[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-inflammatory-myopathies-iims\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-inflammatory-myopathies-iims":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,64,88,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100592260","phase-2-allonk-an-allogeneic-non-genetically-modified-cord-blood-derived-nk-cell-therapy-in-combination-with-rituximab-studied-in-relapsing-forms-of-b-cell-dependent-rheumatologic-diseases-100592260",false,"NCT06991114","AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.","An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK®, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases","For Subjects with Refractory Rheumatoid Arthritis (RA):\n\n* Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria.\n* Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.\n* High-sensitivity C-reactive protein (hs-CRP) \\> 3 mg\u002FL or Erythrocyte Sedimentation Rate (ESR) \\> 28 mm\u002Fhr.\n* Have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician.\n* Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment.\n\nFor subjects with Sjögren's Disease (SjD)\n\n* Prior diagnosis of Primary SjD as per 2016 ACR\u002FEULAR criteria with confirmatory diagnosis in the 24 weeks preceding screening.\n* Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) \\> 6.\n* Salivary Flow Rate \\> 0.1 mL\u002Fmin on stimulation.\n\nFor subjects with Idiopathic Inflammatory Myopathies (IIMs)\n\n* Presence of a positive autoantibody (ANA \\>1:80 or RNP or SSA\u002FSSB or other myositis specific autoantibodies.\n* Refractory IIM as defined by inadequate response\u002Fintolerance to at least 3 months of glucocorticoids and\u002For at least one other immunosuppressive.\n* Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12 months prior to enrollment.\n\nFor Subjects with Systemic Sclerosis (SSc)\n\n* Diagnosis of SSc in accordance with the ACR\u002FEULAR 2013 classification.\n* Modified Rodnan skin score (mRSS) \\> 10.\n* Initial confirmatory diagnosis within 8 years of screening.\n* Refractory SSc as defined by inadequate response\u002Fintolerance to at least 3 months of glucocorticoids and\u002For at least one other immunosuppressive.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.",[26,27,28,29,30,31,32,33,34],"Refractory Rheumatoid Arthritis (RA)","Idiopathic Inflammatory Myopathies (IIMs)","Systemic Sclerosis (SSc)","Rheumatoid Arthritis (RA","IIM","Myositis","Scleroderma","Sjogren Syndrome","Sjogrens Disease",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"Refractory Rheumatoid Arthritis","AlloNK","Idiopathic Inflammatory Myopathies","Systemic Sclerosis","Sjögren's Disease","Refractory RA","Cell Therapy","Allogeneic NK Cells","Allogeneic Cell Therapy","non-genetically modified","rituximab","cord blood cells","ADCC enhancement","outpatient","community","RECRUITING","2026-05-20",{"date":54,"type":55},"2026-05-22","ACTUAL",{"date":57,"type":55},"2025-07-09",{"date":59,"type":20},"2029-01",{"name":61,"class":62},"Artiva Biotherapeutics, Inc.","INDUSTRY",52,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100636329","clinical-characteristics-and-mechanism-research-of-deucravacitinib-in-the-idiopathic-inflammatory-myopathies-100636329","NCT07564271","Clinical Characteristics and Mechanism Research of Deucravacitinib in the Idiopathic Inflammatory Myopathies","Real-world Experience With Deucravacitinib for the Treatment of Idiopathic Inflammatory Myopathies -- a Prospective Observational Study","Inclusion Criteria:\n\n* Adults between 18 years and 75 years of age.\n\n  * Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan \\& Peter DM\u002FPM or American College of Rheumatology(ACR) \\& European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria.\n  * Active disease: MDAAT skin VAS ≥ 3 cm, with at least 3 core indicators abnormal;\n  * Inadequate response to or intolerance of conventional treatments (such as glucocorticoids, immunosuppressants).\n\nExclusion Criteria:\n\n* Any subject meeting either of the following criteria should be excluded:\n\n  * Combined with other systemic autoimmune diseases;\n  * Severe hepatic and renal dysfunction;\n  * Active infections (such as tuberculosis, hepatitis B, HIV);\n  * Pregnant or lactating women;\n  * Previous use of JAK inhibitors.","75 Years",{"count":73,"type":20},10,"OBSERVATIONAL","This study aims to explore the clinical characteristics and mechanism of Deucravacitinib in the treatment of idiopathic inflammatory myopathies.Detailed Description: The investigators designed a single center, open-label, prospective study. Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan \\& Peter Dermatomyositis\u002FPolymyositis(DM\u002FPM) or Rheumatology(ACR) \\& European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. Deucravacitinib 6 mg once a day was administered for 6 months to explore its efficacy and safety, which could help to evaluate Deucravacitinib clinical characteristics and mechanism. Patients would be evaluated the improvement of clinical and laboratory indexes. Changes of symptoms, immune cell subsets and cytokines were monitored. Symptoms were evaluated by Visual Analogue Scale (VAS) of patient global and physician global, manual muscle testing(MMT-8), the Health Assessment Questionnaire(HAQ), Creatine kinase, Myositis Disease Activity Assessment Tool(MDAAT).",[27],"2026-04-26",{"date":79,"type":55},"2026-05-04",{"date":81,"type":55},"2025-10-05",{"date":83,"type":20},"2026-10-01",{"name":85,"class":86},"Peking University People's Hospital","OTHER",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":16,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":115,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"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",true,"12 Years","59 Years",{"count":100,"type":20},477,[102],"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.",[105,106,107,108,28,27,109,110,111,112,113,114],"Rheumatoid Arthritis (RA)","Juvenile Idiopathic Arthritis (JIA)","Systemic Lupus Erythematosus (SLE)","Juvenile Systemic Lupus Erythematosus","Axial Spondyloarthritis","Psoriatic Arthritis (PsA)","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[116,117,118,119,120,121,122],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","2026-04-14",{"date":125,"type":55},"2026-04-15",{"date":127,"type":20},"2026-03-16",{"date":129,"type":20},"2028-12-30",{"name":131,"class":86},"University of Sao Paulo General Hospital",2,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":140,"maxAge":17,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":87},"100626699","phase-1-yts109-in-pediatric-relapsedrefractory-autoimmune-diseases-100626699","NCT07439029","YTS109 in Pediatric Relapsed\u002FRefractory Autoimmune Diseases","An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Children With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n\\-\n\n1. Age 5 to \\\u003C18 years at screening; sex not restricted.\n2. CD19 positivity: Presence of CD19-positive B cells in peripheral blood, confirmed by flow cytometry.\n3. Adequate major organ function, meeting all of the following criteria:\n\n1）Bone marrow function:\n\n1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL (no colony-stimulating factor use within 2 weeks prior to testing; neutropenia attributable to the underlying disease may be allowed);\n2. Hemoglobin ≥ 60 g\u002FL. 2）Hepatic function: ALT ≤ 3 × ULN (exceptions allowed for elevations attributable to the underlying disease); AST ≤ 3 × ULN (exceptions allowed for elevations attributable to the underlying disease); Total bilirubin (TBIL) ≤ 1.5 × ULN (exceptions allowed for elevations attributable to the underlying disease).\n\n   3）Renal function: Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m², calculated using the Schwartz formula (exceptions allowed for reduced renal function attributable to the underlying disease).\n\n   4）Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and prothrombin time (PT) ≤ 1.5 × ULN.\n\n   5）Cardiac status: Hemodynamically stable. 4. Females of childbearing potential must be not pregnant and not breastfeeding during screening and throughout the study period.\n\n   5\\. The participant and the legal guardian are willing to participate, provide written informed consent, and can comply with study procedures and follow-up.\n\n   Specific inclusion criteria:\n\n   Recurrent refractory systemic lupus erythematosus\n\n   1\\. Meets the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE).\n\n   2\\. Active disease, defined as either: SELENA-SLEDAI ≥ 6 and at least one BILAG-2004 organ domain score of A (severe activity) or two domains scored B (moderate activity), or a combination thereof; or SELENA-SLEDAI ≥ 8.