[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-myopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-myopathy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,46,67,88,105,128,173,198,220,241,267,296,318,339,365],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100611144","phase-1-an-exploratory-clinical-study-of-yts109-cell-for-rr-autoimmune-diseases-100611144",false,"NCT07236762","An Exploratory Clinical Study of YTS109 Cell for R\u002FR Autoimmune Diseases","An Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell in Subjects With Relapsing\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Essential Organ Function Criteria:\n\n\u003C!-- -->\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤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. 3. 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\n4\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1. Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE);\n2. Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows:\n\n\u003C!-- -->\n\n1. Refractory Lupus Nephritis:\n\n   1. Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.).\n   2. Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening.\n   3. Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n2. Refractory SLE-Associated Immune Thrombocytopenia:\n\n   1. Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n\n      Relapsing and refractory Sjögren's syndrome:\n      1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n      2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n      3. Testing positive for anti-SSA\u002FRo antibodies;\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\n         Relapsing and refractory Sjogren's Syndrome:\n\n      \u003C!-- -->\n\n      1. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;\n      2. Testing positive for systemic sclerosis-related antibodies;\n      3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n      5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\n      Note: Meeting either criterion 4 or 5 is sufficient.\n\n      Relapsing and refractory Inflammatory Myopathy:\n      1. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM);\n      2. Testing positive for myositis-specific antibodies;\n      3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n      5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\n      Note: Meeting either criterion 4 or 5 is sufficient.\n\n      Relapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n      1. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n      2. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n      3. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n      4. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\n         Relapsing and refractory Antiphospholipid Syndrome:\n\n      1\\. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\n      Note: Meeting either criterion 3 or 4 is sufficient.\n\n      Exclusion Criteria:\n      * Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n        1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n        2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n        3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n        4. Subjects whose cardiac function cannot tolerate the study interventions;\n        5. Subjects with congenital immunoglobulin deficiencies;\n        6. Subjects with a history of malignant tumors within the past five years;\n        7. Subjects with end-stage renal failure;\n        8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n        9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n        10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n        11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n        12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n        13. Pregnant women or women planning to become pregnant;\n        14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.","ALL","18 Years","65 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Bengbu Third People's Hospital.",[27,28,29,30,31,32],"Systemic Lupus Erythematosus","Lupus Nephritis (LN)","Sjogren's Syndrome","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Antiphospholipid Syndrome","RECRUITING","2026-03-02",{"date":36,"type":37},"2026-03-04","ACTUAL",{"date":39,"type":37},"2025-11-24",{"date":41,"type":21},"2027-11-24",{"name":43,"class":44},"China Immunotech (Beijing) Biotechnology Co., Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":14,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100611147","phase-1-exploratory-clinical-study-on-yts109-cell-therapy-for-autoimmune-diseases-100611147","NCT07236801","Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n\\- Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Essential Organ Function Criteria:\n\n\u003C!-- -->\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤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. 3. 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\n4\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1\\. Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE); 2. Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows:\n\n1. Refractory Lupus Nephritis:\n\n   ①Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.).\n   * Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening.\n\n     * Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n2. Refractory SLE-Associated Immune Thrombocytopenia:\n\n   * Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n\nRelapsing and refractory Sjögren's syndrome:\n\n1\\. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome; 2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6; 3. Testing positive for anti-SSA\u002FRo antibodies; 4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Sjogren's Syndrome:\n\n1. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;\n2. Testing positive for systemic sclerosis-related antibodies;\n3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Inflammatory Myopathy:\n\n1\\. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM); 2. Testing positive for myositis-specific antibodies; 3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n1\\. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n2\\. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n\n3\\. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n\n4\\. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Antiphospholipid Syndrome:\n\n1\\. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n  1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n  2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n  3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n  4. Subjects whose cardiac function cannot tolerate the study interventions;\n  5. Subjects with congenital immunoglobulin deficiencies;\n  6. Subjects with a history of malignant tumors within the past five years;\n  7. Subjects with end-stage renal failure;\n  8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n  9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n  10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n  11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n  12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n  13. Pregnant women or women planning to become pregnant;\n  14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":20,"type":21},[24],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across The First Affiliated Hospital of Anhui Medical University.",[56,57,58,30,31,32],"Systemic Lupus Erythematosus (SLE)","Systemic Sclerosis","Sjogren's Syndrome (SS)","2026-02-27",{"date":34,"type":37},{"date":62,"type":37},"2025-11-13",{"date":64,"type":21},"2027-11-13",{"name":43,"class":44},2,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":45},"100602439","phase-1-a-clinical-study-of-yts109-cells-for-the-treatment-of-rr-autoimmune-diseases-100602439","NCT07123519","A Clinical Study of YTS109 Cells for the Treatment of R\u002FR Autoimmune Diseases","An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\nSubjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\n* Common inclusion criteria:\n\n  1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n  2. Essential Organ Function Criteria:\n\n     2.1 Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n\n     2.2 Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).\n\n     2.3 Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines). 2.4 Coagulation: INR\u002FPT ≤1.5×ULN. 2.5 Cardiovascular: Hemodynamic stability.\n  3. 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  4. Voluntary participation with signed informed consent and compliance.\n* Specific inclusion criteria:\n\n  1. Relapsing and refractory systemic lupus erythematosus:\n\n     1.1 Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE); 1.2 Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows: 1.2.1 Refractory Lupus Nephritis:(1)Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.). (2)Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening. (3)Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n\n     1.2.2 Refractory SLE-Associated Immune Thrombocytopenia: Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n  2. Relapsing and refractory Sjögren's syndrome:\n\n     2.1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome; 2.2 Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6; 2.3 Testing positive for anti-SSA\u002FRo antibodies; 2.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n  3. Relapsing and refractory Sjogren's Syndrome:\n\n     3.1 Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis; 3.2 Testing positive for systemic sclerosis-related antibodies; 3.3 Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 3.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 3.5 Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\n     Note: Meeting either criterion 4 or 5 is sufficient.