[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antiphospholipid-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antiphospholipid-syndrome":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,41,68,99,128,173,201,220,257,281,306,332,353,380,404,428,452,471,494,514,534,559,579,600,630],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100093895","genetic-risk-factors-associated-with-antiphospholipid-antibody-syndrome-100093895",false,"NCT00482794","Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome","Genetics of Antiphospholipid Antibody Syndrome","APS","Inclusion Criteria:\n\n* Persistent presence of an antiphospholipid antibody, as defined by one or both of the following criteria:\n\n  1. Medium or high anticardiolipin antibody level in the blood on two or more occasions at least 6 weeks apart\n  2. Presence of lupus anticoagulant in the plasma on two or more occasions at least 6 weeks apart\n* Presence of clinical symptoms seen in patients with APS, including vascular thrombosis (one or more clinical episodes of arterial, venous, or small vessel thrombosis in any tissue or organ) and\u002For pregnancy morbidity, defined as any of the following:\n\n  1. One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, with normal fetus morphology documented by ultrasound or direct examination or the fetus\n  2. One or more premature births of a morphologically normal baby at or before the 34th week of gestation because of severe pre-eclampsia, eclampsia, or severe placental insufficiency\n  3. Three or more unexplained consecutive spontaneous abortions before the 10th week of gestation, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded\n* People who have elevated antiphospholipid antibody levels but do not fully meet clinical criteria for APS, and do have affected family members, will be considered for enrollment\n\nExclusion Criteria:\n\n* No documented presence of antiphospholipid antibody","ALL",{"count":20,"type":21},2800,"ESTIMATED","OBSERVATIONAL","Antiphospholipid antibody syndrome (APS) is characterized by the presence of antiphospholipid antibodies, which are proteins in the blood that interfere with the body's ability to perform normal blood clotting. Clinical problems associated with antiphospholipid antibodies include an increased risk for the formation of blood clots in the lungs or deep veins of the legs, stroke, heart attack, and recurrent miscarriages. It is possible that some people with APS have a genetic predisposition for developing the syndrome. This study will use a genetic strategy to identify potential inherited risk factors for the development of APS by recruiting people with APS who have family members also affected by the syndrome or by another autoimmune disorder, such as lupus or rheumatoid arthritis.",[25],"Antiphospholipid Syndrome",[27],"Antiphospholipid Antibody Syndrome","RECRUITING","2026-05-28",{"date":31,"type":32},"2026-05-29","ACTUAL",{"date":34,"type":4},"2006-06",{"date":36,"type":21},"2029-03",{"name":38,"class":39},"Duke University","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100382658","international-registry-of-thrombotic-aps-patients-treated-with-direct-oral-anticoagulants-100382658","NCT04262492","International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants","OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs","OBSTINATE","Inclusion Criteria:\n\n* Patient receiving a comprehensive information about the study, and not opposed to participate\n* Age ≥ 18 yo\n* Classification of definite APS according to revised Sapporo-Sydney criteria\n* Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months\n\nExclusion Criteria:\n\n* Incomplete revised Sapporo-Sydney criteria\n* No data regarding the recurrent thrombosis\n* Pregnant woman\n* Age \\\u003C 18 yo",{"count":50,"type":21},500,"5 Years","This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.",[25,54,55],"Thrombosis","Anticoagulants Causing Adverse Effects in Therapeutic Use",[57,58],"antiphospholipid syndrome","direct oral anticoagulants","2026-05-07",{"date":61,"type":32},"2026-05-08",{"date":63,"type":32},"2020-10-21",{"date":65,"type":21},"2031-04-21",{"name":67,"class":39},"Stéphane Zuily",{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":40},"100636809","point-of-care-testing-inr-in-antiphospholipid-syndrome-100636809","NCT07570511","Point of Care Testing INR in Antiphospholipid Syndrome","Explaining the Differences Between Capillary INR and Plasma INR in Patients With Antiphospholipid Syndrome","POCTAS","Inclusion Criteria:\n\n* Patients with APS treated with vitamin K antagonists (VKAs)\n\n  * Patients with an LA profile without aCL or anti-β2GPI (isolated LA)\n  * Patients with an LA and aCL + anti-β2GPI profile (triple positivity)\n  * Patients with another biological profile (other than isolated LA or triple positivity)\n* Control patients without aCL or anti-β2GPI treated with VKAs\n* Adult patients\n* Patients who have undergone a prior clinical examination appropriate for the research\n* Individuals who have received complete information on the organization of the research and have not objected to their participation and the use of their data\n* Patients covered by a social security scheme\n\nExclusion Criteria:\n\n* Patients with antiphospholipid syndrome (APS) not treated with vitamin K antagonists (VKAs)\n* Women of childbearing age without effective contraception\n* Persons covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code:\n\n  * Pregnant, parturient, or breastfeeding women\n  * Unemancipated minors\n  * Adults under legal protection (guardianship, curatorship, or protective supervision)","18 Years",{"count":78,"type":21},150,"INTERVENTIONAL",[81],"NA","Antiphospholipid syndrome (APS) is an autoimmune and prothrombotic disorder that can affect up to 10% of young people experiencing a thrombotic event. Its treatment relies on long-term anticoagulation with vitamin K antagonists (VKAs). Direct oral anticoagulants, which are simpler to use because they do not require regular blood monitoring, are contraindicated because they are associated with an increased risk of thrombotic recurrence in some patients with APS.\n\nPatients with APS receive VKAs and must regularly have their Index Normalized Ratio (INR) measured via a cumbersome venous blood draw. Capillary INR measurement systems are already used in certain situations, such as in patients with mechanical heart valves. The use of these systems improves the quality of life of these patients and, above all, the stability of VKA therapy, thus preventing potentially serious hemorrhagic complications or thrombotic recurrences.\n\nIn antiphospholipid syndrome (APS), these systems are discouraged due to perceived differences between capillary and venous INR (the reference method). However, among the few studies on the subject, none demonstrated significant discrepancies between patients with APS and controls, and when such discrepancies were observed, the origin of this variability could not be determined. We hypothesize that the biological profile of antiphospholipid antibodies is responsible for the INR differences.",[25,84],"Vitamine K Antagonist (VKA) Treatment",[86,87,88],"INR","vitamin K","Antiphospholipid","NOT_YET_RECRUITING","2026-04-30",{"date":92,"type":32},"2026-05-06",{"date":94,"type":21},"2026-06-01",{"date":96,"type":21},"2028-12-01",{"name":98,"class":39},"Central Hospital, Nancy, France",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":76,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100072565","predictors-of-pregnancy-outcome-in-systemic-lupus-erythematosus-sle-and-antiphospholipid-syndrome-aps-100072565","NCT00198068","Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)","PROMISSE","Inclusion Criteria:\n\n* Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies)\n* Patient between the ages of 18-45 and able to give informed consent, or age \\\u003C 18 years with parental consent\n* Hematocrit \\> 26%\n* For APL positive:\n\n  * aCL: IgG \\>= 40 GPL units; IgM \\>= 40 MPL units\n  * Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA)\n  * Anti-β2GPI: IgG \\>= 40 GPL units; IgM \\>= 40 MPL units\n* For control subjects:\n\n  * At least one successful pregnancy\n  * No history of fetal death (death of conceptus ≥ 10 weeks' gestation)\n  * No more than 1 miscarriage \\\u003C 10 weeks' gestation\n  * No history of positive aPL in local lab or positive aPL in core labs at screening\n  * Not currently a smoker\n  * No medical problems requiring chronic treatment\n\nExclusion Criteria:\n\n* Diabetes mellitus (Type I and Type II) antedating pregnancy\n* Known or suspected hereditary complement deficiency (defined by CH50 = 0)",true,"FEMALE","45 Years",{"count":110,"type":21},700,"The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and\u002For 2) to determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and\u002For SLE.",[113,25],"Systemic Lupus Erythematosus",[115,116,117],"Pregnancy outcomes","Systemic lupus erythematosus","Antiphospholipid syndrome","2026-04-23",{"date":120,"type":32},"2026-04-28",{"date":122,"type":4},"2003-09",{"date":124,"type":21},"2027-03",{"name":126,"class":39},"Hospital for Special Surgery, New York",10,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":106,"sex":18,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":79,"phases":140,"briefSummary":142,"conditions":143,"keywords":155,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701","NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment","12 Years","59 Years",{"count":139,"type":21},477,[141],"PHASE4","The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[144,145,146,147,148,149,150,151,152,153,25,154],"Rheumatoid Arthritis (RA)","Juvenile Idiopathic Arthritis (JIA)","Systemic Lupus Erythematosus (SLE)","Juvenile Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathies (IIMs)","Axial Spondyloarthritis","Psoriatic Arthritis (PsA)","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Takayasu