[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antisynthetase-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antisynthetase-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100624230","a-study-on-the-efficacy-and-safety-of-jak-inhibitors-versus-calcineurin-inhibitors-as-initial-therapy-for-interstitial-lung-disease-associated-with-antisynthetase-syndrome-100624230",false,"NCT07406932","A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome","JAKCNIASSILD","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Meet the 2017 EULAR\u002FACR diagnostic criteria for Anti-synthetase Syndrome (ASS).\n* Presence of Interstitial Lung Disease (ILD) confirmed by High-Resolution Computed Tomography (HRCT).\n* Active disease requiring initiation or intensification of immunosuppressive therapy, with no prior use of glucocorticoids, immunosuppressants, or biologics.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Diagnosis of Rapidly Progressive ILD (RP-ILD), defined as worsening dyspnea within 1 month and PaO2\u002FFiO2 ratio \\\u003C 250 mmHg.\n* Active uncontrolled severe infection, malignancy, or major organ failure.\n* Pregnancy or lactation.\n* Contraindications to the study drugs.\n* Concurrent use of other immunosuppressants or biologics.","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a prospective investigation comparing the efficacy and safety of Janus kinase inhibitors versus calcineurin inhibitors as initial therapy for interstitial lung disease associated with antisynthetase syndrome. The goal is to determine which treatment is more effective at improving lung function and preventing disease progression, while comparing their safety profiles. The findings will help provide clearer treatment guidance for doctors and patients.",[27,28],"Antisynthetase Syndrome","Interstitial Lung Disease (ILD)","RECRUITING","2026-05-31",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":21},"2026-05-18",{"date":37,"type":21},"2027-07-01",{"name":39,"class":40},"China-Japan Friendship Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100623051","phase-2-descartes-08-in-autoantibody-myositis-100623051","NCT07391605","Descartes-08 in Autoantibody Myositis","A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome","Inclusion Criteria:\n\n* Confirmed diagnosis of one of the following:\n\nDermatomyositis (DM): Probability score ≥55% on the 2017 EULAR\u002FACR (European Alliance of Associations of Rheumatology\u002F American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR\u002FEULAR Classification Criteria (1).\"\n\n* Participants must have dermatomyositis or antisynthetase syndrome with muscle and\u002For skin involvement.\n* Refractory or intolerance to standard therapy.\n* Stable background immunosuppressive therapy for ≥8 weeks.\n* Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air).\n* Informed consent, compliance with visits, contraception, and vaccinations required.\n\nExclusion Criteria:\n\n* Isolated interstitial lung disease (ILD) without muscle or skin involvement\n\n  * Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound).\n  * Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension.\n  * Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's).\n  * Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression.\n  * Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation.\n  * Pregnancy or lactation.\n  * Recent use of prohibited immunosuppressants\u002Fbiologics or investigational agents (per washout periods).\n  * Live vaccination within 4 weeks.\n  * History of primary immunodeficiency, organ or bone marrow transplant.\n  * Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent\u002Fsevere infections.",{"count":50,"type":21},60,[52],"PHASE2","This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).",[27],[56,57,58,59,60],"MYOSITIS","DESCARTES-08","MRNA CAR-T","TOTAL IMPROVEMENT SCORES","CDASI","2026-04-22",{"date":63,"type":33},"2026-04-23",{"date":65,"type":21},"2026-04-28",{"date":67,"type":21},"2028-05",{"name":69,"class":70},"Cartesian Therapeutics","INDUSTRY",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":41},"100563232","early-phase-1-an-exploratory-clinical-study-of-cd19-car-nk-cells-for-the-treatment-of-refractory-antisynthetase-antibody-syndrome-and-rheumatoid-arthritis-100563232","NCT06613490","An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis","An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis","Inclusion Criteria:\n\n1. Subjects voluntarily sign the Informed Consent Form (ICF) , participate in this clinical study and be willing to follow and be able to complete all trial procedures.\n2. Defined according to the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria, adult patients with RA diagnosed ≥3 months prior to screening;Moderately to severely active RA;Poor response, or loss of response, or intolerance to at least one conventional synthetic DMARD (csDMARD) or biologic DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).\n3. Defined according to the 2020 ENMC-DM classification diagnostic criteria. Adult patients with ASyS diagnosed ≥3 months prior to screening; patients with moderately severe active ASyS.\n4. Age: ≥ 18 years old and ≤ 70 years old, male or female.\n5. Subjects with estimated survival \\> 12 weeks.\n6. Serum creatinine clearance meets the relevant age\u002Fsex criteria, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN).\n7. ECOG score 0 - 2.\n8. The heart structure is essentially normal by echocardiography and Left ventricular ejection fraction (LVEF) ≥45%.\n9. 2 weeks after the subject received the last dose treatment (hormonal, immunosuppressive or other experimental treatment).\n\nExclusion Criteria:\n\n1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions.\n2. Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes.\n3. Subjects with Active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections.\n4. Subjects with grade III or IV heart failure (NYHA classification).\n5. History of epilepsy or other central nervous system (CNS) diseases.\n6. Subjects with history of malignancy except cured of carcinoma in situ of the skin or cervix, and patients with inactive tumors.\n7. Subjects with pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism.\n8. The subject with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months.\n9. Females who are pregnant, lactating, or planning a pregnancy within six months.\n10. Subjects who have received other clinical trial treatment within 3 months.","70 Years",{"count":81,"type":21},24,[83],"EARLY_PHASE1","A single-center, open-label dose-escalation design to evaluate the safety and efficacy of 3 infusions of anti CD19 CAR NK cells (KN5501), as well as the expansion and persistence of KN5501 in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA); To evaluate the ability of KN5501 to clear CD19-positive B cells in patients to determine the feasibility of KN5501 for the treatment of refractory ASyS and or RA.",[27,86],"Rheumatoid Arthritis","2025-04-26",{"date":89,"type":33},"2025-04-30",{"date":91,"type":21},"2025-05-20",{"date":93,"type":21},"2026-10-20",{"name":95,"class":40},"The First Affiliated Hospital with Nanjing Medical University",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100514891","evaluation-of-antigen-specific-t-cells-in-patients-with-antisynthetase-syndrome-and-interstitial-lung-disease-100514891","NCT05984394","Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease","Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease","CYTILDASS","Inclusion Criteria:\n\n* Patient with new diagnosis of AS with ILD\n\nExclusion Criteria:\n\n* Patient with ILD differential diagnosis\n* Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis",{"count":81,"type":21},"OBSERVATIONAL","Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1 and Th17 cells may represent a promising treatment in patients AS patients with ILD.\n\nInvestigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis are associated with ILD severity at diagnosis and could predict treatment response at 6 months.\n\nThe main objective is to study the correlation between BAL antigen-specific Th1 and Th17 cells at ILD diagnosis and clinical evolution after 6 months of treatment according to initial ILD severity.",[27],"2024-08-26",{"date":110,"type":33},"2024-08-27",{"date":108,"type":33},{"date":113,"type":21},"2025-10-31",{"name":115,"class":40},"Central Hospital, Nancy, France",6]