\n  4. Relapsing and refractory Inflammatory Myopathy:\n\n     4.1 Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM); 4.2 Testing positive for myositis-specific antibodies; 4.3 For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 4.5 Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\n     Note: Meeting either criterion 4 or 5 is sufficient.\n  5. Relapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n     5.1 Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n     5.2 Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n\n     5.3 A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n\n     5.4 Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n  6. Relapsing and refractory Antiphospholipid Syndrome:\n\n6.1 Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 6.2 Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 6.3 Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 6.4 For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n4. Subjects whose cardiac function cannot tolerate the study interventions;\n5. Subjects with congenital immunoglobulin deficiencies;\n6. Subjects with a history of malignant tumors within the past five years;\n7. Subjects with end-stage renal failure;\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n13. Pregnant women or women planning to become pregnant;\n14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":20,"type":21},[24],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3E6 STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Institute of Hematology \\& Blood Diseases Hospital.",[56,28,78,30,31,79],"Sjogren's Syndrome (SS)","Antiphospholipid Syndrome (APS)",[81],"Relapsing\u002FRefractory Autoimmune Diseases",{"date":34,"type":37},{"date":84,"type":37},"2025-08-13",{"date":86,"type":21},"2027-08-13",{"name":43,"class":44},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":14,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":54,"conditions":96,"keywords":98,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":45},"100600994","phase-1-a-clinical-study-of-yts109-cell-for-rr-autoimmune-diseases-100600994","NCT07104721","A Clinical Study of YTS109 Cell for R\u002FR Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1\\. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n\n2\\. Essential Organ Function Criteria:\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤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. 3. 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\n4\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1. Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE);\n2. Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows:\n\n\u003C!-- -->\n\n1. Refractory Lupus Nephritis:\n\n   * Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.).\n   * Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening.\n   * Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n2. Refractory SLE-Associated Immune Thrombocytopenia:\n\n   * Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n\nRelapsing and refractory Sjögren's syndrome:\n\n1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n3. Testing positive for anti-SSA\u002FRo antibodies;\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Sjogren's Syndrome:\n\n1\\. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis; 2. Testing positive for systemic sclerosis-related antibodies; 3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Inflammatory Myopathy:\n\n1\\. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM); 2. Testing positive for myositis-specific antibodies; 3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n1\\. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n2\\. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n\n3\\. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n\n4\\. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Antiphospholipid Syndrome:\n\n1. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome;\n2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period);\n3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide;\n4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nExclusion Criteria:\n\n\\- Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n4. Subjects whose cardiac function cannot tolerate the study interventions;\n5. Subjects with congenital immunoglobulin deficiencies;\n6. Subjects with a history of malignant tumors within the past five years;\n7. Subjects with end-stage renal failure;\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n13. Pregnant women or women planning to become pregnant;\n14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":20,"type":21},[24],[56,28,97,30,31,79],"Systemic Sclerosis (SSc)",[81],{"date":34,"type":37},{"date":101,"type":37},"2025-08-04",{"date":103,"type":21},"2028-12-30",{"name":43,"class":44},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":45},"100624723","phase-1-a-clinical-study-of-ti-0032-iii-injection-in-patients-with-relapsed-and-refractory-autoimmune-diseases-100624723","NCT07413341","A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases","A Clinical Study on the Safety and Efficacy of in Vivo CAR-T Cell Therapy (TI-0032-III Injection) for the Treatment of Relapsed and Refractory Autoimmune Diseases","in vivo CAR-T","Inclusion Criteria:\n\n* Understand trial procedures and methods, voluntarily sign the informed consent form .\n* Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n* Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.\n* Bone marrow function: neutrophil count ≥ 1.5 × 10\\^9\u002FL, lymphocyte count ≥ 0.8 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, platelet ≥ 100 × 10\\^9\u002FL. Blood transfusion and growth factors must not be used within 14 days prior to screening to meet the above requirements.\n* Coagulation function: international normalized ratio or activated partial thromboplastin time ≤ 1.5× upper limit of normal range (ULN).\n* Cardiopulmonary function: left ventricular ejection fraction ≥ 50% on echocardiography; for lung function, dyspnea ≤Grade 1 of the NCI-CTCAE version 5.0 standards when breathing room air, and pulse oximetry ≥ 92%.\n* Liver function: alanine aminotransferase ≤ 1.5 × ULN, aspartate aminotransferase ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN (total bilirubin at least ≤ 3.0 mg\u002FdL in patients with Gilbert syndrome).\n* Renal function: creatinine clearance (by Cockcroft-Gault formula) ≥ 50 mL\u002Fmin.\n* Criteria for SLE：\n\n  1. Meet the 2019 European Alliance of Associations for Rheumatology\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE;\n  2. SLEDAI-2000 score \\> 6 in the moderate to severe active phase of the disease;\n  3. And have at least one British Isles Lupus Assessment Group (BILAG-2004) grade A (severe manifestation) or two grade B (moderate manifestation) organ scores, or both.\n  4. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (Above 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab, belimumab, and telitacicept.\n* Criteria for Sjögren's syndrome:\n\n  1. Meet the 2002 AECG criteria for primary Sjögren's syndrome or the 2016 ACR\u002FEULAR classification criteria;\n  2. Disease activity ESSDAI ≥ 6;\n  3. Anti-SSA\u002FRo antibody positive;\n  4. Definition of relapse\u002Frefractory: disease activity that is ineffective to conventional treatment for more than 6 months or recurs after response. Definition of conventional treatment is use of glucocorticoids and cyclophosphamide, and any of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and telitacicept.\n* Criteria for systemic sclerosis:\n\n  1. Meet the 2013 ACR classification criteria for systemic sclerosis and meet diffuse manifestations;\n  2. Combined interstitial pneumonia: interstitial changes with ground-glass exudate detected by chest high-resolution computed tomography (HRCT);\n\n     Needs to be met c. or d.:\n  3. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (Above 0.5 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n  4. Meet the definition of progression: 1) Definition of skin progression: mRSS increases b \\> 25%; 2) Definition of lung disease progression: FVC decreased by 10%, or FVC decreased by 5% and DLCO decreased by 15%.\n* Criteria for inflammatory myopathy:\n\n  1. The classification criteria for inflammatory myopathy comply with the 2017 EULAR\u002FACR (including DM, PM, ASS and NM);\n  2. For patients with muscle involvement, the MMT-8 score is less than 142 and abnormalities are found in at least two of the following five core measures (PhGA, PtGA, or extramuscular disease activity score ≥ 2 points; total HAQ score ≥ 0.25; muscle enzyme level is 1.5 times upper limit of normal);\n  3. Myositis antibody positive;\n\n     Needs to be met d. or e.:\n  4. Definition of relapse\u002Frefractory: Failure of conventional treatment or relapse of disease activity after response. Definition of conventional treatment: Use of glucocorticoids (greater than 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n  5. Meet the definition of progression: Interstitial pneumonia progresses rapidly over a short period of time.\n* Criteria for ANCA-associated vasculitis:\n\n  1. Meet the diagnostic criteria for ANCA-associated vasculitis in the 2022 ACR\u002FEULAR, including microscopic polyangiitis, granulomatous polyangiitis, eosinophilic granulomatosis with polyangiitis;\n  2. ANCA-related antibody positive (MPO-ANCA or PR3-ANCA positive);\n  3. Birmingham Vasculitis Activity Scale (BVAS) ≥ 15 points (out of a total of 63 points), indicating activity of vasculitis;\n  4. Must have at least one major item, at least three minor items, or at least two renal items, hematuria and proteinuria, in the BVAS assessment;\n  5. Definition of relapse\u002Frefractory: Failure of conventional treatment or relapse of disease activity after response. Definition of conventional treatment: Use of glucocorticoids (greater than 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n\nExclusion Criteria:\n\n* Prohibited medications and treatments:\n\n  * Any RNA-LNP products or other LNP drugs received within the past two years.