[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"system-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:system-lupus-erythematosus":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100615909","the-value-of-interleukin-1-and-interleukin-33-genetic-expression-in-the-pathogenesis-and-differentiation-of-primary-itp-and-sle-related-thrombocytopenia-100615909",false,"NCT07298733","The Value of Interleukin-1β and Interleukin-33 Genetic Expression in the Pathogenesis and Differentiation of Primary ITP and SLE-Related Thrombocytopenia","Inclusion Criteria:\n\n* • Adults (18-60 years).\n\n  * Diagnosed primary ITP\n  * Diagnosed SLE with thrombocytopenia\n\nExclusion Criteria:\n\n* • Patients on recent immunosuppressive therapy (\\\u003C4 weeks).\n\n  * Co-existing infections, malignancies, or other autoimmune cytopenias","ALL","18 Years","60 Years",{"count":19,"type":20},300,"ESTIMATED","OBSERVATIONAL","Primary immune thrombocytopenia (ITP) is an autoimmune- mediated acquired bleeding disorder, defined as a platelet count less than 100×109\u002FL without other causes of isolated thrombocytopenia. The etiology of ITP is complex and heterogeneous, and as no specific biomarkers are indicating its presence, ITP remains a diagnosis of exclusion. The heterogeneous nature of ITP is evident in the differences in clinical presentation and response to regular treatment among patients and the multiple mechanisms that have been forwarded to account for it, such as autoantibodies, T cell dysregulation, and impaired megakaryocytes. Except primary ITP, all forms of immune-mediated thrombocytopenia is defined as secondary ITP. Secondary ITP has several causes, including autoimmune diseases such as systemic lupus erythematosus",[24,25],"Immune Thrombocytopenia","System; Lupus Erythematosus",[27,28,29,30],"gene expression","ITP","inflammation","autoimmune","NOT_YET_RECRUITING","2025-12-09",{"date":34,"type":35},"2025-12-23","ACTUAL",{"date":37,"type":20},"2026-01-01",{"date":39,"type":20},"2026-12-31",{"name":41,"class":42},"Sohag University","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100616096","early-phase-1-clinical-study-of-bct301-cell-injection-therapy-for-refractory-autoimmune-diseases-100616096","NCT07301164","Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases","A Study of BCT301 (Anti-CD19 Chemically Induced Pluripotent Stem Cell (CiPSC)-Derived CAR-iT Cells) Therapy for Refractory Autoimmune Diseases","Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n1. Voluntarily sign the informed consent form.\n2. Male or female, aged 18-80 years (inclusive), with a body weight ≥40 kg.\n3. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the treatment period and for at least 6 months after the end of the treatment. Female participants of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to enrollment and must not be breastfeeding.\n4. Participants currently receiving one or more of the following treatments at stable doses: glucocorticoids, antimalarials, immunosuppressants:\n\n   1. If the participant is receiving glucocorticoid therapy, the following conditions must be met: the maximum dose at screening and during the screening period is 30 mg\u002Fday of prednisone (or equivalent). The dose must have been stable for ≥7 days prior to screening, and adjustments during the screening period must not exceed 5 mg\u002Fday of prednisone (or equivalent);\n   2. If the participant is receiving antimalarials and\u002For conventional immunosuppressants: the treatment must have been initiated ≥12 weeks prior to screening. The dose must have been stable for ≥8 weeks prior to screening and remain stable during the screening period;\n   3. If biological agents (belimumab, telitacicept, rituximab, etc.) were used prior to the screening period, a washout period of at least 5 half-lives must be completed before screening.\n5. Peripheral blood B cells must show positive CD19 expression as detected by flow cytometry.\n\nDisease-Specific Inclusion Criteria\n\n1\\. Systemic Lupus Erythematosus (SLE)\n\n1. Meet the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE.\n2. Have moderate to severe disease activity at screening, with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score \\>6.\n3. Have inadequate response to conventional therapy or experience disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n4. Have positive serological autoantibody tests: positive antinuclear antibodies (ANAs) and\u002For anti-ds-DNA antibodies and\u002For anti-Sm antibodies.\n\n2\\. Systemic Sclerosis (SSc)\n\n1. Meet the 2013 EULAR\u002FACR classification criteria for SSc.