Arteritis",[156,157,158,159,160,161,162],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","2026-04-14",{"date":165,"type":32},"2026-04-15",{"date":167,"type":21},"2026-03-16",{"date":169,"type":21},"2028-12-30",{"name":171,"class":39},"University of Sao Paulo General Hospital",2,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":79,"phases":183,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":40},"100611144","phase-1-an-exploratory-clinical-study-of-yts109-cell-for-rr-autoimmune-diseases-100611144","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.","65 Years",{"count":182,"type":21},18,[184],"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.",[113,187,188,189,190,25],"Lupus Nephritis (LN)","Sjogren's Syndrome","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","2026-03-02",{"date":193,"type":32},"2026-03-04",{"date":195,"type":32},"2025-11-24",{"date":197,"type":21},"2027-11-24",{"name":199,"class":200},"China Immunotech (Beijing) Biotechnology Co., Ltd.","INDUSTRY",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":178,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":180,"enrollmentInfo":207,"targetDuration":4,"studyType":79,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":172},"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":182,"type":21},[184],"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.",[146,211,212,189,190,25],"Systemic Sclerosis","Sjogren's Syndrome (SS)","2026-02-27",{"date":191,"type":32},{"date":216,"type":32},"2025-11-13",{"date":218,"type":21},"2027-11-13",{"name":199,"class":200},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":106,"sex":18,"minAge":76,"maxAge":226,"enrollmentInfo":227,"targetDuration":229,"studyType":22,"phases":4,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":40},"100393366","rheumatology-patient-registry-and-biorepository-100393366","NCT04402086","Rheumatology Patient Registry and Biorepository","Inclusion Criteria for Rheumatology Patients:\n\n* Patients ≥18 years old with a diagnosis of a rheumatic autoimmune disease including, but not limited to: adult onset Still's disease, ankylosing spondylitis, antiphospholipid syndrome, Behcet's disease, dermatomyositis, giant cell arteritis, mixed connective tissue disease, polymyalgia rheumatica, polymyositis, psoriatic arthritis, reactive arthritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease and vasculitis.\n* Receiving clinical care at Yale Rheumatology clinics\n\nExclusion Criteria for Rheumatology Patients:\n\n* Unable to provide informed consent\n* No patients will be excluded based on gender or ethnicity or pregnancy status.\n* Women who are currently pregnant will need to wait to donate a skin biopsy until after they deliver.\n* Patients allergic to lidocaine or epinephrine or have a history of impaired wound healing will not be able to donate a skin biopsy.\n\nInclusion Criteria for Healthy Volunteers:\n\n* Age ≥ 18 years old\n* No chronic skin conditions\n* No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)\n* Normal BMI\n\nExclusion Criteria for Healthy Volunteers:\n\n* Unable to provide informed consent.\n* Currently pregnant or nursing unless the study goal is to study pregnant or nursing woman.\n* Allergies to lidocaine or epinephrine (skin biopsies).\n* A history of impaired wound healing (skin biopsies).","99 Years",{"count":228,"type":21},5000,"10 Years","To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.",[232,233,234,235,236,25,113,237,238,239,240,241,242,243,244,245,211,246,188,247],"Rheumatic Diseases","Adult Onset Still Disease","Ankylosing Spondylitis","Psoriatic Arthritis","Reactive Arthritis","Behcet Disease","Dermatomyositis","Polymyositis","Giant Cell Arteritis","Lyme Disease","Mixed Connective Tissue Disease","Polymyalgia Rheumatica","Rheumatoid Arthritis","Sarcoidosis","Scleroderma","Undifferentiated Connective Tissue Diseases","2026-02-11",{"date":250,"type":32},"2026-02-13",{"date":252,"type":32},"2020-08-04",{"date":254,"type":21},"2030-06-01",{"name":256,"class":39},"Yale University",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":180,"enrollmentInfo":264,"targetDuration":4,"studyType":79,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":40},"100563292","anti-cd19-il-10il15-car-nk-cells-in-refractoryrelapsed-autoimmune-diseases-100563292","NCT06614270","Anti-CD19 IL-10\u002FIL15 CAR-NK Cells in Refractory\u002FRelapsed Autoimmune Diseases","Clinical Study of Core Blood-derived Anti-CD19 IL-10\u002FIL15 CAR-NK in the Treatment of Refractory\u002FRelapsed Autoimmune Diseases","Common inlcusion Criteria:\n\n1. Age 18-65 years old, male or female;\n2. Routine blood count: hemoglobin ≥60g\u002FL, white blood cell count ≥ 2.5×109\u002FL, neutrophil count ≥1.0×109\u002FL (no colony-stimulating factor treatment within 2 weeks before examination);\n3. Liver function: ALT ≤3×ULN, AST≤3×ULN, TBIL≤1.5×ULN;\n4. Coagulation function: international normalized ratio (INR) \\< 1.5×ULN, prothrombin time (PT) \\<1.5×ULN;\n5. Cardiac function: good hemodynamic stability;\n6. Female subjects of childbearing age must have a negative pregnancy test and agree to use effective contraception during the trial;\n7. Voluntarily participate in this study and sign the informed consent form, agreeing to participate in the follow-up as required.\n\nSLE Enrollment Criteria:\n\n1. patients meet the classification criteria of SLE;\n2. Refractory or relapsed cases classified as non-response to standard therapy or disease recurrence after remission. Standard treatment is defined as therapy with at least three agents, including glucocorticoids at a dose \\>1 mg\u002Fkg\u002Fday, together with at least two of the following immunomodulatory drugs administered for more than 6 months: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, iguratimod, antimalarials, and biologic agents, including rituximab, belimumab, or telitacicept.\n\nSystemic Sclerosis (SSc) Enrollment Criteria:\n\n1. Patients who meet the SSc classification criteria of the 2013 ACR\u002FEULAR and have a diagnosis of systemic sclerosis;\n2. the patient\\'s disease duration ≤ 60 months (defined as the onset of the first non-Raynaud\\'s symptoms);\n3. Patient-modified Rodnan skin score (mRSS) ≥10 at the baseline visit; or active interstitial lung disease (ILD): ground-glass opacity on high-resolution computed tomography (HRCT), pulmonary function suggestive of forced vital capacity (FVC) or diffusing capacity for carbon monoxide (DLCO) less than 70% predicted;\n4. A or B needs to be met:\n\nA. Refractory or relapsed cases classified as non-response to standard therapy or disease recurrence after remission. Standard treatment is defined as the use of glucocorticoids and cyclophosphamide, as well as any of the following immunomodulatory drugs, for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tocilizumab, etc.; B. Presence of progressive disease, specifically defined as, within the past 6 months: a) Progression of cutaneous involvement: more than 25% increase in mRSS; or b) progression of lung disease: 10% reduction in FVC, or 5% reduction in FVC with 15% reduction in DLCO.\n\nIdiopathic Inflammatory myopathy enrollment criteria:\n\n1. Diagnosis according to the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies, including dermatomyositis (DM), polymyositis (PM), antisynthetase antibody syndrome (ASS), and immune-mediated necrotizing myositis (IMNM);\n2. patients with muscle involvement with a manual strength test-8 (MMT-8) score less than 142 and at least 2 abnormalities in the following 5 core assessments: Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), Extramuscular Disease Activity Score ≥2 points, Health Assessment Questionnaire (HAQ) total score ≥0.25, muscle enzyme level ≥1.5×ULN); or MMT-8≥142 with active interstitial lung disease (HRCT suggests ground-glass opacities);\n3. Positive myositis-specific antibodies;\n4. A or B needs to be met:\n\nA. Relapsed or refractory patients: relapsed or reactive after remission. Definition of conventional treatment: 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: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tetatercept, etc.; B. Patients with progressive disease: rapid progressive interstitial pneumonia in a short period of time.\n\nANCA-associated vasculitis enrollment criteria:\n\n1. Meets the 2022 ACR\u002FEULAR ANCA-ASSOCIATED VASCULITIS CLASSIFICATION CRITERIA, INCLUDING MICROSCOPIC POLYANGIITIS (MPA), GRANULOMATOSIS WITH POLYANGIITIS (MPA);\n2. Positive PR3-ANCA or MPO-ANCA (either previous or current positive);\n3. Birmingham Vasculitis Activity Scale (BVAS) score of ≥ 15 points, and at least 1 major item caused by active vasculitis, or at least 3 non-major items, or at least renal involvement hematuria, proteinuria;\n4. estimated glomerular filtration rate (eGFR) ≥15 mL\u002Fminute\u002F1.73 m2 (MDRD method);\n5. Definition of refractory\u002Frelapsed: Conventional treatment that remains ineffective for more than 6 months, or disease recurrence after remission. Conventional treatment definition: use of glucocorticoids (more than 1 mg\u002Fkg\u002Fday) and cyclophosphamide, as well as any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tocilizumab, etc.\n\nSjögren\\'s syndrome enrollment criteria:\n\n1. Meet the 2002 European and American Consensus Group (AECG) standards or the 2016 ACR\u002FEULAR Primary Sjögren\\'s Syndrome (pSS) classification criteria;\n2. positive anti-SSA\u002FRo-60 antibody;\n3. Definition of disease activity: EULAR Sjögren\\'s Syndrome Disease Activity Index (ESSDAI) score ≥ 5;\n4. Definition of recurrence\u002Frefractory: Conventional treatment that remains ineffective for more than 6 months, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (\\>1 mg\u002Fkg\u002Fday) and cyclophosphamide, as well as any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab.\n\nAntiphospholipid syndrome enrollment criteria:\n\n1. Primary antiphospholipid syndrome meeting the 2006 Sydney criteria;\n2. Medium to high titer phospholipid antibody (aPL) positive: lupus anticoagulant (LA), IgG or IgM anti-β2 glycoprotein 1 antibody (anti-β2-GP1) or anticardiolipin antibody (aCL), at least 2 or more times positive, with an interval of more than 12 weeks;\n3. A or B needs to be met:\n\nA. Definition of refractory\u002Frelapsed: recurrent thrombosis with standard therapy with warfarin or other vitamin K antagonist coagulation (INR maintained within the range required for treatment), or standard therapeutic dose low molecular weight heparin (LMWH) with glucocorticoids and cyclophosphamide; B. Catastrophic antiphospholipid syndrome requires the following four criteria: (1) involvement of ≥ 3 organs, systems, and\u002For tissues (vascular embolism requires radiographic evidence, renal involvement requires a \\>50% increase in creatinine, blood pressure \\> 180\u002F100 mmHg, and\u002For urine protein \\>0.5 g\u002F24 hours); (2) all clinical manifestations appear simultaneously or sequentially within 1 week; (3) Pathological basis for the presence of small vessel occlusion in at least one organ or tissue (evidence of vascular embolism is required for pathological diagnosis, occasionally complicated by vasculitic manifestations); (4) Positive aPL antibody.\n\nCommon Exclusion Criteria:\n\n1. Combined with other connective tissue diseases;\n2. Involvement of important organs: heart (individuals with more severe heart disease, such as angina, myocardial infarction, heart failure, and arrhythmias), kidney (eGFR \\< 15 ml\u002Fmin\u002F1.73m2), liver (ALT\\>3×ULN, AST\\>3×ULN, TBIL \\>1.5×ULN), lung (FVC\\<50% predicted or hemoglobin-corrected DLCO\\<40% predicted), hematologic (leukocyte \\< 2.5×109\u002FL, neutrophil count \\<1.0×109\u002FL, HGB\\<60g\u002FL), etc.;\n3. Abnormal hepatitis B or hepatitis C test indicating active infection or chronic infection, including positive HBsAg or HBcAb test and positive hepatitis C antibody;\n4. Have active tuberculosis or latent tuberculosis;\n5. Human immunodeficiency virus (HIV) serology positivity or known history of HIV infection;\n6. Presence of any known serious active infection (including bacterial, viral, fungal, etc.), including those requiring hospitalization or intravenous antibiotic therapy within 4 weeks prior to screening and oral antibiotic therapy within 2 weeks prior to screening; Those who have various chronic infections and are currently receiving corresponding treatment, such as pneumocystosis, cytomegalovirus, herpes zoster, atypical mycobacteria, etc.;\n7. Patients with primary or secondary immunodeficiency;\n8. IgA deficiency (\\<10 mg\u002FdL) or IgG deficiency (\\<400 mg\u002FdL);\n9. Receiving other investigational drug treatment or participating in any other drug trial within 3 months before screening;\n10. History of documented and confirmed malignancy within 5 years prior to screening, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been appropriately treated or resected;\n11. Patients who are pregnant, breastfeeding, or planning a recent pregnancy, or who are unwilling to use a reliable contraceptive method of contraception for the duration of the study;\n12. Those who have been allergic to human or murine proteins and monoclonal antibodies in the past;\n13. Received live vaccine or live attenuated vaccine within 4 weeks prior to randomization;\n14. Patients who are not expected to comply with the requirements of the protocol or are not expected to complete the trial as planned (such as those with psychiatric disorders, history of alcoholism, drug or other substance abuse);\n15. Other conditions that the investigator considers the patient not suitable to enter the trial.\n\nSystemic Sclerosis Exclusion Criteria:\n\n1. Localized cutaneous SSc;\n2. the duration of the disease is greater than 5 years (defined as the onset of the first non-RP symptom);\n3. SSc-like syndrome related to environmental factors, such as vinyl chloride, bleomycin, etc.;\n4. Any history of scleroderma renal crisis;\n5. intermediate- and high-risk pulmonary hypertension;\n6. Active antral vasodilation.\n\nIdiopathic Inflammatory myopathy exclusion criteria:\n\n1. drug-induced myopathy;\n2. inclusion body myositis;\n3. Tumor-associated myositis (myositis occurring within 2 years of diagnosis of tumor).\n\nANCA-associated vasculitis exclusion criteria:\n\n1. alveolar hemorrhage, requiring invasive lung ventilation, which is expected to last longer than the screening time;\n2. Need for dialysis or plasmapheresis during screening;\n3. Have undergone a kidney transplant.\n\nSjögren\\'s syndrome exclusion criteria:\n\n1. Combined with liver cirrhosis;\n2. Combined with aplastic anemia (AA), myelodysplastic syndrome (MDS) or other myeloproliferative disorders (MPD);\n3. drug-induced thrombocytopenia;\n4. Thrombotic thrombocytopenic purpura (TTP)\u002Fmicrothrombotic vascular disease (TMA).\n\nAntiphospholipid syndrome exclusion criteria:\n\n1. Obstetric APS;\n2. APS incorporates other CTDs;\n3. APS involves the nervous system.",{"count":265,"type":21},15,[81],"This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10\u002FIL15 CAR-NK cells in patients with refractory\u002Frelapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.",[148,269,270,271,25,113],"ANCA Associated Vasculitis (AAV)","Idiopathic Inflammatory Myopathy (IIM)","Sjogren's Syndrome","2025-12-21",{"date":274,"type":32},"2025-12-29",{"date":276,"type":32},"2025-01-06",{"date":278,"type":21},"2027-01-06",{"name":280,"class":39},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":180,"enrollmentInfo":289,"targetDuration":4,"studyType":79,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":40},"100609265","a-study-of-cd19-ucar-t-cells-in-subjects-with-autoimmune-diseases-100609265","NCT07212322","A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases","A Study to Evaluate the Safety and Efficacy of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases","ET-902-AID01","Inclusion Criteria:\n\n* Male or female, between 18 and 65 years old;\n* Adequate organ functions, defined as follows:\n\nHematological function \\[no transfusion and no use of granulocyte colony-stimulating factor (G-CSF) administration within 2 weeks prior to testing\\]: white blood cells (WBC) ≥3.0×10\\^9\u002FL, absolute neutrophil count (ANC)≥1.0×10\\^9\u002FL, platelet count (PLT)≥50×10\\^9\u002FL (ITP subjects are without restrictions), hemoglobin ≥80 g\u002FL.\n\nCoagulation function: international normalized ratio (INR) ≤ 1.5×upper limit of normal value （ULN）, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\nHepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×(ULN), and total bilirubin ≤1.5×ULN. 4)Renal function: serum creatinine ≤1.5×ULN or creatinine clearance (calculated by Cockcroft Gault formula) ≥ 40 ml\u002Fmin.\n\nCardiac function: New York Heart Association (NYHA) Grade I or II, and left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography (ECHO), with no pericardial effusion, and no clinically significant abnormalities on12-lead electrocardiogram (ECG).\n\nPulmonary function: oxygen saturation ≥92% on room air (without supplemental oxygen), no clinically significant pleural effusion.\n\n* Subjects with fertile partners must agree to use effective contraception throughout the treatment period and for 24 months after treatment, and must refrain from donating eggs\u002Fsperm for assisted reproduction during this period; Female subjects of childbearing potential (excluding those who have undergone sterilization or ≥12 months of menopause) must have negative urine or blood pregnancy test results during screening.\n* Voluntary participates this trial and can comprehend and sign ICF.\n* For subjects with moderate to severe refractory Systemic Lupus Erythematosus:\n\nDiagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE.\n\nPositive for antinuclear antibody (ANA) (titer ≥1:80) and\u002For anti-dsDNA antibody and\u002For anti-Sm antibody at screening.\n\nSLEDAI-2000 score ≥8 at screening; if points are attributed for low complement and\u002For anti-dsDNA antibody, the SLEDAI-2000 clinical symptom score (excluding points for low complement and\u002For anti-dsDNA antibody) must be ≥6.\n\nA history of at least 6 months of stable standard treatment regimen prior to screening, with failure to achieve LLDAS criteria for at least 2 months before screening. Standard treatment regimen refers to stable use of any of the following medications (alone or in combination):\n\nglucocorticoids, antimalarials, biologics, and other immunosuppressants or immunomodulators.\n\n• For subjects with relapsed\u002Frefractory Systemic Systemic Sclerosis: Diagnosed with systemic sclerosis (SSc) according to the 2013 EULAR\u002FACR classification criteria for SSc.\n\nClassified as diffuse cutaneous or limited cutaneous subtype with a disease duration ≤7 years (from the first occurrence of Raynaud's phenomenon to screening).\n\nIf interstitial lung disease (ILD) is present at screening, forced vital capacity (FVC) must be ≥45% of predicted value, or diffusing capacity for carbon monoxide (DLCO) must be ≥40% of predicted value.\n\nRelapsed\u002Frefractory is defined as: failure to respond to prior conventional therapy or disease relapse after remission. Conventional therapy refers to the use of glucocorticoids combined with at least one immunosuppressive\u002Fimmunomodulatory drug for ≥6 months.\n\n• For subjects with refractory Idiopathic Inflammatory Myopathies: Diagnosed with idiopathic inflammatory myopathy (IIM) with a probability ≥55% according to the 2017 EULAR\u002FACR classification criteria for IIM, and classified as dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or anti-synthetase syndrome (ASyS) based on age at onset, cutaneous and muscle manifestations, laboratory findings, and muscle biopsy characteristics.