\n  * Received intravenous gamma immunoglobulin within 24 weeks prior to screening.\n  * Received plasmapheresis therapy within 12 weeks prior to screening.\n  * Subjects who have not fully recovered from surgery within 4 weeks prior to screening.\n  * Epilepsy or use of psychotropic or sedative drugs during the screening period (except medications for sleeping).\n  * Received any live or live attenuated vaccine within 12 weeks prior to screening, or requiring vaccination at any time during clinical trial treatment.\n  * Participated in clinical trial of other drugs or medical devices within 12 weeks prior to screening (except for those whose screening failed).\n* Concomitant diseases or clinical condition:\n\n  * History of lupus nephropathy requiring hemodialysis or treatment with high-dose corticosteroids (\\> 100 mg\u002Fd prednisone or equivalent) within 90 days prior to baseline.\n  * Epilepsy or use of psychotropic or sedative drugs during the screening period (except medications for sleeping).\n  * Received any live or live attenuated vaccine within 12 weeks prior to screening, or requiring vaccination at any time during clinical trial treatment.\n  * Participated in clinical trial of other drugs or medical devices within 12 weeks prior to screening (except for screen failures).\n  * Have active central nervous system lupus, including meningitis aseptic, cerebral vasculitis, demyelinating syndrome, myelopathy, acute demented, psychosis, acute inflammatory demyelinating polyradiculoneuropathy, mononeuropathy (single\u002Fmultiple), cranial neuropathy, plexopathy, status epilepticus or cerebellar ataxia.\n  * Presence of other systemic inflammations such as, but not limited to, rheumatoid arthritis, juvenile chronic arthritis, spondyloarthritis, Crohn's disease, ulcerative colitis, or psoriatic arthritis within 12 weeks prior to screening (except for those with secondary Sjögren's syndrome, who should not be excluded).\n  * Subjects who have Grade III or above congestive heart failure (NYHA grade), unstable angina or myocardial infarction, poorly controlled hypertension (hypertension is diagnosed as Grade 2 or above, risk factor stratified as high-risk, systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg when taking one or two antihypertensive drugs, cerebrovascular accidents, or arrhythmias requiring treatment within 6 months prior to screening.\n  * Presence of active or uncontrolled infection requiring treatment; or have known or suspected ongoing, chronic, or recurrent infectious diseases (including but not limited to opportunistic infections such as pulmonary tuberculosis, atypical mycobacterosis, listeriosis or aspergillosis, HIV, hepatitis B or hepatitis C, etc.).\n  * Subjects with suspected allergy to TI-0032-III or similar drugs or a history of severe allergy or hypersensitivity reactions.\n  * History of thyrotoxicosis, including but not limited to diffuse toxic goitre, multinodular toxic goiter, thyroid autonomic high-function adenoma, and subacute thyroiditis, or thyroid color ultrasound suggests thyroid nodules TI-RADS classification as category 4 or 5.\n  * Previous history of splenectomy or loss of spleen function after splenic infarction or splenic vein thrombosis leading to direct vascular injury; or major surgery within 2 months prior to screening; or have planned surgery before the end of the trial.\n  * Have other serious\u002Fsevere acute or chronic mental illness, including recent (within the past 1 year) or current suicidal ideation or behavior; or a history of alcohol, drug, or chemical abuse within 1 year prior to screening.\n  * History of major organ transplant (e.g., heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation.\n  * History of malignancy, regardless of evidence of local recurrence or metastasis and regardless of treatment; or accompanied by a history of other major diseases, such as liver disease under treatment, including but not limited to acute or chronic hepatitis, liver cirrhosis or liver failure, etc.\n  * HIV positive, or active hepatitis B virus test positive (HBsAg positive, HBV-DNA ≥ 200 copies\u002FmL is required (conversion is required if HBV-DNA is in IU\u002FmL)), or anti-HCV antibody positive and HCV-RNA positive.\n  * Women who plan to become pregnant or are pregnant or breastfeeding; or blood pregnancy test positive during screening; or unable to take effective contraceptive measures within 12 months after the last infusion of investigational drug; or planned sperm\u002Fegg donation within 12 months after the last dose of the investigational drug.\n  * Other clinically significant abnormal laboratory tests or imaging tests judged by the investigator or considered unsuitable for clinical the trial for other reasons.",{"count":114,"type":21},12,[24],"This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular RNA encoding the CD19 chimeric antigen receptor (CAR), which is a therapeutic biological product. It is clinically intended for the treatment of various relapsed and refractory B cell-related autoimmune diseases, such as systemic lupus erythematosus, sjögren's syndrome, systemic sclerosis, idiopathic inflammatory myositis, and antiphospholipid syndrome.",[56,58,97,30,118],"ANCA Associated Systemic Vasculitis","2026-02-09",{"date":121,"type":37},"2026-02-17",{"date":123,"type":37},"2026-01-22",{"date":125,"type":21},"2027-01-30",{"name":127,"class":44},"Therorna",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":136,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":140,"conditions":141,"keywords":153,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":45},"100621706","mihra---patient-rooted-insights-for-shaping-myositis-science-prisms-100621706","NCT07374107","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) - A Qualitative Study of Patient-voiced Research Priorities Across Rare Myositis Diseases","MIHRA-PRISMS","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Have a clinician diagnosis of an idiopathic inflammatory myopathy or be a care partner or parent of a person living with an idiopathic inflammatory myopathy.\n* Participants who may have signed up through the MIHRA Patient Contact Registry https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F\n\nExclusion Criteria:\n\n* Under the age of 7 years old\n* Do not have a diagnosis of an inflammatory myopathy","7 Years",{"count":138,"type":21},700,"OBSERVATIONAL","Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities. The PRISMS study is a global investigation that collects patient perspectives through (mostly online) methods of open-ended questions, community forums and survey to identify the most pressing research concerns as identified by patients. Findings will be analyzed to create a patient-voiced set of research priorities that can guide the direction of research and help inform funding decisions across myositis diseases.\n\nPotential participants can express interest via https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F",[142,143,144,30,145,146,147,148,149,150,151,152],"IBM","IIM","Myositis","Dermatomyositis","Dermatomyositis, Juvenile","Anti-synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Polymyositis","Inclusion Body Myositis","Juvenile Myositis","Juvenile Dermatomyositis",[154,155,156,157,158,159,160,161,162],"myositis","rare diseases","patient priorities","patient engagement","patient initiated","patient research partners","qualitative research","mixed methods research","research priorities","2026-01-20",{"date":165,"type":37},"2026-01-28",{"date":167,"type":37},"2025-06-25",{"date":169,"type":21},"2030-12",{"name":171,"class":172},"Myositis International Health & Research Collaborative Alliance Foundation","OTHER",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100620256","phase-2-telitacicept-in-inflammatory-myopathiestelitacicept-im-100620256","NCT07355257","TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)","Safety and Efficacy of Telitacicept in Inflammatory Myopathies","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 70 years.\n* Patient has a confirmed diagnosis of inflammatory myopathy, meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for idiopathic inflammatory myopathies.\n* Inadequate response or intolerance to glucocorticoids and\u002For at least one immunosuppressant.\n* The patient or their legal guardian provides written informed consent.\n\nExclusion Criteria:\n\n* Female patients who are pregnant, breastfeeding, or planning a pregnancy during the trial period.\n* Patients with active infections, such as herpes zoster, HIV, active tuberculosis, active hepatitis, HBsAg-positive patients, or HCV antibody-positive patients.\n* Patients with positive test results indicating COVID-19 infection within 1 month prior to baseline.\n* Patients with a history of or currently diagnosed malignancy.\n* Patients with significant cardiovascular diseases (including severe arrhythmia), hepatic, renal, respiratory, endocrine, or hematological disorders, or any other medical condition that, in the investigator's judgment, would interfere with participation in the study or require hospitalization during the trial.\n* Patients who have received intravenous immunoglobulin (IVIG) or plasmapheresis within 1 month prior to baseline.\n* Patients who have received other targeted biologic therapies, such as rituximab, eculizumab, tocilizumab, etc., within 3 months prior to baseline.\n* Patients who have received any live vaccine within 3 months prior to baseline or plan to receive any vaccine during the study period.\n* Patients with a known allergy to human-derived biologics.