\n2. Fulfill either (a) or (b) below:\n\n   1. Inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n   2. Disease progression: skin progression with a modified Rodnan Skin Score (mRSS) ≥10; and\u002For interstitial lung disease evidenced by ground-glass opacities on high-resolution computed tomography (HRCT); a decline in forced vital capacity (FVC) ≥10%, or a decline in FVC ≥5% accompanied by a decline in diffusing capacity for carbon monoxide (DLCO) ≥15%.\n3. Have positive SSc-related autoantibodies. 3. Antiphospholipid Syndrome (APS)\n\n1\\) Meet the 2006 Sydney criteria for primary antiphospholipid syndrome. 2) Have medium to high titers of antiphospholipid antibodies (lupus anticoagulant \\[LA\\], anti-β2-glycoprotein 1 \\[β2GP1\\] IgG\u002FIgM, or anti-cardiolipin \\[aCL\\] IgG\u002FIgM); 3) Fulfill either (a) or (b) below:\n\n1. Receiving standard treatment with warfarin or alternative vitamin K antagonists (maintaining target international normalized ratio \\[INR\\]), or standard therapeutic doses of low molecular weight heparin (LMWH), and\u002For glucocorticoids and immunosuppressants\u002Fbiologics (e.g., cyclophosphamide, cyclosporine, tacrolimus, rituximab, etc.).\n2. Meet all four criteria for catastrophic APS:\n\ni) Involvement of three or more organs, systems, and\u002For tissues; ii) Development of manifestations within one week; iii) Histopathological confirmation of small vessel occlusion in at least one organ or tissue; iv) Positive antiphospholipid antibodies (aPL).\n\n4\\. Inflammatory Myopathy (IM)\n\n1. Meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including dermatomyositis, polymyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy).\n2. Have positive myositis-specific autoantibodies.\n3. For participants with muscle involvement: a Manual Muscle Test-8 (MMT-8) score \\\u003C142, and at least two of the following five core abnormalities: Physician Global Assessment ≥2, Patient Global Assessment ≥2, or extramuscular disease activity score ≥2; Health Assessment Questionnaire (HAQ) total score ≥0.25; muscle enzyme levels ≥1.5 times the upper limit of normal; or MMT-8 ≥142 but with active interstitial lung disease (ground-glass opacities on HRCT).\n\n5\\. Sjögren's Syndrome (SS)\n\n1. Meet the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome.\n2. Have a EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5.\n3. Have positive anti-SSA\u002FRo antibodies.\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\n6\\. Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)\n\n1. Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis (AAV), including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Have a history of or currently positive ANCA.\n3. Have a Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63).\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\nExclusion Criteria:\n\nStudy participants who meet any of the following criteria will be excluded from the study:\n\n1. Any medical condition that, in the opinion of the investigator, would contraindicate participation in the study, such as a life-threatening illness.\n2. Decreased organ function reserve not attributable to the primary disease:\n\n   a) Neutrophil count \\\u003C1×10⁹\u002FL; lymphocyte count \\\u003C0.3×10⁹\u002FL; hemoglobin \\\u003C70 g\u002FL; platelet count \\\u003C50×10⁹\u002FL; b) Alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN); aspartate aminotransferase (AST) \\>3 × ULN; total bilirubin \\>2 × ULN; c) Creatinine clearance \\\u003C40 mL\u002Fmin; estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²; or serum creatinine \\>2.5 mg\u002FdL; d) Left ventricular ejection fraction (LVEF) \\\u003C45% as measured by echocardiography; e) Oxygen saturation \\\u003C92% on room air.\n3. History of alcohol or substance abuse within the past 24 weeks.\n4. History of malignancy other than B-cell lymphoma.\n5. Presence of infections including human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency, syphilis, chronic hepatitis B or C, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n6. Known active tuberculosis (TB) infection or active bacterial infection.\n7. History of myocardial infarction, coronary angioplasty or stenting, unstable angina, clinically significant arrhythmia, or other clinically significant cardiac disease within 6 months prior to screening.\n8. Symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening, except in cases of antiphospholipid syndrome (APS).\n9. History of severe allergic reaction to any component of cellular therapy or other immunotherapeutic agents.\n10. Prior organ transplant requiring ongoing immunosuppressive therapy.\n11. Concurrent participation in another clinical trial that may interfere with disease assessment or study treatment.