\n\nDisease activity\u002Fseverity meets the following criteria: ①Manual Muscle Testing-8 (MMT-8) score ≤141 (total score 150). ②Meets at least two of the following additional abnormal CSMs: Patient Global Assessment of disease activity \\[based on Visual Analog Scale (VAS)\\] score ≥2 (range 0-10); Physician Global Assessment of disease activity VAS score ≥2 (range 0-10); Physician Global Assessment of extra-muscular disease activity VAS score ≥2 (range 0-10); HealthAssessment Questionnaire Disability Index (HAQ-DI) score ≥0.25 (range 0-3); At least one muscle enzyme level \\>1.5 times the upper limit of normal (ULN).\n\nPrevious intolerance or inadequate response to glucocorticoids and at least one immunosuppressant or immunomodulator for the aforementioned autoimmune disease, requiring: Treatment with glucocorticoids and at least one immunosuppressant at known effective doses for at least 3 months.\n\n• For subjects with relapsed\u002Frefractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: Clinically diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the definitions established at the 2012 Chapel Hill Consensus Conference (CHCC).\n\nMeet at least one major item or at least three other items in the Birmingham Vasculitis Activity Score (BVAS) version 3.\n\nTest positive for anti-proteinase 3 (PR3-ANCA) antibody or anti-myeloperoxidase (MPO-ANCA) antibody at screening.\n\nRelapsed\u002Frefractory is defined as: Relapsed AAV subjects: Disease relapse (defined as: presence of at least one major item or at least three other items in BVAS assessment, or occurrence of 1-2 new other items in two consecutive assessments) after achieving initial efficacy (BVAS score of 0 and glucocorticoid dose ≤7.5 mg\u002Fday prednisone or equivalent) following at least 3 months of treatment with glucocorticoids combined with immunosuppressants, with relapse occurring within 12 weeks prior to screening; Refractory AAV subjects: Failure to achieve efficacy (BVAS score of 0 and glucocorticoid dose ≤7.5 mg\u002Fday prednisone or equivalent) after at least 3 months of treatment with glucocorticoids combined with immunosuppressants.\n\n• For subjects with active Sjögren's Syndrome: Diagnosed with Sjögren's syndrome (SS) according to the 2016 EULAR\u002FACR classification criteria.\n\nUnstimulated whole salivary flow rate ≥0.05 mL\u002Fmin or stimulated whole salivary flow rate ≥0.01 mL\u002Fmin at screening.\n\nActive disease defined as: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5 points.\n\n• For subjects with refractory Antiphospholipid Syndrome: Diagnosed with antiphospholipid syndrome (APS) according to the 2006 Sydney Revised Classification Criteria for APS or the 2023 ACR\u002FEULAR Classification Criteria for APS; Positive for antiphospholipid antibodies (including lupus anticoagulant, anticardiolipin antibodies, and anti-β2 glycoprotein I antibodies) on at least two occasions \\>12 weeks apart; Presence of at least one non-criteria clinical manifestation, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valvular heart disease, and neurological manifestations.\n\n• For subjects with chronic\u002Frefractory Immune Thrombocytopenia: Diagnosed with immune thrombocytopenia (ITP) according to the Chinese Guideline for Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 Edition).\n\nPatients who previously received at least one guideline-recommended standard ITP treatment but exhibited inability to maintain response, relapse, intolerance to standard therapy, or insufficient response.\n\nChronic\u002Frefractory definition: Chronic: Persistent thrombocytopenia for ≥12 months; Refractory: Failure to respond to first-line therapies, thrombopoietin receptor agonists, and rituximab; or failure\u002Frelapse after splenectomy; with confirmed ITP diagnosis upon recent reassessment.\n\nExclusion Criteria:\n\n* Patients with a history or concurrent diagnosis of active malignancies, including tumor-associated polymyositis\u002Fdermatomyositis, are excluded. Exceptions include cured or non-recurrent cervical carcinoma in situ for at least 3 years, non-invasive basal cell or squamous cell skin cancer, or localized prostate cancer treated with radical therapy, or ductal carcinoma in situ after radical surgery.\n* Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products.\n* Patients with severe pulmonary diseases within the past year, such as moderate to severe pulmonary hypertension (pulmonary artery systolic pressure \\> 50 mmHg on echocardiography), or those requiring oxygen therapy via a reservoir mask or non-invasive\u002Finvasive mechanical ventilation during screening.\n* Patients who have received any of the following medications or treatments within the specified timeframes:\n\nB-cell-depleting therapy within 6 months before screening, assessed by the investigator as not having failed treatment, including anti-CD20, anti-CD22, anti-CD52, anti-CD38 or ant-BCMA monoclonal antibodies or bispecific antibodies.\n\nHigh-dose intravenous immunoglobulin (IVIG) within 3 months before screening. Dialysis or plasmapheresis within 2 months before screening. Glucocorticoid pulse therapy (defined as ≥ 200 mg\u002Fday prednisone or equivalent doses of other glucocorticoids) within 2 months before screening.\n\nUsed telitacicept within 6 weeks before screening, or belimumab within 8 weeks before screening.\n\nThrombopoietin (TPO) or TPO receptor agonists (TPO-RA) or any other medication with a clearly indicated platelet-boosting effect, ortransfusion therapy (including platelet transfusion) within 2 weeks before screening (ITP subjects are without restrictions).\n\n* Patients with a history of severe central nervous system (CNS) disorders history or related symptoms (excluding isolated trigeminal nerve disease) within the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular diseases, encephalitis, brain injury, aneurysm, cerebellar disorders, organic brain syndrome, Parkinson's disease as well as symptoms such as epilepsy, convulsion, aphasia, dementia.\n* Complicated with severe renal disease, defined as any of the following within 8 weeks before screening:\n\nSevere lupus nephritis \\[defined as urine protein \\> 6g\u002F24h or serum creatinine \\> 1.5×ULN.\n\nCreatinine clearance (Cockcroft Gault formula) \\\u003C 40mL\u002Fmin\\]. Active nephritis requiring treatment that are prohibited per protocol. Requiring hemodialysis or plasmapheresis, or receiving prednisone \\> 100mg\u002Fd or equivalent corticosteroid therapy ≥14 days.\n\n* Patients with severe allergies to any components of the lymphodepletion regimen or CD19 UCAR-T therapy used in this study.\n* Patients who meet any of the following criteria:\n\nPositive for hepatitis B surface antigen (HBsAg) AND positive for hepatitis B core antibody (HBcAb) with detectable HBV DNA in peripheral blood.\n\nPositive for hepatitis C virus (HCV) antibody with detectable HCV RNA. Positive for Treponema pallidum antibody. Positive for HIV antibody.\n\n* Patients with uncontrolled fungal, bacterial, or viral infections, or any other active infections are assessed as inappropriate to participate in the study by investigator .\n* Patients with a history of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n* Patients with active tuberculosis (TB) or latent TB infection (defined as positive tuberculin skin test or interferon-gamma release assay results without clinical symptoms or radiographic evidence) at screening;\n* Patients who have experienced any of the following cardiovascular events within 6 months before screening (including but not limited to):\n\nCongestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary\u002Fperipheral artery bypass grafting.\n\nSevere arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, etc.). Congenital long QT syndrome and left anterior fascicular block (bifascicular block). Asymptomatic right bundle branch block is permitted for enrollment.\n\nUncontrolled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\>100 mmHg), history of hypertensive crisis or hypertensive encephalopathy;\n\n* Patients with a history of autoimmune diseases (other than the target indications) that need systemic treatments, including but not limited to: eosinophilic granulomatous with polyangiitis (EGPA), Henoch-Schönlein purpura (HSP), rheumatoid arthritis, cryoglobulinemia vasculitis, inclusion body myositis, anti-glomerular basement membrane disease, Behcet's disease or Takayasu's arteritis, etc..\n* Patients with non-IIM conditions such as drug-induced myopathy, HIV-associated myopathy, thyroid myopathy, or a family history of myopathy.\n* History of catastrophic APS within 3 months prior to screening;\n* Pregnant or lactating women.\n* Patients who have received live vaccines within 6 weeks prior to lymphodepleting chemotherapy.\n* Patients who meet any of the following criteria:\n\nParticipate in other interventional clinical studies, and receipt of any investigational treatment within 3 months before signing the informed consent form.\n\nIntent to participate in another clinical trial during the entire study period. Plan to receive non-protocol-specified treatments for autoimmune diseases.\n\n* Patients with psychiatric disorders including depression or suicidal tendency.\n* Patients deemed by the investigator to have other factors that may make them unsuitable for participation or may affect their ability to complete the study.",{"count":290,"type":21},24,[81],"The purpose of this study is to assess the safety and efficacy of CD19 UCAR-T cell therapy in Subjects with autoimmune diseases.",[113,294,190,295,25,296,211],"Idiopahic Inflammatory Myopathies","Sjögren's Syndrome","Immune Thrombocytopenia","2025-12-18",{"date":299,"type":32},"2025-12-19",{"date":301,"type":21},"2026-01-30",{"date":303,"type":21},"2027-07-20",{"name":305,"class":39},"Institute of Hematology & Blood Diseases Hospital, China",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":79,"phases":315,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100616096","early-phase-1-clinical-study-of-bct301-cell-injection-therapy-for-refractory-autoimmune-diseases-100616096","NCT07301164","Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases","A Study of BCT301 (Anti-CD19 Chemically Induced Pluripotent Stem Cell (CiPSC)-Derived CAR-iT Cells) Therapy for Refractory Autoimmune Diseases","Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n1. Voluntarily sign the informed consent form.