\n* Patients currently participating in another clinical trial.\n* Patients deemed unsuitable for participation by the investigator for other reasons (e.g., severe psychiatric disorders).","75 Years",{"count":182,"type":21},30,[184,185],"PHASE2","PHASE3","The goal of this clinical trial is to evaluate the efficacy of Telitacicept in the treatment of inflammatory myopathy in patients with inflammatory diseases. The main question it aims to answer is: the safety and effectiveness of Telitacicept in treating inflammatory myopathy.",[30],"NOT_YET_RECRUITING","2026-01-19",{"date":191,"type":37},"2026-01-21",{"date":193,"type":21},"2026-02-02",{"date":195,"type":21},"2027-03-30",{"name":197,"class":172},"Zhongming Qiu",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":202,"conditions":207,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":45},"100588417","phase-1-car-t-cell-therapy-targeting-cd19-and-bcma-in-patients-with-relapserefractory-autoimmune-diseases-100588417","NCT06941129","CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse\u002FRefractory Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\nCommon Inclusion Criteria:\n\n1. Age ≥ 18 years old (inclusive), regardless of gender.\n2. Positive expression of CD19 or BCMA on peripheral blood B cells confirmed by flow cytometry.\n3. Functional requirements for major organs are as follows（Except for abnormalities related to autoimmune disease activity）: 1) Bone marrow function must meet: A. Neutrophil count ≥ 1×109\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g\u002FL; 2) Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤2×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome); 3) Renal function: creatinine clearance rate (CrCl) ≥ 30ml\u002Fminute (calculated by Cockcroft\u002FGault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded).\n4. ECOG score 0-2.\n5. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n6. Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nDisease-Specific Inclusion Criteria\n\nRefractory\u002FRelapsed Systemic Lupus Erythematosus:\n\n1. SLE meeting the 2019 the American College of Rheumatology (ACR) \u002FEuropean League Against Rheumatism (EULAR) and classification criteria.\n2. Disease activity score SLEDAI-2000 ≥ 8; or with significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of class III or IV, with or without class V, with an NIH activity index \\> 2, evidence of increased chronicity index; urine protein-to-creatinine ratio \\> 1.0 g\u002Fg, or 24-hour urinary protein \\> 1.0 g).\n3. Definition of refractory or relapsing disease: lack of response after more than 6 months of conventional therapy, or recurrence of disease activity after remission. Conventional therapy is defined as treatment with glucocorticoids in combination with one or more of the following immunomodulatory agents: cyclophosphamide, antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biologics such as rituximab, belimumab, and telitacicept.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Scleroderma fulfilling the 2013 ACR classification criteria.\n2. Positive scleroderma-related antibodies.\n3. Presence of diffuse cutaneous sclerosis or active interstitial lung disease (high-resolution computed tomography (HRCT) showing ground-glass opacities).\n4. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n5. Definition of progressive: Rapid skin progression (mRSS increase \\> 25%); or progression of lung disease (forced vital capacity (FVC) decrease by 10%, or FVC decrease by more than 5% with diffusing capacity of the lung for carbon monoxide (DLCO) decrease by 15%).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRefractory\u002FRelapsed\u002FProgressive Inflammatory Myopathy:\n\n1. Inflammatory myopathy fulfilling the 2017 EULAR\u002FACR classification criteria (including Dermatomyositis (DM), Polymyositis (PM), Anti-Synthetase Syndrome (ASS), and Necrotizing Myopathy (NM)).\n2. Muscle involvement with Manual Muscle Testing-8 (MMT-8) score less than 142 and at least two abnormalities found among the following five core measurements (Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), or extramuscular disease activity score ≥ 2; Health Assessment Questionnaire (HAQ) total score ≥ 0.25; muscle enzyme levels ≥ 1.5×ULN);\n3. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n4. Definition of progressive: Rapid progression of interstitial lung disease within a short period.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. ANCA-Associated Vasculitis fulfilling 2022 ACR\u002FEULAR criteria, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Positive ANCA-associated antibodies (MPO-ANCA or PR3-ANCA positive).\n3. The Birmingham Vasculitis Activity Scale (BVAS) ≥ 15 points (a total score of 63 points), indicating active vasculitis.\n4. Definition of refractory\u002Frelapsed: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission., or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n\nRefractory\u002FRelapsed Connective Tissue Disease-associated thrombocytopenia\n\n1. Diagnosis of connective tissue disease established according to the latest classification criteria, including but not limited to systemic lupus erythematosus, primary Sjögren's syndrome, antiphospholipid syndrome, and undifferentiated connective tissue disease.\n2. Confirmed diagnosis of connective tissue disease-associated thrombocytopenia, with platelet count \\\u003C30 × 10\\^9\u002FL, or \\\u003C50 × 10\\^9\u002FL accompanied by a bleeding tendency.\n3. Bone marrow morphology consistent with immune thrombocytopenia.\n4. Prior treatment with at least one course of corticosteroid pulse therapy, or high-dose corticosteroids in combination with one or more immunosuppressants (including biologics) for at least 3 months, without achieving partial remission, or inability to maintain efficacy during steroid tapering.\n\nExclusion Criteria:\n\n1. Subjects with a history of severe drug allergies or allergic tendencies.\n2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.\n3. Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis).\n4. Subjects with insufficient cardiac function.\n5. Subjects with congenital immunoglobulin deficiencies.\n6. History of malignancy within five years.\n7. Subjects with end-stage renal failure(LN is excluded).\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n9. Subjects with psychiatric disorders and severe cognitive impairments;\n10. Subjects who have participated in other clinical trials within the past 3 months prior to enrollment.\n11. Subjects who have received immunosuppressive agents or biologics with therapeutic effects for indications within 5 half-life prior to enrollment.\n12. Pregnant women or women planning to conceive.\n13. Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":114,"type":21},[24],[27,97,30,208,209,210],"ANCA-Associated Vasculitis (AAV)","Connective Tissue Disease-Associated Thrombocytopenia","SLE-ITP","2025-09-24",{"date":213,"type":37},"2025-09-29",{"date":215,"type":37},"2025-02-11",{"date":217,"type":21},"2028-03-18",{"name":219,"class":172},"Institute of Hematology & Blood Diseases Hospital, China",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":72,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":45},"100591301","phase-1-a-clinical-study-of-yts109-cell-in-rr-autoimmune-diseases-100591301","NCT06978647","A Clinical Study of YTS109 Cell in R\u002FR Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Detection of positive CD19 expression on peripheral blood B cells by flow cytometry.\n3. Essential Organ Function Criteria:\n\n\u003C!-- -->\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 ≤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\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1\\. Meeting the EULAR\u002FACR 2019 SLE Classification Criteria; 2. SELENA SLEDAI≥6, or the presence of significant organ involvement, such as lupus nephritis (LN), etc; 3. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing treatment with a regimen containing at least two immunosuppressive agents (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolate mofetil (MMF), and cyclosporine) and\u002For biological agents for a minimum duration of two months.\n\nRelapsing and refractory Sjögren's syndrome:\n\n1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n3. Testing positive for anti-SSA\u002FRo antibodies;\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Sjogren's Syndrome:\n\n1. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;\n2. Testing positive for systemic sclerosis-related antibodies;\n3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Inflammatory Myopathy:\n\n1. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM);\n2. Testing positive for myositis-specific antibodies;\n3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n1. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n3. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n4. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Antiphospholipid Syndrome:\n\n1\\. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nRelapsing and refractory Rheumatoid arthritis:\n\n1\\. Diagnosed with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria, with a history of RA ≥ 3 months; 2. Inadequate response to at least two conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and at least one biological agent targeting cytokines\u002Fsignal transduction pathways (such as TNFα inhibitors, IL-6R antagonists, anti-CD20 monoclonal antibodies, etc.). (Note: Inadequate response to methotrexate or leflunomide, with stable treatment for ≥ 3 months prior to screening); 3. Moderate to severe active RA: swollen joint count (SJC) ≥ 6, tender joint count (TJC) ≥ 6; 4. Elevation of at least one inflammatory marker: erythrocyte sedimentation rate (ESR) ≥ 28 mm\u002Fh or C-reactive protein (CRP) ≥ upper limit of normal (ULN).