBroad Hospital","RECRUITING","Beijing","Beijing Municipality","102206","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.39723,39.9075,{"lat":40,"lon":39},[43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100588633","phase-1-a-clinical-study-of-yts109-cell-in-rr-systemic-lupus-erythematosus-100588633",false,"NCT06943937","A Clinical Study of YTS109 Cell in R\u002FR Systemic Lupus Erythematosus","An Exploratory Clinical Study of YTS109 Cell in Subjects With Refractory Disease Systemic Lupus Erythematosus","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Meet the EULAR\u002FACR 2019 SLE Classification Criteri:\n\nCohort 1: Refractory Lupus Nephritis: Defined as failure to achieve remission after treatment with corticosteroids and ≥2 immunosuppressants (e.g., CTX, tacrolimus, MMF, cyclosporine) and\u002For biologics, with urine protein\u002Fcreatinine ratio (UPCR ≥1.0 g\u002Fg) , and renal pathology requirement scriteria: ISN\u002FRPS 2003 Class III\u002FIV proliferative lupus nephritis (or combined with type V features) , with ≤50% glomerulosclerosis.\n\nCohort 2: Refractory Immune Thrombocytopenia: Requires treatment failure with: Failed treatment with at least 1 course of MP shock (1g for 3 days) or high- dose glucocorticosteroids (1mg\u002Fkg\u002Fd equivalent dose of glucocorticosteroids) in combination with 1 or more immunosuppressive agents. At least 2 consecutive routine blood tests for platelets less than 50×10\\^9\u002FL and \\>30×10\\^9\u002FL were performed prior to enrolment. other non-SLE causes of thrombocytopenia, such as infections, myelosuppression and hypersplenism, were excluded.\n\n3\\. Essential Organ Function Criteria:\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use).\n\n   Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL\n\n   ≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n5\\. Voluntary participation with signed informed consent and compliance.\n\nExclusions Criteria:\n\nSubjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Severe drug allergies or hypersensitivity.\n2. Uncontrolled\u002Funtreated infections (fungal, bacterial, viral, etc.).\n3. CNS disorders (exceptions: epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis).\n4. Heart failure intolerance.\n5. Congenital immunoglobulin deficiency.\n6. Malignancy within 5 years (exceptions: localized cancers with negligible metastasis risk).\n7. End-stage renal failure.\n8. Subjects positive for: HBsAg \u002F HBcAb with HBV DNA \\> detection limit; HCV Ab + HCV RNA; HIV Ab; Syphilis test.\n9. Deep vein thrombosis\u002Fpulmonary embolism within 6 months pre- screening.\n10. Severe mental illness\u002Fcognitive impairment.\n11. Participation in other clinical trials within 3 months pre-screening.\n12. Use of immunosuppressants (within 5 half-lives) or biologics (within 4 weeks) pre-screening.\n13. Pregnancy\u002Fbreastfeeding or planned conception.\n14. Other researcher-determined ineligibility.","ALL","18 Years","65 Years",{"count":57,"type":58},36,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (1×10⁶-2×10⁶ cells\u002Fkg). The primary endpoint is observations of types, severity, and frequency of dose-limiting toxicities (DLTs) and adverse events (AEs). Secondary endpoints include the complete renal response (CRR) rate at week 12 in LN, and proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP. This single-arm, open-label trial will enroll patients across Beijing GoBroad Hospital in China.",[64,65],"Lupus Nephritis (LN)","Immune Thrombocytopenia (ITP)","2025-05-08",{"date":68,"type":69},"2025-05-13","ACTUAL",{"date":71,"type":69},"2025-04-16",{"date":73,"type":58},"2027-04-25",{"name":5,"class":6},1]