\n2. Male or female, aged 18-80 years (inclusive), with a body weight ≥40 kg.\n3. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the treatment period and for at least 6 months after the end of the treatment. Female participants of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to enrollment and must not be breastfeeding.\n4. Participants currently receiving one or more of the following treatments at stable doses: glucocorticoids, antimalarials, immunosuppressants:\n\n   1. If the participant is receiving glucocorticoid therapy, the following conditions must be met: the maximum dose at screening and during the screening period is 30 mg\u002Fday of prednisone (or equivalent). The dose must have been stable for ≥7 days prior to screening, and adjustments during the screening period must not exceed 5 mg\u002Fday of prednisone (or equivalent);\n   2. If the participant is receiving antimalarials and\u002For conventional immunosuppressants: the treatment must have been initiated ≥12 weeks prior to screening. The dose must have been stable for ≥8 weeks prior to screening and remain stable during the screening period;\n   3. If biological agents (belimumab, telitacicept, rituximab, etc.) were used prior to the screening period, a washout period of at least 5 half-lives must be completed before screening.\n5. Peripheral blood B cells must show positive CD19 expression as detected by flow cytometry.\n\nDisease-Specific Inclusion Criteria\n\n1\\. Systemic Lupus Erythematosus (SLE)\n\n1. Meet the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE.\n2. Have moderate to severe disease activity at screening, with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score \\>6.\n3. Have inadequate response to conventional therapy or experience disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n4. Have positive serological autoantibody tests: positive antinuclear antibodies (ANAs) and\u002For anti-ds-DNA antibodies and\u002For anti-Sm antibodies.\n\n2\\. Systemic Sclerosis (SSc)\n\n1. Meet the 2013 EULAR\u002FACR classification criteria for SSc.\n2. Fulfill either (a) or (b) below:\n\n   1. Inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n   2. Disease progression: skin progression with a modified Rodnan Skin Score (mRSS) ≥10; and\u002For interstitial lung disease evidenced by ground-glass opacities on high-resolution computed tomography (HRCT); a decline in forced vital capacity (FVC) ≥10%, or a decline in FVC ≥5% accompanied by a decline in diffusing capacity for carbon monoxide (DLCO) ≥15%.\n3. Have positive SSc-related autoantibodies. 3. Antiphospholipid Syndrome (APS)\n\n1\\) Meet the 2006 Sydney criteria for primary antiphospholipid syndrome. 2) Have medium to high titers of antiphospholipid antibodies (lupus anticoagulant \\[LA\\], anti-β2-glycoprotein 1 \\[β2GP1\\] IgG\u002FIgM, or anti-cardiolipin \\[aCL\\] IgG\u002FIgM); 3) Fulfill either (a) or (b) below:\n\n1. Receiving standard treatment with warfarin or alternative vitamin K antagonists (maintaining target international normalized ratio \\[INR\\]), or standard therapeutic doses of low molecular weight heparin (LMWH), and\u002For glucocorticoids and immunosuppressants\u002Fbiologics (e.g., cyclophosphamide, cyclosporine, tacrolimus, rituximab, etc.).\n2. Meet all four criteria for catastrophic APS:\n\ni) Involvement of three or more organs, systems, and\u002For tissues; ii) Development of manifestations within one week; iii) Histopathological confirmation of small vessel occlusion in at least one organ or tissue; iv) Positive antiphospholipid antibodies (aPL).\n\n4\\. Inflammatory Myopathy (IM)\n\n1. Meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including dermatomyositis, polymyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy).\n2. Have positive myositis-specific autoantibodies.\n3. For participants with muscle involvement: a Manual Muscle Test-8 (MMT-8) score \\\u003C142, and at least two of the following five core abnormalities: Physician Global Assessment ≥2, Patient Global Assessment ≥2, or extramuscular disease activity score ≥2; Health Assessment Questionnaire (HAQ) total score ≥0.25; muscle enzyme levels ≥1.5 times the upper limit of normal; or MMT-8 ≥142 but with active interstitial lung disease (ground-glass opacities on HRCT).\n\n5\\. Sjögren's Syndrome (SS)\n\n1. Meet the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome.\n2. Have a EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5.\n3. Have positive anti-SSA\u002FRo antibodies.\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\n6\\. Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)\n\n1. Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis (AAV), including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Have a history of or currently positive ANCA.\n3. Have a Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63).\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\nExclusion Criteria:\n\nStudy participants who meet any of the following criteria will be excluded from the study:\n\n1. Any medical condition that, in the opinion of the investigator, would contraindicate participation in the study, such as a life-threatening illness.\n2. Decreased organ function reserve not attributable to the primary disease:\n\n   a) Neutrophil count \\\u003C1×10⁹\u002FL; lymphocyte count \\\u003C0.3×10⁹\u002FL; hemoglobin \\\u003C70 g\u002FL; platelet count \\\u003C50×10⁹\u002FL; b) Alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN); aspartate aminotransferase (AST) \\>3 × ULN; total bilirubin \\>2 × ULN; c) Creatinine clearance \\\u003C40 mL\u002Fmin; estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²; or serum creatinine \\>2.5 mg\u002FdL; d) Left ventricular ejection fraction (LVEF) \\\u003C45% as measured by echocardiography; e) Oxygen saturation \\\u003C92% on room air.\n3. History of alcohol or substance abuse within the past 24 weeks.\n4. History of malignancy other than B-cell lymphoma.\n5. Presence of infections including human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency, syphilis, chronic hepatitis B or C, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n6. Known active tuberculosis (TB) infection or active bacterial infection.\n7. History of myocardial infarction, coronary angioplasty or stenting, unstable angina, clinically significant arrhythmia, or other clinically significant cardiac disease within 6 months prior to screening.\n8. Symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening, except in cases of antiphospholipid syndrome (APS).\n9. History of severe allergic reaction to any component of cellular therapy or other immunotherapeutic agents.\n10. Prior organ transplant requiring ongoing immunosuppressive therapy.\n11. Concurrent participation in another clinical trial that may interfere with disease assessment or study treatment.\n12. Prior treatment with CD19- and\u002For BCMA-targeted therapy or any CAR-T cell product; except in cases where prior therapy is deemed to have clearly failed (e.g., no response, short duration of response, or disease progression) as assessed by the investigator, the current disease state warrants the study treatment, and there is no clear evidence that toxicity from prior therapy would compromise the safety of the current study.\n13. Severe psychiatric disorder or significant cognitive impairment.\n14. Pregnancy, lactation, or planned pregnancy.\n15. Any other condition that, in the judgment of the investigator, would make the participant unsuitable for enrollment in this clinical trial.","80 Years",{"count":127,"type":21},[316],"EARLY_PHASE1","This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.",[319,148,320,25,321,322],"System Lupus Erythematosus","Inflammatory Myositis","ANCA Associated Vasculitis","Sjogren Syndrome","2025-12-09",{"date":325,"type":32},"2025-12-24",{"date":327,"type":21},"2025-12-11",{"date":329,"type":21},"2028-12-31",{"name":331,"class":39},"Peking University Third Hospital",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":16,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":338,"maxAge":76,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":40},"100103921","register-for-pediatric-patients-with-antiphospholipid-syndrome-aps-european-project-extended-internationally-study-100103921","NCT00616317","Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study","Inclusion Criteria:\n\n* 18 years of age or younger at the onset of disease\n* Presence of Vascular Thrombosis\n* UC Davis patient\n* Presence of at least one Laboratory criteria including: Anticardiolipin antibody, Anti-B glycoprotein-I antibody or Lupus anticoagulant in plasma\n\nExclusion Criteria:\n\n* Infants born to mothers with APS\n* Infants with congenital thrombophilia","1 Minute",{"count":340,"type":21},50,"The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome.",[25],[25],"2025-12-03",{"date":346,"type":32},"2025-12-05",{"date":348,"type":4},"2006-09",{"date":350,"type":21},"2040-01",{"name":352,"class":39},"University of California, Davis",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":359,"targetDuration":360,"studyType":22,"phases":4,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":379},"100488921","registry-on-augmented-antithrombotic-treatment-regimens-for-patients-with-arterial-thrombotic-aps-100488921","NCT05646394","Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS","Inclusion Criteria:\n\n1. Patients of at least 18 years of age with confirmed antiphospholipid syndrome according to Sydney criteria and with first or recurrent arterial thrombotic manifestation, including those with asymptomatic brain infarcts on diagnostic imaging.