\n\nRelapsing and refractory IgG4-Related Disease:\n\n1. Meeting the 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) diagnostic criteria for IgG4-related disease (IgG4-RD);\n2. Having an IgG4-RD responder index (RI) ≥ 2 during the screening period, indicating active disease;\n3. Meeting the criteria for refractory or relapsing IgG4-RD:\n\n1\\) Refractory: Defined as a lack of response to steroid therapy or steroid plus immunosuppressive therapy (no clinical or radiological improvement, with a decrease in RI \\\u003C 2); 2) Relapse: Defined as new progression or recurrence of clinical symptoms or radiological manifestations in patients who have previously achieved remission, with or without an elevation in serum IgG4 levels (an increase in RI ≥ 2).\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n  1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n  2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n  3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n  4. Subjects whose cardiac function cannot tolerate the study interventions;\n  5. Subjects with congenital immunoglobulin deficiencies;\n  6. Subjects with a history of malignant tumors within the past five years;\n  7. Subjects with end-stage renal failure;\n  8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n  9. Subjects with psychiatric disorders or severe cognitive dysfunction;\n  10. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n  11. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n  12. Pregnant women or women planning to become pregnant;\n  13. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":114,"type":21},[24],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells\u002Fkg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.",[56,97,30,31,79,230,231,232],"Rheumatoid Arthritis (RA)","IgG4-Related Diseases","Sjogren's Syndrome","2025-07-10",{"date":235,"type":37},"2025-07-14",{"date":237,"type":37},"2025-05-19",{"date":239,"type":21},"2027-05-19",{"name":43,"class":44},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":203,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":255,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":45},"100591308","phase-1-ucar-t-cell-therapy-targeting-cd19-bcma-in-patients-with-relapse-refractory-autoimmune-diseases-100591308","NCT06978738","UCAR T-cell Therapy Targeting CD19\u002F BCMA in Patients With Relapse\u002F Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* 1.Age ≥ 18 years old (inclusive), regardless of gender.\n* 2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.\n* 3.Functional requirements for major organs are as follows:\n\n  1. Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 \\^ 9\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g\u002FL; C. Platelets ≥ 30 × 10 \\^ 9\u002FL.\n  2. Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);\n  3. Renal function: creatinine clearance rate (CrCl) ≥ 30ml\u002Fminute (calculated by Cockcroft\u002FGault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded);\n* 4.ECOG score 0-1.\n* 5.Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* 6.Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n* 7.Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.\n\nExclusion Criteria:\n\n* 1.Subjects with a history of severe drug allergies or allergic constitutions;\n* 2\\. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;\n* 3\\. Subjects with insufficient cardiac function;\n* 4\\. Subjects with congenital immunoglobulin deficiencies;\n* 5\\. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.\n* 6\\. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;\n* 7\\. Subjects with mental illness and severe cognitive dysfunction;\n* 8\\. Pregnant women or women planning to conceive;\n* 9.Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":20,"type":21},[24],"This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19\u002FBCMA CAR T-cells in With Relapse\u002FRefractory Autoimmune Diseases.",[27,251,252,57,253,30,254],"Autoimmune Hemolytic Anemia","Myasthenia Gravis","ANCA-Associated Vasculitis","IgG4-RD",[256,257],"Universal Allogeneic CAR T-cells","CD19\u002FBCMA CAR T-cells","2025-05-11",{"date":260,"type":37},"2025-05-18",{"date":262,"type":21},"2025-05",{"date":264,"type":21},"2028-11",{"name":266,"class":172},"Changzhou No.2 People's Hospital",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":283,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":45},"100577108","phase-2-bcma-cd19-car-t-therapy-for-refractory-autoimmune-diseases-100577108","NCT06794008","BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases","An Open, Single-Arm, Single-Center Clinical Study Assessing the Safety and Efficacy of BCMA-CD19 Targeted Chimeric Antigen Receptor T-Cell Therapy in Multiple Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age, 18-65 years old (inclusive), weight \\>=45kg, male and female;\n2. The diagnosis of each disease meets the following criteria:\n\nSystemic lupus erythematosus: 1997 ACR classification criteria or 2012 SLICC classification criteria Sjögren's syndrome: 2002 International Classification of Sjögren's Syndrome Inflammatory myopathies: 1977 Bohan Recommendation Systemic sclerosis: 1980 ACR classification criteria or 2013 ACR-EULAR classification criteria Behcet's disease: 1989 International Classification Criteria for Behcet's disease ANCA-associated vasculitis: 1990 ACR classification criteria IgG4-related disease: 2011 IgG4-RD composite diagnostic criteria Antiphospholipid syndrome: 2006 revision of the Sapporo APS classification criteria Acquired thrombotic thrombocytopenic purpura: consistent with a clinical diagnosis of TTP, including microscopic evidence of thrombocytopenia and red blood cell fragmentation (e.g., red blood cell fragmentation) 3. Multiple treatment regimens are ineffective or ineffective (including but not limited to high-dose glucocorticoids, adequate immunosuppressants and biologics) 4. Use of glucocorticoids (\\\u003C=1mg\u002Fkg\u002Fd prednisone or equivalent doses of other hormones), DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) must be on stable treatment for 4 weeks before receiving the first study drug, and no increase in hormone dose and other immunosuppressants throughout the study.\n\n5\\. Subjects voluntarily participate in this study and voluntarily sign the informed consent form; 6. Subjects who have the possibility of having children or whose partners have the possibility of having children must agree to use effective contraception throughout the study period (but cannot use oral estrogen, use estrogen vaginal ring, etc.) 7. Additional enrollment criteria for different diseases (related to the degree of disease activity):\n\n1. Patients with Behcet's disease must be active patients who meet the following conditions, and the active phase is defined as the emergence of new symptoms or the deterioration of existing symptoms, and one of the following conditions must be met:\n\n   A. Organ involvement: involvement of any major organ (e.g., ocular lesions, vascular lesions, central nervous system, gastrointestinal system); B. 100% increase in the number of oral or genital ulcers \\>=compared to the onset of oral\u002Fgenital ulcers compared to the first day; or an increase in the number of oral or genital ulcers by 3; C. Canker disease is at least 12 months; D. History of several oral ulcers per month E. Arthritis: \\>=50% increase in the number of swollen joints, or 3 more swollen joints; F. Skin lesions (non-oral\u002Fgenital ulcers): \\>= physician overall lesion score increased by \\>=50% or by two points in the total score.\n2. Patients with active inflammatory myopathy need to meet the following additional conditions:\n\n   Active myositis as defined by the Baseline Freehand Muscle Strength Test (MMT-8) of no more than 125\u002F150 and at least 2 additional CSMs that meet the criteria specified below:\n\n   a) Visual Analogue Scale\\[VAS\\] of patient global activity ≥2 cm, b) physician's global disease activity ≥2 cm, c) Health Assessment Questionnaire (HAQ) Disability Index ≥ 0.25 d) Elevation of at least one muscle enzyme \\[including creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), and aspartate aminotransferase (AST)\\] with a minimum level of 1.3 x upper limit of normal e) Global Extramuscular Disease Activity Score, with a minimum of 1.0 cm on a 10 cm VAS scale \\[This measure is a physician's comprehensive assessment based on the assessment of physique, skin, bone, gastrointestinal, lung, and cardiac activity scale activity scores using the Myositis Disease Activity Assessment Tool (MDAAT).\n\n   f) To ensure that we are able to recruit patients with active DM with severe rash who may not meet the MMT-8 criteria above, we recommend the use of additional inclusion criteria so that the International Myositis Assessment and Clinical Study (IMACS) Improved Definition (DOI) can be achieved: 1) MDAAT \\> on the 10 cm VAS scale 3 cm skin VAS score, and 2) at least 3 of the above 5 criteria.\n3. ANCA-associated vasculitis:\n\n   A. Comply with GPA\u002FMPA\u002FEGPA classification standards; B. Patients with severe vasculitis activity (meeting at least one of the following conditions);\n\n   a) Renal involvement is characterized by one of the following: i. Evidence of glomerulonephritis in any of the following situations: Renal biopsy shows focal necrotizing glomerulonephritis. Active urinary sediment characterized by glomerular hematuria and proteinuria ii. Patients with prior normal or no prior renal disease document, estimated glomerular filtration rate (eGFR) \\\u003C50 ml\u002Fmin\u002F1.73 m2, and prior chronic kidney disease (eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m2) showed a reduction in eGFR of at least 25% compared with the previous one.