\n\n   3\\. Relapsed\u002Frefractory or intolerant to conventional therapy, defined as one of the following: Inadequate response after \\>3 months of conventional therapy; or intolerance to treatment-related adverse effects; or Disease flare\u002Frecurrence after achieving remission based on the LLDAS criteria. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n   4\\. If renal involvement is present, a kidney biopsy must have been performed within 12 months prior to treatment, demonstrating active lesions or predominantly active lesions on pathology.\n\n   Relapsing refractory\u002Fprogressive diffuse systemic sclerosis\n   1. Meets the 2013 ACR classification criteria for systemic sclerosis and is consistent with the diffuse cutaneous subtype (dcSSc).\n   2. Positive for any antinuclear antibody (ANA) or systemic sclerosis-associated autoantibody.\n   3. Evidence of diffuse cutaneous skin sclerosis and\u002For active interstitial lung disease (ILD), defined as ground-glass opacities on high-resolution computed tomography (HRCT).\n   4. Inadequate response to conventional therapy for \\>3 months or disease relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, JAK inhibitors, or any biologic agent, including rituximab, tocilizumab, TNF-α inhibitors (etanercept, adalimumab, infliximab), and telitacicept.\n   5. Progressive disease, defined as either:\n\n   1） Rapid skin progression: mRSS increase \\>25%; or 2） Progressive lung disease: FVC decline ≥10%, or FVC decline ≥5% accompanied by DLCO decline ≥15%.\n\n   Note: Criterion 4 or 5 must be met (either one is sufficient).\n\n   Recurrent refractory\u002Fprogressive inflammatory myopathy:\n\n   1\\. Meets the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including dermatomyositis \\[DM\\], polymyositis \\[PM\\], antisynthetase syndrome \\[ASS\\], and necrotizing myopathy \\[NM\\]).\n\n   2\\. Positive for myositis-specific and\u002For myositis-associated autoantibodies. 3. Evidence of active disease meeting either of the following:\n\n   1\\) Muscle involvement: CMAS \\\u003C 30 and at least two abnormal findings among the following core measures: Physician Global Assessment (PhGA) ≥ 2, Patient\u002FParent Global Assessment (PtGA) ≥ 2, extra-muscular disease activity score ≥ 2, and\u002For serum muscle enzymes ≥ 1.5 × ULN; or 2) Interstitial lung disease (ILD): CMAS ≥ 30 but with active ILD, defined as ground-glass opacities on high-resolution computed tomography (HRCT).\n\n   4\\. Inadequate response to conventional therapy for \\>3 months, or intolerance to treatment-related adverse effects, or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, intravenous immunoglobulin (IVIG), azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, JAK inhibitors, or any biologic agent, including rituximab, tocilizumab, TNF-α inhibitors (etanercept, adalimumab, infliximab), and telitacicept.\n\n   5\\. Progressive disease, defined as worsening myositis or rapidly progressive interstitial lung disease (RP-ILD).\n\n   Note: Criterion 4 or 5 must be met (either one is sufficient). Recurrent refractory sjogren's syndrome\n   1. Meets the 2002 American-European Consensus Group (AECG) classification criteria for primary Sjögren's syndrome or the 2018 Japanese classification criteria.\n   2. Active disease, defined as ESSDAI ≥ 6.\n   3. Positive for anti-SSA\u002FRo antibodies.\n   4. Inadequate response to conventional therapy for \\>3 months or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n   Recurrent\u002Frefractory ANCA-associated vasculitis:\n   1. Meets the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis, including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), and eosinophilic granulomatosis with polyangiitis (EGPA).\n   2. Positive for ANCA, defined as MPO-ANCA and\u002For PR3-ANCA positivity.\n   3. Active vasculitis, defined as Paediatric Vasculitis Activity Score (PVAS) ≥ 15 (maximum score 65).\n   4. Inadequate response to conventional therapy for \\>3 months or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n      Recurrent refractory\u002Fcatastrophic antiphospholipid syndrome:\n\n   1\\. Meets the 2006 revised Sydney classification criteria for primary antiphospholipid syndrome (APS).