\n2. Treatment with either A) a vitamin K antagonist (VKA) with therapeutic range, international normalized ratio (INR) 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0 or C) VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen, if considered appropriate by the treating physician.\n3. Signed informed consent obtained (in jurisdictions where required).\n\nExclusion Criteria:\n\n1. Inability to follow the patient due to geographical or other reasons.\n2. Patients with documented poor compliance.\n3. Bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe.\n4. Pregnancy or planned pregnancy.\n5. Venous thrombotic event diagnosed after the last arterial event.",{"count":78,"type":21},"2 Years","The goal of this registry is to gather more information on the efficacy and safety of various antithrombotic regimens. The registry collects data on patients with antiphospholipid syndrome and an arterial event within the past 12 months, on treatment with either A) a VKA with therapeutic range, INR 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0, C) a VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen. The follow-up is 2 years.",[25,363],"Arterial Thrombosis",[365,366,367,368,369,370],"anticoagulation","vitamin K antagonist","antiaggregant","stroke","myocardial infarction","hemorrhage","2025-12-02",{"date":323,"type":32},{"date":374,"type":32},"2022-07-01",{"date":376,"type":21},"2029-12-31",{"name":378,"class":39},"McMaster University",3,{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":40},"100612253","characterization-of-autoreactive-b-lymphocytes-in-autoimmune-diseases-and-immune-deficiencies-100612253","NCT07251179","Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies","AutoB-Tetramer","Inclusion Criteria:\n\n* Patients aged between 18 and 70\n* Patients for whom at least one of the following conditions has been confirmed:\n* Systemic lupus erythematosus meeting the 2019 ACR\u002FEULAR classification criteria.\n* Systemic scleroderma meeting the 2013 ACR\u002FEULAR classification criteria. ANCA-associated vasculitis according to the 2022 EULAR\u002FACR classification criteria.\n* Antiphospholipid syndrome according to the 2023 ACR\u002FEULAR criteria.\n* Primary immunodeficiencies according to IUIS criteria.\n* Patients capable of understanding the objectives of the research.\n* Patients affiliated with a social security health insurance scheme (beneficiary or dependant).\n* Patients who have signed and dated the informed consent form for non-identifying genetic testing.\n\nExclusion Criteria:\n\n* Patient refusing to participate in the study\n* Patient in a period of exclusion (determined by a previous or ongoing study) Inability to provide the subject with informed consent (in an emergency or immediate life-threatening situation, difficulties in understanding the subject, etc.)\n* Patient under legal protection\n* Patient under guardianship or conservatorship","70 Years",{"count":389,"type":21},200,"Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase. Many AIDs are linked to the emergence of autoreactive B cells (BCs) directed against components of the self. In healthy individuals, these autoreactive B cells are counter-selected or regulated before reaching the antibody-secreting cell compartment. However, in predisposed individuals, a breakdown in B cell tolerance can occur, leading to the formation of autoantibodies with devastating consequences, such as the emergence of systemic lupus erythematosus (SLE), rheumatoid arthritis, and vasculitis. B-cell depletion is often beneficial in these patients, but paradoxically, therapies targeting B cells are not always effective. Furthermore, B cell depletion via LB-specific antibodies (anti-CD20) or treatment with CD19 chimeric antigen receptor T cells (CAR T) leads to complete and prolonged depression of the entire B compartment without targeting the LB population responsible for the onset of the disease. To date, two pitfalls in studies of human autoreactive LBs often complicate the interpretation of results:\n\ni) the difficulty of identifying autoreactive LBs among all LBs, ii) demonstrating the pathogenicity of autoreactive B lymphocytes when they can be identified individually. We propose to quantify and phenotype these autoreactive\u002Fpathogenic B cells using high-throughput flow cytometry in several clinical situations.",[113,392,393,25,394],"Systemic Scleroderma","ANCA-associated Vasculitis","Primary Immunodeficiencies","2025-11-26",{"date":397,"type":32},"2025-12-04",{"date":399,"type":21},"2026-01-01",{"date":401,"type":21},"2031-12-31",{"name":403,"class":39},"University Hospital, Strasbourg, France",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":180,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":79,"phases":414,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":40},"100605501","prevalence-and-consequences-of-antiphospholipid-syndrome-in-patients-aged-65-and-over-with-ischemic-strokes-is-100605501","NCT07163338","Prevalence and Consequences of Antiphospholipid Syndrome in Patients Aged 65 and Over With Ischemic Strokes (IS)","A Prospective, Single-center Cohort Study to Determine the Prevalence and Consequences of Antiphospholipid Syndrome in Patients Aged 65 and Over With Ischemic Strokes (IS)","SAPLAGE","inclusion criteria :\n\n* patients aged 65 and over during the inclusion phase\n* hospitalized for a TIA\u002Fischemic stroke in neurology or internal medicine department during the inclusion phase\n* affiliated with social security system exclusion criteria :\n* patients under 65 years old\n* under legal guardianship, curatorship, or tutorship\n* incarcerated\n* under psychiatric care\n* admitted to a healthcare or social institution",{"count":413,"type":21},400,[81],"Stroke represents a major cause of morbidity and mortality despite significant progress in recent decades. In individuals under the age of 65, the etiologies of ischemic stroke (IS) are diverse, and management is well-established. Antiphospholipid syndrome (APS) accounts for 10 to 20% of the causes of stroke in this population. In elderly individuals, APS is not systematically investigated due to the predominance of embolic, atherosclerotic, and small vessel disease causes. However, delayed discovery of APS is not uncommon and is more frequently associated with the occurrence of arterial thrombosis. Moreover, the management of APS involves several challenges given the risk of recurrence of thrombosis and the potential association with conventional cardiovascular risk factors. The antithrombotic treatment consists of lifelong anticoagulation, excluding direct oral anticoagulants (DOACs) due to the risk of thrombotic recurrence. The main objective of the study will be to assess the prevalence of antibodies useful for the diagnosis of APS (Sapporo criteria) in individuals aged 65 or older hospitalized for an ischemic stroke (IS) or transient ischemic attack (TIA).\n\nFurthermore, the classification of APS is likely to evolve in the coming years with the inclusion of new clinically relevant antibodies (anti-phosphatidylserine and anti-phosphatidylethanolamine) because of their strong association with the occurrence of thrombosis. Even though they are often associated with circulating anticoagulants, they are also found in 10% of APS cases negative for other antibodies.\n\nPatient inclusion in the study should occur during the acute phase of the stroke, before the initiation of anticoagulant treatment.\n\nThus, after verifying the inclusion and exclusion criteria, patients will be informed and must sign the informed consent form if they agree to participate.\n\nAfter inclusion, the research procedure will be as follows:\n\n* Conduct a unique immunological biological assessment with:\n\n  * Part performed as part of standard care: circulating anticoagulants, anti-cardiolipin antibodies, and anti-β2-glycoprotein type 1.\n  * Part performed specifically for the study (3.5 mL of additional blood): anti-phosphatidylserine and anti-phosphatidylethanolamine antibodies. The search for these antibodies will be performed using the 7mL dry tube collected for anti-cardiolipin and anti-β2-glycoprotein type 1 antibody testing.\n  * If the diagnostic sample is positive for any of these antibodies, a follow-up at 3 months is recommended and will be performed as part of standard care to confirm the APS diagnosis.\n* Data collection will include patient details, stroke\u002FTIA details, biological data, and follow-up. As part of routine follow-up, patients will be seen in a neurological consultation at 6 months.\n\nClinical and biological data will be reviewed at the end of the study by two doctors (a neurologist and an internist) to confirm or exclude the APS diagnosis and its contribution to the neurological condition.