\n\n   b) Pulmonary hemorrhage due to active vasculitis satisfies all three of the following: i. Chest X-ray or CT scan showing diffuse pulmonary infiltrates ii. Pulmonary infiltrates that cannot be explained by other causes (e.g., volume overload or pulmonary infection) iii. At least one of the following: Evidence of alveolar hemorrhage on bronchoscopy or bloody bronchoalveolar lavage Hemoptysis was observed Unexplained anemia (\\\u003C10 g\u002FdL) or decreased hemoglobin (\\>1 g\u002FdL) and less than 10g\u002FdL Increased carbon dioxide dispersion\n4. Additional Enrollment Criteria for Systemic Sclerosis:\n\n   Subjects are at high risk of fatal outcomes based on the following prognostic factors: Subjects must have the following \"a\" , and at least one of \"b\" or \"c\".\n\n   a) Diffuse cutaneous scleroderma with an mRSS score of \\>=16, validated by the same physician at 2 different times \\>= 1 day apart and separated by \\\u003C 28 days.\n\n   b) Presence of SSc-related lung disease with FVC \\\u003C 70% or 70% predicted DLCO \\\u003C after hemoglobin correction and evidence of alveolitis obtained by high-resolution chest CT scan or PAL.\n\n   c) History of SSc-related nephropathy, no disease activity before enrollment screening. A history of hypertensive renal crisis with scleroderma is included in this criterion and is defined as follows: i. History of new-onset hypertension based on any of the following (must be repeated and confirmed at least 2 hours apart within 3 days of the first event) with change from baseline SBP\\>=140 mmHg DBP\\>=90 mmHg SBP rose by \\>=30 mmHg compared to baseline DBP increased by \\>=20 mmHg compared to baseline AND ii. One of the following 5 characteristics Serum creatinine increased \\>= \\>50% from baseline proteinuria: \\>=2+; Creatinine ratio \\> upper limit of normal Thrombocytopenia: \\\u003C100, 000 plts\u002Fmm3 Hemolysis: increased by blood smear or reticulocyte count\n5. Additional enrollment criteria for systemic lupus erythematosus A. The SLEDAI score of the patient before enrollment \\>= 7 points B. Failure to receive the following treatments: oral prednisone \\>=20 mg\u002Fd; Cyclophosphamide 0.4 to 0.6 g\u002Fm2 once every two weeks for 6 months, or other immunosuppressants such as mycophenolate mofetil 2 g\u002Fday for 3 months without remission.\n6. Additional enrollment criteria for antiphospholipid syndrome A. Cardiolipin antibody, lupus anticoagulant factor, and anti-β2-glycoprotein 1 antibody were all positive before enrollment.\n\n   B. History of thromboembolism or morbid pregnancy confirmed by clear objective evidence.\n7. Sjögren's disease additional enrollment criteria A. Positive anti-Ro\u002FSSA antibody screen. B. ESSDAI\\>= 6 POINTS\n8. Additional enrollment criteria for IgG4-related diseases (confirmed: A+ B+C) A. Clinical examination showing the presence of characteristic diffuse\u002Flocal swelling or masses in a single or multiple organs.\n\nB. Blood tests show elevated serum IgG4 concentration (135 mg\u002Fdl). C. Histopathological examination shows significant lymphocytic and plasmacytic infiltration and fibrosis or IgG4+ plasmacyte infiltration (IgG4+\u002FIgG+ cell ratio \\>40% and \\>10 IgG4+ plasma cells\u002FHPF).\n\nExclusion Criteria:\n\n1. Use of rituximab or other monoclonal antibodies within 1.6 months.\n2. Received high-dose glucocorticoids (\\>1 mg\u002Fkg\u002Fd) within 1 month.\n3. Serious complications: including heart failure (\\>= NYHA Class III), renal insufficiency (creatinine clearance \\\u003C=30 ml\u002Fmin), hepatic insufficiency (serum ALT or AST greater than three times the upper limit of normal, or total bilirubin greater than the upper limit of normal)\n4. Other severe, progressive, or uncontrollable hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral diseases (including demyelinating diseases such as multiple sclerosis).\n5. Known allergies, hyperreactivity, or intolerance to IL-2 or its excipients.\n6. Have a serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), or hospitalization for infection, or use of intravenous antibiotics for treatment of infection 2 months prior to the first dose of treatment.\n7. Chest imaging showing malignancy or current activity within 3 months prior to the first use of study drug Abnormalities in sexually transmitted infections (including tuberculosis).\n8. Infection with HIV (HIV antibody-positive serology) or hepatitis C (Hep C antibody-positive serology).\n\nIf seropositive, it is advisable to consult a physician with expertise in the treatment of HIV or hepatitis C virus infection.\n\n10\\. Any known malignancy or history of malignancy within the past 5 years (with the exception of non-melanoma skin cancer, non-melanoma skin cancer with no signs of recurrence or surgically cured cervical tumor within 3 months prior to the use of the first investigational agent).\n\n11\\. Have an uncontrolled mental or emotional disorder, including a history of drug and alcohol abuse within the past 3 years, which may preclude the successful completion of the study.\n\n12\\. Received or anticipated receipt of any live viral or bacterial vaccine injection within 3 months prior to the first injection of study dose, during the study, or within 4 months after the last injection of study dose. Bacillus Calmette-Guérin vaccination within 12 months of screening.\n\n13\\. Pregnant, lactating women (WCBP) who are unwilling to use medically approved contraception during treatment and for 12 months after the end of treatment.\n\n14\\. Males whose partner is of childbearing potential but who are unwilling to use appropriate medically approved contraception during treatment and for 12 months after the end of treatment.\n\n15\\. Patients with inflammatory myopathies should additionally exclude: 3) Adolescent DM or PM, myositis overlaps with another connective tissue disease, cancer-associated myositis, inclusion body myositis, or any other non-immune-mediated myopathy.\n\n4\\) Severe muscle impairment is defined as a baseline global muscle impairment score of MDI (Myositis Injury Index) \\>=5cm on 10 cm VAS.\n\n16\\. ANCA-associated vasculitis requires additional exceptions: positive anti-GBM antibodies.",{"count":275,"type":21},50,[184],"The objective of this study is to evaluate the efficacy and safety of BCMA\u002FCD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.",[27,30,97,279,231,32,280,281,282],"ANCA-associated Vasculitis","Acquired Thrombotic Thrombocytopenic Purpura","Behcet Disease","Sjogren Syndrome",[284,285,286],"CAR-T","CD19","BCMA","2025-04-01",{"date":289,"type":37},"2025-04-02",{"date":291,"type":37},"2024-12-26",{"date":293,"type":21},"2027-12-31",{"name":295,"class":172},"Peking University People's Hospital",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":143,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":45},"100585636","renal-manifestations-during-idiopathic-inflammatory-myopathies-100585636","NCT06904937","Renal Manifestations During Idiopathic Inflammatory Myopathies","Renal Manifestations During Idiopathic Inflammatory Myopathies: Real-life Study of an Alsatian Cohort (France)","Inclusion Criteria:\n\n* Major subject (≥ 18 years old)\n* Inflammatory myopathy defined by the ACR\u002FEULAR 2017 criteria\n* Kidney biopsy performed\n* Supported at the Strasbourg University Hospital during the period from January 1, 1990 to May 1, 2023.\n* Subject who has not expressed opposition to the reuse of their data for scientific research purposes.\n\nIt is the responsibility of the investigator to verify the absence of opposition in the patient's medical file.\n\nExclusion criteria:\n\n* Subject having expressed opposition to participating in the study\n* Known etiology of renal damage excluding inflammatory myopathy.",{"count":5,"type":21},"There are currently no recommendations regarding treatments for Idiopathic Inflammatory Myopathies (IIM) due to the difficulty in conducting high-powered randomized controlled trials.\n\nGenerally speaking, corticosteroids constitute one of the cornerstones of treatment and are, with some exceptions, always used at least in the initial phase of the disease. In general, this involves oral corticosteroid therapy initiated between 0.5 and 1.5 mg\u002Fkg\u002Fday followed by a gradual decrease after 4 to 6 weeks of treatment. It is generally necessary to introduce immunosuppressive treatment early with the aim of avoiding corticosteroids. The most commonly used as first-line treatment and having shown effectiveness in observational studies are methotrexate, azathioprine, mycophenolate mofetil and calcineurin inhibitors. In general, rituximab is reserved for severe forms refractory to several first-line immunosuppressants, and has shown some effectiveness during a randomized study. Likewise, cyclophosphamide is only considered in the most severe forms, generally rapidly progressive interstitial lung damage. More recently, Janus kinase inhibitors have been evaluated in several open-label and small-number studies, showing interesting effectiveness, particularly for refractory forms, as shown in this recent review of the literature. Immunoglobulins are the only treatment that has shown superiority compared to placebo in good quality randomized controlled studies. However, due to their cost and difficulty of access, they should be reserved for the severe form, particularly in cases of dysphagia, or refractory form.