\n\n   2\\. Positive for antiphospholipid antibodies (aPL) at medium to high titers, defined as lupus anticoagulant (LA), anti-β2-glycoprotein I (anti-β2GPI) IgG\u002FIgM, and\u002For anticardiolipin (aCL) IgG\u002FIgM, with ≥2 positive tests at least 12 weeks apart.\n\n   3\\. Relapsed\u002Frefractory APS, defined as recurrent thrombosis despite standard-of-care therapy, including:\n   1. Anticoagulation with warfarin or another vitamin K antagonist (VKA) with INR maintained within the target therapeutic range, or therapeutic-dose low-molecular-weight heparin (LMWH), and\n   2. Prior treatment with glucocorticoids and cyclophosphamide, with subsequent recurrent thrombosis.\n\n   4\\. Catastrophic antiphospholipid syndrome (CAPS), defined by fulfillment of all four criteria:1) Involvement of three or more organs, systems, and\u002For tissues; 2) Development of manifestations within one week; 3)Histopathologic confirmation of small-vessel thrombosis\u002Focclusion in at least one organ or tissue; 4) aPL positivity.\n\n   Note: Criterion 3 or 4 must be met (either one is sufficient).\n\n   Exclusion Criteria:\n   1. History of severe drug allergy or a known allergic predisposition.\n   2. Presence of, or suspected uncontrolled infection requiring treatment, including fungal, bacterial, viral, or other infections.\n   3. Central nervous system (CNS) disorders, except for prior seizures, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis attributable to the underlying disease, as determined by the investigator.\n   4. Cardiac dysfunction deemed unable to tolerate study treatment (i.e., inadequate cardiac function at the investigator's discretion).\n   5. Known congenital immunoglobulin deficiency.\n   6. Presence of severe congenital structural malformations or syndromic birth defects (e.g., severe cardiovascular malformations, severe CNS malformations), or a confirmed diagnosis of a severe inherited metabolic disorder that, in the investigator's judgment, may significantly increase trial-related risk or interfere with compliance and interpretation of results.\n   7. History of malignancy within the past 5 years.\n   8. End-stage renal disease.\n   9. Evidence of certain chronic\u002Factive infections, including: HBsAg-positive, or HBcAb-positive with peripheral blood HBV DNA above the upper limit of detection; Anti-HCV antibody positive with detectable HCV RNA; HIV antibody positive; Positive syphilis test.\n   10. Psychiatric illness or severe cognitive impairment.\n   11. Participation in another clinical trial within 3 months prior to enrollment.\n   12. Use of immunosuppressive agents with therapeutic effects on the underlying disease within five half-lives prior to enrollment, or use of biologic agents within 4 weeks prior to enrollment.\n   13. Pregnant or planning pregnancy (females).\n   14. Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.","5 Years",{"count":142,"type":20},12,[144],"PHASE1","This exploratory, single-arm, open-label study will evaluate the safety and preliminary efficacy of YTS109 cell therapy in pediatric patients with relapsed\u002Frefractory autoimmune diseases, including systemic lupus erythematosus, diffuse systemic sclerosis, idiopathic inflammatory myopathies, and Sjögren's syndrome, as well as other eligible autoimmune diseases defined by the protocol eligibility criteria. Approximately 12 patients aged 5 to \\\u003C18 years will be enrolled at Children's Hospital of Fudan University and will receive a single intravenous infusion of YTS109 cells. Dose escalation will follow a standard 3+3 design starting at 1.5 × 10\\^6 cells\u002Fkg. The primary objective is to assess the safety and preliminary efficacy of YTS109 cell therapy in this population. Secondary objectives include characterizing the pharmacokinetic and pharmacodynamic profiles of YTS109 cells. Primary endpoints include the type, severity, and frequency of adverse events, along with efficacy assessments.",[107,147,27,148,149,150],"Diffuse Systemic Sclerosis","ANCA Associated Vasculitis (AAV)","Antiphospholipid Syndrome (APS)","Sjogren's Syndrome (SS)","NOT_YET_RECRUITING","2026-02-23",{"date":154,"type":55},"2026-02-27",{"date":156,"type":20},"2026-03",{"date":158,"type":20},"2030-07",{"name":160,"class":86},"Children's Hospital of Fudan University"]