\n\nAn internal medicine follow-up will be initiated for patients with confirmed APS, and an appropriate treatment will be proposed.",[25],[117,418,368,419],"antiphospholipid antibody syndrome","ischemic stroke",{"date":421,"type":32},"2025-11-25",{"date":423,"type":32},"2025-09-16",{"date":425,"type":21},"2028-03-16",{"name":427,"class":39},"CHU de Reims",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":106,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":79,"phases":437,"briefSummary":438,"conditions":439,"keywords":440,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":40},"100544825","evaluation-of-cell-membrane-expression-of-annexin-a2-on-monocytes-by-flow-cytometry-in-primary-antiphospholipid-syndrome-100544825","NCT06373926","Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome","MONOCYTAN","Inclusion Criteria:\n\n* APS patients who fulfilled the revised criteria for APS\n\nExclusion Criteria:\n\n* Patients less than 18 years old\n* Solid and hematological malignancies\n* Other autoimmune diseases\n* Cirrhosis",{"count":436,"type":21},60,[81],"Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator, plays a pivotal role in regulation of fibrinolysis in vitro and in vivo and has been identified as a new autoantigen in antiphospholipid syndrome (APS). ANXA2 can exist as a monomer or a heterotetrameric complex with S100A10 protein. The aim of this study was to evaluate the cell membrane expression of ANXA2 on circulating monocytes in APS by flow cytometry. Several pathogenic mechanisms are involved in APS such as activation of endothelial cells, platelets and monocytes, inhibition of the natural anticoagulant protein C\u002Fprotein S pathway, activation of the complement system and also impairment of fibrinolysis. Annexin A2 which hits binding partner S100A10, ANXA2 forms a cell surface complex that regulates generation of plasmin. ANXA2 is involved in the pathogenesis of APS-associated through several possible mechanisms. Human peripheral blood monocytes represent the major circulating ANXA2-expressing cell and ANXA2-mediated assembly of plasminogen and tissue activator of plasminogen (tPA) on monocyte\u002Fmacrophages contributes to plasmin generation. Thus the investigators could suppose that decrease of cell membrane expression of ANXA2 on circulating monocytes represent a new pathogenic mechanism in APS.",[25],[441,57,442],"annexin A2","monocytes","2025-11-17",{"date":445,"type":32},"2025-11-19",{"date":447,"type":32},"2025-02-05",{"date":449,"type":21},"2026-03",{"name":451,"class":39},"Centre Hospitalier Universitaire, Amiens",{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":4},"100603878","hematological-markers-mpv-plr-and-nlr-in-primary-versus-secondary-antiphospholipid-syndrome-100603878","NCT07142239","Hematological Markers MPV, PLR, and NLR in Primary Versus Secondary Antiphospholipid Syndrome","Comparative Analysis of Hematological Markers MPV, PLR, and NLR in Primary Versus Secondary Antiphospholipid Syndrome","Inclusion Criteria:\n\n* Adults (age ≥18 years)\n* Diagnosis of APS based on updated Sydney classification criteria confirmed by: Clinical history of thrombosis and\u002For pregnancy morbidity, Persistent presence (≥12 weeks) of antiphospholipid antibodies (aCL, anti-β2-glycoprotein I, and\u002For lupus anticoagulant)\n\nExclusion criteria:\n\n* Current infection or inflammatory condition unrelated to APS\n* Hematological malignancies or other blood disorders\n* Recent blood transfusion or platelet-altering medications other than APS treatments",{"count":78,"type":21},"Antiphospholipid syndrome is a thrombo-inflammatory autoimmune disorder with a complex antiphospholipid antibody-mediated pathogenesis, and high heterogeneity in clinical presentation and disease course. Clinical presentation in antiphospholipid syndrome includes venous and arterial thrombosis, pregnancy complications, and a broad range of microvascular and non-thrombotic manifestations",[25],"2025-08-19",{"date":464,"type":32},"2025-08-26",{"date":466,"type":21},"2025-11-27",{"date":468,"type":21},"2027-06-30",{"name":470,"class":39},"New Valley University",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":313,"enrollmentInfo":478,"targetDuration":4,"studyType":79,"phases":480,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":40},"100579726","phase-1-safety-and-efficacy-of-universal-cd19-targeting-car-t-cells-in-refractory-autoimmune-diseases-100579726","NCT06828042","Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases","A Single-center Clinical Study Evaluating the Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells（QH103） in Refractory Autoimmune Diseases","Inclusion Criteria:\n\nCommon Inclusion Criteria:\n\n1. Age between 18-80 years (inclusive), male or female.\n2. Positive expression of CD19 on peripheral blood B cells by flow cytometry.\n3. Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.\n4. Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg\u002Fday prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed \\>5 mg\u002Fday prednisone (or an equivalent dose). If the subject is receiving antimalarials and\u002For conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.\n5. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.\n6. Willing to participate in the trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\n1. Systemic Lupus Erythematosus (SLE):\n\n   * Meets the 2019 EULAR\u002FACR classification criteria for SLE.\n   * ANA titer ≥1:80, or positive for anti-dsDNA and\u002For anti-Sm antibodies.\n   * Disease activity score (SLEDAI-2000) ≥8.\n2. Sjögren's Syndrome:\n\n   * Meets the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome.\n   * Disease activity score (ESSDAI) ≥5.\n   * Positive for anti-SSA\u002FRo antibodies.\n3. Systemic Sclerosis (SSc):\n\n   * Meets the 2013 EULAR\u002FACR classification criteria for systemic sclerosis.\n   * Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.\n   * At screening, mRSS \\>10; and\u002For active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) \\\u003C70% of predicted values.\n4. Idiopathic Inflammatory Myopathies (IIM):\n\n   * Meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).\n   * For patients with muscle involvement: a. MMT-8 score \\\u003C142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25. Muscle enzyme levels ≥1.5 times the upper normal limit. b. Alternatively, MMT-8 ≥142 but with active ILD (HRCT showing ground-glass opacities).\n   * Positive for myositis-specific antibodies.\n5. ANCA-Associated Vasculitis (AAV):\n\n   * Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.\n   * Positive for ANCA antibodies (current or historical).\n   * Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.\n6. Refractory Antiphospholipid Syndrome (APS):\n\n   * Meets the 2023 ACR\u002FEULAR diagnostic criteria for antiphospholipid syndrome.\n   * Positive for medium-to-high titers of antiphospholipid antibodies (LA, anti-β2-GP1, or ACL IgG\u002FIgM), with at least two positive results within 3 months.\n   * Definition of refractory APS: Disease remains active or relapses after remission, despite 6 months of conventional therapy, including: Anticoagulants (warfarin or standard treatment with vitamin K antagonists maintaining target INR) or low-molecular-weight heparin at standard doses. Glucocorticoids and\u002For immunosuppressants.\n   * Catastrophic APS (CAPS): Must meet all four criteria: a. Involvement of three or more organs, systems, and\u002For tissues. b. Symptoms occurring within one week. c. Histological evidence of small vessel occlusion in at least one organ or tissue. d. Positive for antiphospholipid antibodies (aPL).\n\nNote: Meeting either criterion 3 or 4 is sufficient. Patients with thrombocytopenia may not require anticoagulant therapy.\n\nExclusion Criteria:\n\n1. History of severe drug allergies or allergic constitution.\n2. Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n3. Central nervous system (CNS) diseases caused by autoimmune or non-autoimmune conditions, including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis.\n4. Dysfunction of major organs not meeting the following criteria (exceptions allowed if abnormalities are caused by autoimmune disease): a. Bone marrow function: White blood cell count ≥3×10⁹\u002FL. Neutrophil count ≥1×10⁹\u002FL (without GSF treatment within 2 weeks prior to testing). Hemoglobin ≥60 g\u002FL. Platelet count ≥50×10⁹\u002FL. b. Liver function: ALT ≤3×ULN (exceptions for ALT elevation caused by inflammatory myopathy). AST ≤3×ULN (exceptions for AST elevation caused by inflammatory myopathy). IBIL ≤1.5×ULN (exceptions for Gilbert's syndrome). Total bilirubin ≤3.0×ULN. c. Renal function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin (calculated using the Cockcroft\u002FGault formula, exceptions for acute CrCl decline caused by the disease itself). d. Coagulation function: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN. e. Cardiac function: Stable hemodynamics.\n5. Subjects with congenital immunoglobulin deficiencies.\n6. History of malignancy within the past five years.\n7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA levels exceeding the detection limit; positive hepatitis C virus (HCV) antibodies with detectable HCV RNA in peripheral blood; positive HIV antibodies; or positive syphilis test results.\n8. Subjects with psychiatric disorders or severe cognitive impairment.\n9. Participation in other clinical trials within 3 months prior to enrollment.\n10. Previous treatment with CAR-T therapy.\n11. History of severe adverse reactions to cyclophosphamide or fludarabine.\n12. Any other reason that the investigator determine that subjects cannot be included in this study.",{"count":479,"type":21},9,[184,481],"PHASE2","Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS). They affect the quality of life, while in severe cases, they can be life-threatening. Additionally, they impose a heavy economic burden on society. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy.\n\nChimeric Antigen Receptor (CAR)-T cells targeting the B cell surface molecule CD19 have achieved significant clinical progress in acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma, with several CD19 CAR-T therapies approved for marketing worldwide. Increasingly, clinical studies are exploring the use of CD19 CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated.\n\nIn this study, the investigators used γδ T cells as carrier cells to investigate the safety and efficacy of universal CAR-γδ T cells in the treatment of autoimmune diseases.",[484,148,322,269,485,25],"Systemic Lupus Erthematosus","Inflammatory Myopathies","2025-08-14",{"date":488,"type":32},"2025-08-20",{"date":490,"type":32},"2025-07-01",{"date":492,"type":21},"2027-12-31",{"name":331,"class":39},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":79,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":40},"100514857","phase-2-anti-cd38-antibody-treating-aps-with-thrombocytopenia-100514857","NCT05983952","Anti-CD38 Antibody Treating APS With Thrombocytopenia","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia","Inclusion Criteria:\n\n* Age 18 and above, male or female.\n* Conform to the diagnostic criteria of antiphospholipid syndrome (APS).\n* Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab, CSA or CTX etc., or those who cannot chose other second-line therapy.