[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-myopathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-myopathies":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,79,112,138,156],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100614028","inspiratory-muscle-training-in-patients-with-inflammatory-myopathy-100614028",false,"NCT07274267","Inspiratory Muscle Training in Patients With Inflammatory Myopathy","The Effect of Inspiratory Muscle Training on the Functional Status of Patients With Inflammatory Myopathy","Inclusion Criteria:\n\n* Diagnosis of inflammatory myopathy according to European Alliance of Associations for Rheumatology \u002F American College of Rheumatology criteria\n* Age ≥ 18 years\n* Stable clinical condition allowing participation in physical activity\n* Ability to understand and follow instructions\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Cognitive impairment preventing proper exercise performance\n* Current respiratory tract infection\n* Previous respiratory muscle training within the last 12 months\n* History of spontaneous pneumothorax\n* Pulmonary hypertension\n* Tympanic membrane rupture or other middle ear pathology\n* Lack of voluntary and informed consent","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23],"NA","Inflammatory myopathies are rare autoimmune diseases leading to progressive muscle weakness, often including the respiratory muscles. This study aims to investigate whether inspiratory muscle training (IMT) using a threshold device can improve functional status in patients with inflammatory myopathy. Thirty-three patients will undergo a 3-month home-based IMT program with progressive resistance. Functional capacity, inspiratory muscle strength, lung function, diaphragmatic mobility, fatigue, and quality of life will be assessed at baseline and during follow-up. The primary hypothesis is that IMT will enhance inspiratory muscle strength and translate into better functional performance and quality of life.",[26],"Inflammatory Myopathies",[28,29,30,31],"Inspiratory muscle training","Diaphragm ultrasound","Respiratory muscle strength","Exercise tolerance","RECRUITING","2026-02-23",{"date":35,"type":36},"2026-02-25","ACTUAL",{"date":38,"type":36},"2024-08-12",{"date":40,"type":20},"2026-12",{"name":42,"class":43},"Józef Piłsudski University of Physical Education","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":44},"100612090","interferon-signature-in-anti-ctla-4-and-anti-pd-1pd-l1-treated-cancer-patients-compared-with-systemic-autoimmune-disease-patients-100612090","NCT07249060","Interferon Signature in Anti-CTLA-4 and Anti-PD-1\u002FPD-L1-Treated Cancer Patients Compared With Systemic Autoimmune Disease Patients","Interferon Signature in Cancer Patients Treated With Anti-CTLA-4 and Anti-PD-1\u002FPD-L1 Therapies: A Multicenter, Prospective, Observational Cohort Study Comparing Cancer Patients and Non-Cancer Patients With Systemic Autoimmune Diseases","INTER-AUTENTIC","ICI cohort:\n\nInclusion Criteria:\n\n* Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines;\n* Patients who are treatment-naïve to ICIs; and\n* Age ≥18 years.\n\nExclusion Criteria:\n\n* Estimated mortality of less than 3 months from the start of treatment;\n* Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments;\n* Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group \\[ECOG\\] ≥3);\n* Ongoing immunosuppressive therapy, including prednisone at doses \\>10 mg\u002Fday or equivalent.\n\nSAD cohort:\n\nInclusion Criteria:\n\n* Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR\u002FEULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR\u002FEULAR 2016), Systemic Sclerosis (SSc) (ACR\u002FEULAR 2013), and\u002For Idiopathic Inflammatory Myopathy (IIM) (ACR\u002FEULAR 2017).\n* Age ≥18 years old.\n\nExclusion Criteria:\n\n* Estimated mortality less than 3 months from the start of follow-up.\n* Active immunosuppressive treatment, including prednisone at doses \\>10 mg\u002Fday or equivalent.\n* Recent diagnosis (\\\u003C1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.",{"count":54,"type":20},300,"48 Weeks","OBSERVATIONAL","This study aims to identify a way to predict the side effects that some people with cancer experience when receiving immunotherapy. These side effects, known as immune-related adverse events (irAEs), occur when the immune system mistakenly attacks healthy tissues, like certain autoimmune diseases. At present, clinicians lack reliable tests to determine who is most likely to develop these reactions. The goal of this study is to determine whether substances in the blood called interferons (IFNs) could serve as early warning markers.\n\nThe study will include 300 people with cancer who are about to begin immunotherapy. To provide a meaningful comparison, the investigators will also enroll 40 individuals with autoimmune diseases such as lupus. Understanding how IFN levels differ between these groups may help clarify whether IFN patterns in cancer patients resemble those seen in autoimmune disease.