\n\nApart from these medicinal treatments, it is necessary to add all the non-drug measures which are an integral part of the management of IIM. Performing regular physical activity helps prevent muscle loss and also has a beneficial effect on other comorbidities often present in patients and aggravated by corticosteroid therapy, such as cardiovascular risk factors, osteoporosis and resistance to 'insulin.",[30],[30,307,308,309],"Idiopathic Inflammatory Myopathy","Renal biopsy,","Guided kidney aspiration biopsy","2025-03-24",{"date":287,"type":37},{"date":313,"type":37},"2024-01-05",{"date":315,"type":21},"2025-12-05",{"name":317,"class":172},"University Hospital, Strasbourg, France",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":45},"100545265","an-clinical-study-of-yts109-cell-injection-in-subjects-with-recurrentrefractory-autoimmune-disease-100545265","NCT06379646","An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent\u002FRefractory Autoimmune Disease","An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Subjects With Recurrent\u002FRefractory Autoimmune Disease","Inclusion Criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.\n3. The functions of important organs meet the following requirements:\n\n   1. Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109\u002FL; Hemoglobin ≥60g\u002FL;\n   2. Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;\n   3. Renal function: creatinine clearance (CrCl) ≥30 ml\u002Fminute;\n   4. Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;\n   5. Heart function: good hemodynamic stability;\n4. Female subjects with fertility and male subjects whose partners are women of childbearing age are required to use medically approved contraception or abstinence during the study treatment period and at least 6 months after the end ofthe study treatment period; Female subjects of childbearing age tested negative for serum HCG within 7 days before enrollment in the study and were not in lactation.\n5. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nSpecific inclusion criteria:\n\nRecurrent refractory systemic lupus erythematosus\n\n1. Complies with the classification standards of the 2019 European Union Against Rheumatology\u002FAmerican Society of Rheumatology (EULAR\u002FACR) SLE;\n2. Disease activity score SELENA SLEDAI≥6 with at least one Injima Lupus Assessment Group Index (BILAG-2004) category A (severe presentation) or two Category B (moderate presentation) organ scores, or both; Or disease activity score SELENA SLEDAI score ≥8;\n3. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRecurrent refractory sjogren's syndrome\n\n1. Meet the 2002 AECG criteria for primary Sjogren's syndrome or the 2016 ACR\u002FEULAR classification criteria;\n2. Disease activity ESSDAI≥6;\n3. Positive anti-SSA \u002FRo antibody;\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRelapsing refractory\u002Fprogressive diffuse systemic sclerosis\n\n1. Meet the 2013 ACR classification criteria for systemic sclerosis;\n2. Positive antibodies related to systemic sclerosis;\n3. Diffuse sclerosis of the skin or active interstitial pneumonia (HRCT suggests ground glass exudation);\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept\n5. Definition of progression: rapid skin progression (mRSS increase \\>25%); Or progression of lung disease (a 10% reduction in FVC, or a more than 5% reduction in FVC with a 15% reduction in DLCO).\n6. Note: Articles 4 and 5 satisfy one or the other.\n\nRecurrent refractory\u002Fprogressive inflammatory myopathy:\n\n1. Meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including DM, PM, ASS and NM);\n2. Positive myositis antibody;\n3. Patients with muscle involvement had an MMT-8 score of less than 142 and abnormal findings on at least two of the following five core measures (PhGA, PtGA, extra-muscular disease activity score ≥2; HAQ total score ≥0.25; Muscle enzyme levels were 1.5 times the upper limit of the normal range); Or MMT-8≥142 with active interstitial lung disease (HRCT suggests ground glass exudation);\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept\n5. Definition of progressive: myositis aggravation or rapid progression of interstitial pneumonia.\n\nNote: Clauses 4 and 5 satisfy one or the other.\n\nRecurrent\u002Frefractory ANCA-associated vasculitis:\n\n1. Meet the 2022ACR\u002FEULAR diagnostic criteria for ANCA vasculitis, including microscopic polyvasculitis, granulomatous polyvasculitis, and eosinophilic granulomatous polyvasculitis.\n2. Anca-associated antibody positive (MPO-ANCA or PR3-ANCA positive);\n3. Birmingham vasculitis activity score (BVAS) ≥15 points (total 63 points), indicating vasculitis disease activity;\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRecurrent refractory\u002Fcatastrophic antiphospholipid syndrome:\n\n1. Meet the diagnostic criteria for primary antiphospholipid syndrome as revised in Sydney 2006;\n2. Positive titers of phospholipid antibodies (IgG\u002FIgM of LA, B2GP1 or acL, more than two positive tests within 12 weeks);\n3. Definition of relapse resistance: standard therapy with warfarin anticoagulant or replacement vitamin K antagonists (i.e., maintenance of the INR required for treatment) or with standard therapeutic dose of low molecular weight heparin (LMWH), as well as treatment of recurrent thrombosis with past hormones and cyclophosphamide;\n4. Catastrophic antiphospholipid syndrome needs to meet the following four criteria: (1) involvement of three or more organs, systems and\u002For tissues; (2) Symptoms appear within 1 week; (3) Histologically confirmed obstruction of small blood vessels in at least one organ or tissue; (4) aPL was positive.\n\nNote: Clauses 3 and 4 satisfy one or the other.\n\nExclusion Criteria:\n\n1. People with severe drug allergy or allergic constitution;\n2. the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;\n3. Subjects with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis as a result of the disease);\n4. Patients with cardiac dysfunction;\n5. Subjects with congenital immunoglobulin deficiency;\n6. History of malignant tumor in recent five years;\n7. Subjects with end-stage renal failure;\n8. Subjects with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis positive;\n9. Mental illness and severe cognitive impairment;\n10. Participants who had participated in other clinical trials within 3 months before enrollment;\n11. The duration of use of immunosuppressants that have therapeutic effects on the disease before enrollment was within five half-lives or biologics within four weeks;\n12. A woman who is pregnant or planning to become pregnant;\n13. The investigators believe that there are also subjects who could not be included in the study for other reasons.",{"count":326,"type":21},6,[328],"NA","An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent\u002Frefractory autoimmune disease",[27,57,30,31,32,29],"2024-08-27",{"date":333,"type":37},"2024-08-29",{"date":335,"type":37},"2024-04-24",{"date":337,"type":21},"2026-04-21",{"name":43,"class":44},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":45},"100548373","early-phase-1-the-safety-and-efficacy-of-anti-cd19-car-t-cells-in-patients-with-relapsedrefractory-autoimmune-diseases-100548373","NCT06420154","The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed\u002FRefractory Autoimmune Diseases","An Exploratory Clinical Study to Evaluating the Safety and Efficacy of Infusiing Anti-CD19-CAR-T Cells Injection (Anti-CD19-CAR-T Cells) in Patients With Relapsed\u002FRefractory Autoimmune Diseases","Common Inclusion Criteria:\n\n1. Voluntarily participate in clinical research. The person or legal guardian fully understands and informs the research and signs the informed consent form (ICF), and is willing to follow and complete all trial procedures;\n2. Aged 18-65 years old;\n3. ECOG score ≤ 2 points;\n4. Expected survival period is at least 12 weeks;\n5. Have good intravenous access (for apheresis) and have no other contraindications to blood cell separation;\n6. When screening patients, laboratory tests must meet the following requirements and they must not have received cell growth factors within 7 days before screening hematology assessment (long-acting colony-stimulating factor (G-CSF\u002FPEG-CSF) requires an interval of 2 weeks):\n\n\u003C!-- -->\n\n1. Absolute neutrophil count ≥1.0×10\\^9\u002FL;\n2. Hemoglobin ≥60 g\u002FL (without red blood cell transfusion within 14 days);\n3. Platelets ≥50×10\\^9\u002FL;\n4. Absolute lymphocytes (ALC) ≥ 0.5×10\\^9\u002FL;\n5. Serum total bilirubin ≤1.5×upper limit of normal (ULN);\n6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;\n7. Creatinine \\\u003C1.5×ULN and endogenous creatinine clearance ≥60 mL\u002Fmin. 7. The cardiac ejection fraction is ≥45%, echocardiography (ECHO) confirms that there is no pericardial effusion (except for a small amount or physiological), and the electrocardiogram results have no clinical significance; 8. Baseline oxygen saturation \\>92% under non-oxygenation conditions; 9. Women of childbearing age must have a negative serum or urine pregnancy test report (women who have undergone surgical sterilization or women who are at least 2 years postmenopausal are not considered women of childbearing potential).\n\nCommon Exclusion Criteria:\n\n1. Have active central nervous system diseases, such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;\n2. Fungal, bacterial, viral or other infections exist or are suspected and are not controlled or require intravenous antibiotic treatment; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed;\n3. Suffering from hepatitis B (hepatitis B virus surface antigen and hepatitis B DNA \\>1000 copies\u002Fml) or hepatitis C (positive hepatitis C antibody test); syphilis infection (antibody positive); human immunodeficiency virus (HIV) infection;\n4. Past medication:\n\n\u003C!