\n12. Prior treatment with CD19- and\u002For BCMA-targeted therapy or any CAR-T cell product; except in cases where prior therapy is deemed to have clearly failed (e.g., no response, short duration of response, or disease progression) as assessed by the investigator, the current disease state warrants the study treatment, and there is no clear evidence that toxicity from prior therapy would compromise the safety of the current study.\n13. Severe psychiatric disorder or significant cognitive impairment.\n14. Pregnancy, lactation, or planned pregnancy.\n15. Any other condition that, in the judgment of the investigator, would make the participant unsuitable for enrollment in this clinical trial.","80 Years",{"count":52,"type":20},10,"INTERVENTIONAL",[55],"EARLY_PHASE1","This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.",[58,59,60,61,62,63],"System Lupus Erythematosus","Systemic Sclerosis (SSc)","Inflammatory Myositis","Antiphospholipid Syndrome","ANCA Associated Vasculitis","Sjogren Syndrome",{"date":65,"type":35},"2025-12-24",{"date":67,"type":20},"2025-12-11",{"date":69,"type":20},"2028-12-31",{"name":71,"class":42},"Peking University Third Hospital",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":53,"phases":82,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100580726","phase-1-a-study-of-sctb35-in-patients-with-systemic-lupus-erythematosus-100580726","NCT06841042","A Study of SCTB35 in Patients with Systemic Lupus Erythematosus","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTB35 in Patients with Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Age 18-75 years；\n2. Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR\u002FEULAR criteria);\n3. SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevated anti-dsDNA antibody levels;\n4. Positive for ANA (1:80) or positive for anti-dsDNA and\u002For anti-Sm antibodies within the last 12 months or at screening;\n5. Currently receiving ≥1 stable dose of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs\n\n   1. Stable corticosteroid dose for ≥4 weeks prior to baseline;\n   2. Stable dose of antimalarial drugs for ≥4 weeks prior to baseline;\n   3. Stable dose of immunosuppressive agents for ≥4 weeks prior to baseline;\n6. All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 6 months after the last dose of the study drug;\n7. Understanding of the study procedures and voluntary signing of the informed consent form.\n\nExclusion Criteria:\n\n1. Severe active or unstable lupus-related neuropsychiatric disorders;\n2. Other autoimmune diseases that may interfere with efficacy evaluation;\n3. Catastrophic antiphospholipid syndrome;\n4. Received treatments that may affect the drug's effect:\n5. Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening;\n6. Clinically significant bleeding risk;\n7. Abnormal laboratory results:\n\n   1. AST or ALT \\>2.5 x ULN;\n   2. Total bilirubin \\>1.5 x ULN;\n   3. ANC \\\u003C1.5x10⁹\u002FL;\n   4. Platelets \\\u003C75x10⁹\u002FL;\n   5. Hemoglobin \\\u003C100g\u002FL;\n8. eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²;\n9. Positive serum HCG;\n10. Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);\n11. Participants with recurrent, chronic, or other active infections as assessed by the investigator;\n12. Severe or uncontrolled disease, which would prevent participation in the study;\n13. Positive viral serology tests, including HIV, HCV, and HBV;\n14. Tuberculosis screening: Known active tuberculosis or latent tuberculosis infection (LTBI);\n15. Any type of active infection except nail bed fungal infections;\n16. Severe infections;\n17. History of progressive multifocal leukoencephalopathy (PML);\n18. Diagnosed with type 1 or type 2 diabetes with poor control;\n19. Uncontrolled hypertension (systolic \\>140 mmHg or diastolic \\>90 mmHg);\n20. History of malignancy within 5 years prior to baseline;\n21. Alcohol abuse or drug misuse within 12 months prior to screening;\n22. Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTB35 injection;\n23. Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;\n24. Participants with mental disorders or poor compliance;\n25. Severe lupus nephritis;\n26. History of solid organ or hematopoietic stem cell\u002Fbone marrow transplant, or expected to undergo transplant surgery during the study;\n27. Pregnant or breastfeeding;\n28. Any other condition that the investigator deems unsuitable for participation in the study.","75 Years",{"count":81,"type":20},168,[83,84],"PHASE1","PHASE2","This study is a multicenter Phase Ib\u002FII clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).",[58],"RECRUITING","2025-02-18",{"date":90,"type":35},"2025-02-21",{"date":92,"type":20},"2025-02",{"date":94,"type":20},"2028-10",{"name":96,"class":97},"Sinocelltech Ltd.","INDUSTRY",14]