\n* Platelet count of \\\u003C30 X 10\\^9\u002FL.\n* With normal hepatic and renal functions.\n* ECOG physical state score ≤ 2 points.\n* Cardiac function of the New York Society of Cardiac Function ≤ 2.\n* Signed and dated written informed consent\n\nExclusion Criteria:\n\n* Received any treatment of anti-CD38 antibody drug\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;\n* HIV positive;\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;\n* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);\n* Patients with septicemia or other irregular severe bleeding;\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.",{"count":127,"type":21},[481],"To evaluate the safety and efficacy of anti-CD38 antibody in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and\u002For TPO-RA.",[25,505],"Thrombocytopenia","2025-07-31",{"date":508,"type":32},"2025-08-05",{"date":510,"type":32},"2023-08-01",{"date":512,"type":21},"2025-08",{"name":305,"class":39},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":180,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":40},"100544754","negative-antiphospholipid-syndrome-a-multicentric-study-100544754","NCT06373003","Negative Antiphospholipid Syndrome: a Multicentric Study","INCLUSION CRITERIA:\n\n1. Group 1 \\[APS\\]: Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS)\n2. Group 2 \\[SN-APS\\]: patients with seronegative APS (SN-APS): with clinical criteria (thrombotic or obstetric) for APS, persistently negative for aPL, and with clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases)\n3. Group 3: patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases).\n4. Age \\\u003C 65 years (at event time)\n5. Less than 5 years from the first even\n\nEXCLUSION CRITERIA\n\n1. Group 2 and 3: patients with a known cause of thrombosis or obstetrical manifestations\n2. Deceased patients\n3. Less than 5 years from the first event",{"count":521,"type":21},105,"Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.\n\nThe main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin\u002Fcardiolipin and anti-phosphatidylserine\u002Fprothrombin) in identifying APS in patients with thrombosis\u002Frecurrent adverse pregnancy outcomes.",[25,524],"Seronegative Antiphospholipid Syndrome","2025-05-09",{"date":527,"type":32},"2025-05-14",{"date":529,"type":32},"2024-09-21",{"date":531,"type":21},"2026-09",{"name":533,"class":39},"Italian Society for Rheumatology",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":180,"enrollmentInfo":541,"targetDuration":4,"studyType":79,"phases":542,"briefSummary":543,"conditions":544,"keywords":547,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":40},"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":340,"type":21},[481],"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.",[113,189,148,393,545,25,546,237,322],"IgG4-Related Diseases","Acquired Thrombotic Thrombocytopenic Purpura",[548,549,550],"CAR-T","CD19","BCMA","2025-04-01",{"date":553,"type":32},"2025-04-02",{"date":555,"type":32},"2024-12-26",{"date":492,"type":21},{"name":558,"class":39},"Peking University People's Hospital",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":79,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":172},"100454620","phase-2-safety-and-efficacy-of-zanubrutinib-in-the-treatment-of-antiphospholipid-syndrome-with-secondary-thrombocytopenia-100454620","NCT05199909","Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia","Prospective, Single Arm and Open Clinical Observation of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia","Inclusion Criteria:\n\n* Age 18 and above, male or female；\n* Diagnosis of antiphospholipid syndrome；\n* Failure to receive glucocorticoid treatment in the past (the curative effect cannot be maintained, or recurs, or cannot be tolerated); Can not choose other second-line treatment, such as rituximab, cyclosporine, cyclophosphamide, etc.; Or rituximab, cyclosporine and other treatments are ineffective, relapsed or intolerable;\n* Plt \\\u003C 30×10\\^9\u002FL；\n* Liver and kidney function, such as ALT, AST, BUN, SCR \\\u003C 1.5 × upper limit of normal value, passing physical examination;\n* ECOG physical state score ≤ 2 points；\n* Cardiac function of the New York Society of Cardiac Function ≤ 2；\n* Signed and dated written informed consent.\n\nExclusion Criteria:\n\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases；\n* HIV positive;\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;\n* Patients with thrombotic diseases such as new pulmonary embolism and unstable period of various arteriovenous thrombosis;\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;\n* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer，etc.);\n* Patients with septicemia or other irregular severe bleeding;\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.",{"count":127,"type":21},[481],"To evaluate the safety and efficacy of zanubrutinib in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in 10 patients.",[25,505,570],"Treatment","2025-02-20",{"date":573,"type":32},"2025-02-24",{"date":575,"type":32},"2022-01-25",{"date":577,"type":21},"2025-06-30",{"name":305,"class":39},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":40},"100578231","clinical-outcomes-of-primary-versus-secondary-antiphospholipid-syndrome-100578231","NCT06808607","Clinical Outcomes of Primary Versus Secondary Antiphospholipid Syndrome","Thrombotic Outcome of Primary Versus Secondary Antiphospholipid Syndrome","Inclusion Criteria:\n\n* All patients diagnosed as antiphospholipid syndrome in clinical hematology or rheumatology units in internal medicine department, Assiut university hospital.\n\nExclusion Criteria:\n\n* patients with other risk factor for thrombosis (malignancy, cocs, protein c or protein s deficiency etc","55 Years",{"count":588,"type":21},52,"Observational retrospective cohort study to assess clinical outcomes in patients with primary versus secondary antiphospholipid syndrome",[25],[54,117],"2025-01-29",{"date":447,"type":32},{"date":595,"type":21},"2025-02-07",{"date":597,"type":21},"2026-03-06",{"name":599,"class":39},"Assiut University",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":608,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":79,"phases":610,"briefSummary":611,"conditions":612,"keywords":618,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":627,"locationsCount":629},"100515753","phase-4-comparison-of-clopidogrel-based-antiplatelet-therapy-versus-warfarin-as-secondary-prevention-strategy-for-antiphospholipid-syndrome-related-stroke-100515753","NCT05995600","Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE","Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE)","APS-STROKE","Inclusion Criteria:\n\n* Age 19 years or older\n* History of ischemic stroke (cerebral infarction, transient ischemic attack, or retinal arterial ischemic event)\n* Patients who meet the laboratory diagnostic criteria for antiphospholipid syndrome (APS)\n* Patients or guardians who agree to the study protocol and sign with informed consent\n\nExclusion Criteria:\n\n* Patients with high-risk antiphospholipid antibody profile (triple positivity; persistent high-titers exceeding 80 U\u002FmL of anti-cardiolipin or anti-β2 glycoprotein I antibodies)\n* Systemic lupus erythematous\n* Patients unable to discontinue previously taken anticoagulants or antiplatelet agents (e.g., atrial fibrillation, valvular heart disease, or a history of percutaneous coronary intervention)\n* Women who are pregnant, breastfeeding, or intending to become pregnant during the study period\n* Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion","19 Years",{"count":389,"type":21},[141],"Antiphospholipid syndrome (APS) has a close association with ischemic stroke; however, the optimal treatment strategy for APS-related stroke has yet to be established. The clinical guidelines suggest using warfarin for APS-related stroke, but these suggestions are largely based on retrospective studies from the 1990s and expert opinion, rather than high-quality clinical trials. Moreover, the evidence on the role of antiplatelet drugs other than aspirin (e.g., clopidogrel) in APS-related stroke is particularly limited. Considering the relatively young age of patients with APS and the high clinical burden of using warfarin, it is necessary to verify whether warfarin is essential. Thus, the investigators aim to compare clopidogrel-based antiplatelet therapy and warfarin as a secondary preventive medication for patients with APS-related stroke. APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS who have a history of ischemic stroke will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematous, or indications for continued antiplatelet or anticoagulant therapy will be excluded. Eligible patients will be 1:1 randomized to receive clopidogrel-based antiplatelet therapy or warfarin. Patients assigned to the clopidogrel-based antiplatelet therapy group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion. The primary outcome is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.",[25,613,614,615,616,617],"Ischemic Stroke","Transient Ischemic Attack","Cerebrovascular Disease","Cardiovascular Diseases","Major Bleed",[117,619,620,54],"Ischemic stroke","Secondary prevention","2024-10-13",{"date":623,"type":32},"2024-10-16",{"date":625,"type":32},"2024-02-20",{"date":36,"type":21},{"name":628,"class":39},"Seoul National University Hospital",32,{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":180,"enrollmentInfo":637,"targetDuration":4,"studyType":79,"phases":639,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":40},"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":638,"type":21},6,[81],"An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent\u002Frefractory autoimmune disease",[113,211,189,190,25,188],"2024-08-27",{"date":644,"type":32},"2024-08-29",{"date":646,"type":32},"2024-04-24",{"date":648,"type":21},"2026-04-21",{"name":199,"class":200}]