-- -->\n\n1. CD19 targeted therapy;\n2. Inject live vaccines within 4 weeks before enrollment;\n3. Immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor) used within 4 weeks before enrollment;\n4. Use immunostimulatory or immune enhancer treatment (such as tacrolimus, cyclosporine, interferon-α, interferon-β, IL-2) within the 5 half-lives before apheresis;\n5. Have used systemic cytotoxic drugs within 2 weeks before enrollment, including daily or weekly low-dose maintenance chemotherapy (cyclophosphamide, ifosfamide, bendamustine, clotrexate or Melphalan, vincristine, etc.);\n6. Long-acting growth factors within 14 days before apheresis (such as pegfilgrastim) or short-acting growth factors within 5 days before apheresis or drugs used for cell mobilization (such as granulocyte colony-stimulating factor\u002Fnon- Gestin, Plexafor);\n7. The use of pharmacological doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided within 4 days before enrollment.\n\n5\\. Have a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina or other clinically significant heart diseases within 12 months before enrollment; 6. History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kosterman syndrome, Swachmann-Diamond syndrome, etc.; 7. History of symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment. Subjects need to take prophylactic anticoagulant drugs; 8. Have suffered from other malignant tumors in the past or at the same time (except for basal cell carcinoma of the skin, carcinoma in situ of the breast\u002Fcervix and other malignant tumors that have been effectively controlled without treatment in the past five years); 9. Use of other investigational pharmaceutical products within 30 days before screening; 10.Women of childbearing age who are pregnant or breastfeeding (because chemotherapy has potentially dangerous effects on the fetus or baby); 11.Male and female subjects who are unwilling to undergo birth control within 6 months from the signing of the informed consent form to the completion of the last administration of the study drug; 12.Any medical activity that may interfere with the evaluation of the safety or efficacy of the study; 13.According to the investigator's judgment, the subject is unlikely to complete all study visits or procedures required by the protocol, including follow-up visits or comply with the requirements for participation in the study; 14.Those who have used any CAR-T cell products or other genetically modified T cell therapies in the past.\n\nSpecific inclusion\u002Fexclusion criteria:\n\nRelapsed and refractory systemic lupus erythematosus： Inclusion criteria：\n\n1. Comply with the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) SLE classification criteria;\n2. In the moderate to severe active stage of the disease, SELENA-SLEDAI score \\>6;\n3. And have at least one British Island Lupus Assessment Group Index (BILAG-2004) Category A (severe performance) or two Category B (moderate performance) organ scores, or both;\n4. Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg\u002FKg\u002Fd) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide,tacrolimus,cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc.\n\nExclusion criteria:\n\n1. Combined with neuropsychiatric lupus;\n2. Thrombotic thrombocytopenic purpura (TTP)\u002Fmicrothrombotic vasculopathy (TMA).\n\nRelapsed and Refractory Sjogren's Syndrome Inclusion criteria：\n\n1. Meet the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary sjogren's syndrome;\n2. Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg\u002FKg\u002Fd) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc.\n\nExclusion criteria:\n\n1. Combined with liver cirrhosis;\n2. Combined with aplastic anemia (AA), myelodysplastic syndrome (MDS) or other myeloproliferative diseases (MPD);\n3. Drug-induced thrombocytopenia;\n4. Thrombotic thrombocytopenic purpura (TTP)\u002Fmicrothrombotic vasculopathy (TMA).\n\nRelapsed, Refractory\u002FProgressive Diffuse Scleroderma\n\nInclusion criteria： 1.Comply with the 2013 ACR classification criteria for scleroderma and comply with diffuse manifestations; 2.Combined with interstitial pneumonia: chest HRCT shows interstitial changes with ground glass exudation and the predicted value of FVC or DLCO in pulmonary function testing is \\\u003C70%; 3.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg\u002FKg\u002Fd) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.; 4.Definition of progress:\n\n1. Definition of skin progression: mRSS increase \\>10%;\n2. Definition of lung disease progression: FVC decreases by 10%, or FVC decreases by 5% and DLCO decreases by 15% (OMERACT progression).\n\n   Exclusion criteria:\n   1. New York heart function class IV;\n   2. There is moderate to severe pulmonary hypertension (mean pulmonary artery pressure on echocardiography \\>40 mmHg);\n   3. FVC \\\u003C45% predicted value;\n   4. DLCO \\\u003C40% predicted value;\n   5. Significant abnormalities on HRCT are not caused by SSc;\n   6. Persistent unexplained hematuria (5 red blood cells under high power) or creatinine clearance \\\u003C40ml\u002Fmin;\n   7. Patients who have had autologous stem cell transplantation in the past;\n   8. There are signs of renal crisis;\n   9. Active antral vasodilation.\n\n   Relapsed Refractory\u002FProgressive Inflammatory Myopathy\n\n   Inclusion criteria： 1.Comply with the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including DM, PM, ASS and NM); 2.For those with muscle involvement, the MMT-8 score is lower than 142 and there are at least two abnormal findings in the following five core measurements (PhGA, PtGA or extramuscular disease activity score ≥ 2 points; HAQ total score ≥ 0.25; muscle enzymes level is 1.5 times the upper limit of the normal range); 3.Myositis antibody positive; 4.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg\u002FKg\u002Fd) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc.\n\n   5.Definition of progressive: Rapidly progressive interstitial pneumonia occurring in a short period of time.\n\n   Exclusion criteria:\n   1. Drug-induced myositis\n   2. Inclusion body myositis;\n   3. Tumor-related myositis (myositis occurring within 2 years after tumor diagnosis).\n\n   Relapsed and Refractory ANCA-Associated Vasculitis\n\n   Inclusion criteria：\n\n   1.Meet the 2022 ACR\u002FEULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; 2.Positive ANCA-related antibodies (MPO-ANCA or PR3-ANCA positive); 3.Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis; 4.There must be at least one major item, at least 3 minor items, or at least two renal items in the BVAS assessment: hematuria and proteinuria; 5.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg\u002FKg\u002Fd) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.;\n\n   Exclusion criteria:\n\n   1.Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2; 2.If the patient has alveolar hemorrhage, invasive pulmonary ventilation is required and the duration is expected to exceed the screening time; 3.Dialysis or plasma exchange is required during the screening period; 4.Have received a kidney transplant.\n\n   Relapsed\u002FRefractory\u002FCatastrophic Antiphospholipid Syndrome\n\n   Inclusion criteria：\n   1. Meet the diagnostic criteria for primary antiphospholipid syndrome revised in Sydney in 2006;\n   2. Positive medium-to-high titer phospholipid antibodies (LA, B2GP1 or acL IgG\u002FIgM, more than two positive tests within 12 weeks);\n   3. Definition of relapse and refractory: use of warfarin anticoagulation or standard treatment instead of vitamin K antagonists (i.e., maintenance of the INR required for treatment) or use of standard therapeutic doses of low molecular weight heparin (LMWH), as well as use of hormones and cyclophosphamide treatment Recurrence of thrombosis;\n   4. Catastrophic antiphospholipid syndrome requires the following four criteria:\n\n   \u003C!-- -->\n\n   1. Involving three or more organs, systems and\u002For tissues;\n   2. Symptoms appear within 1 week;\n   3. Histology confirms small blood vessel obstruction in at least one organ or tissue;\n   4. aPL positive.\n\n   Exclusion criteria:\n   1. Obstetric APS;\n   2. APS merged with other CTDs;\n   3. APS involves the nervous system.",{"count":347,"type":21},9,[349],"EARLY_PHASE1","This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.",[56,29,57,30,352,32],"ANCA Associated Vasculitis",[354,285,355],"CAR T","Autoimmune Diseases","2024-05-14",{"date":358,"type":37},"2024-05-17",{"date":360,"type":21},"2024-05-27",{"date":362,"type":21},"2027-05-27",{"name":364,"class":172},"First Affiliated Hospital of Wenzhou Medical University",{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":372,"targetDuration":374,"studyType":139,"phases":4,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":4},"100514710","adult-idiopathic-inflammatory-myopathy-with-cardiac-injury-100514710","NCT05982041","Adult Idiopathic Inflammatory Myopathy With Cardiac Injury","A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury","Inclusion Criteria:\n\n* All patients who had a confirmed (muscular biopsy, electromyogram, magnetic resonance imaging) or suspected clinically myositis\n* Age over 18 years old\n* Signature of the informed consent form for the study\n\nExclusion Criteria:\n\n* Patients with disease duration \\>2 years\n* Patients \\\u003C 18 years\n* Confirmed non-inflammatory myopathies\n* Myositis secondary to alcohol or drug abuse\n* Patients unwilling or unable to give consent\n* Patients with poor or no venous access",{"count":373,"type":21},300,"30 Years","Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be collected for research purposes to measure a number of biomarkers for the assessment of diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR) muscle protocol will also be performed as per usual clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6-12 months. An existing electronic database entry system will be used for data entry and capture on an anonymised basis.",[30,377],"Cardiac Disease","2023-10-13",{"date":380,"type":37},"2023-10-17",{"date":382,"type":21},"2024-01-01",{"date":384,"type":21},"2043-01-01",{"name":386,"class":172},"The First Affiliated Hospital with Nanjing Medical University"]