\n\nParticipants in both groups will be asked to provide small blood samples at predefined time points during their clinical care or treatment. Researchers will measure the levels of different IFN types in all samples to compare IFN levels between cancer patients and individuals with autoimmune diseases, and within the cancer group between patients who develop irAEs and those who do not. The long-term aim of the study is to develop a simple test that can help clinicians identify patients at higher risk of irAEs.\n\nImmune-related adverse events (irAEs) are a frequent complication in cancer patients treated with immune checkpoint inhibitors (ICIs), and they often resemble or exacerbate preexisting autoimmune diseases. Despite extensive research in the field, no validated predictive biomarkers of irAEs currently exist. Emerging evidence suggests that the IFN signature -long implicated in the pathogenesis of several systemic autoimmune diseases (SADs)- may also be upregulated in patients who develop ICI-induced irAEs, likely with substantial overlap among different IFN subtypes. Given these clinical and molecular similarities with SADs, it is plausible that IFN levels in peripheral blood carry predictive value for irAE risk, although the dominant IFN types in ICI-related toxicity remain unknown.\n\nThe INTER-AUTENTIC project aims to determine whether baseline IFN levels and their dynamic changes, measured in peripheral blood using a dedicated panel, can predict the onset of irAEs in cancer patients receiving ICIs. Supported by the Medical Oncology departments of six university hospitals in Northern Spain, this multicenter, observational, prospective cohort study has been underway since 2021. Biobank samples have been collected from ICI-treated patients before treatment initiation, at protocol-defined time points, and at the moment of irAE diagnosis (ICI cohort). The study seeks to identify the IFN subtypes with the most pronounced differential expression between patients with and without irAEs, and to evaluate whether IFN levels enhance the predictive performance of a model incorporating other clinical variables potentially associated with immune-mediated toxicity. A sample size of 300 cancer patients has been estimated for this analysis.\n\nIn addition, a second prospective cohort of 40 non-cancer patients with systemic lupus erythematosus, primary Sjögren's syndrome, systemic sclerosis, and\u002For idiopathic inflammatory myopathy (SAD cohort) will be included. Since IFNs play a well-established pathogenic role in these conditions, this cohort will allow characterization of the IFN signature at key follow-up points (baseline, remission, and disease flare) and comparison with the IFN profiles of ICI-treated patients, regardless of whether they develop irAEs.",[59,60,61,62,26,63],"Immune-Related Adverse Events","Lupus Erythematosus, Systemic","Sjogren Syndrome","Systemic Sclerosis (SSc)","Solid Tumors",[65,66,67,68,69,70],"Immune Checkpoint Inhibitors","Adverse events","Biomarkers","Predictive","Prospective Studies","Immune System","2025-11-25",{"date":73,"type":36},"2025-12-03",{"date":75,"type":36},"2024-01-08",{"date":40,"type":20},{"name":78,"class":43},"Hospital Universitario Araba",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":89,"conditions":90,"keywords":100,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100607417","mass-spectrometry-based-immune-profiling-in-autoimmune-diseases-100607417","NCT07188285","Mass Spectrometry-based Immune Profiling in Autoimmune Diseases","Mass Spectrometry-based Immune Profiling in Peripheral Blood of Autoimmune Diseases","Inclusion Criteria:\n\n1. Male or female, and aged 18-70 at the time of screening interview (inclusive).\n2. The diagnosis of each disease meets the following standards - Systemic lupus erythematosus: 1997 ACR lupus classification standard\n\n   * Behcet's disease: 2014 ICBD Behcet's disease classification standard\n   * ANCA-associated vasculitis: 1990 American College of Rheumatology Classification Standard\n   * Rheumatoid arthritis: 1987 ARA classification standard\n   * Ankylosing spondylitis: new york standard revised in 1984\n   * Sjogren's syndrome: 2016 ACR\u002FEULAR Sjogren's syndrome classification standard\n   * Inflammatory myopathy: Bohan recommended criteria in 1977\n   * Systemic sclerosis: SSc standard formulated by American Rheumatology Association in 1980.\n   * Psoriatic arthritis: CASPAR standard in 2006\n   * Gouty arthritis: 1997 ACR gout classification standard\n3. Disease activity status, each disease should meet the disease activity index;\n4. Glucocorticoid (≤1mg\u002Fkg\u002Fd prednisone or other hormones with equivalent dose) was used before joining the group, and DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) were allowed;\n5. When participating in the trial, the patient must be informed in writing and hope that the patient can abide by the requirements of the research follow-up plan and other protocols.\n\n   Exclusion Criteria:\n\n1\\. Use IVIg or cyclophosphamide within 1.2 months, use other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) within 3 months, and use rituximab within 6 months; 2.1 months after receiving high-dose glucocorticoid (\\> 1 mg\u002Fkg\u002Fd). 3. Serious complications: including heart failure (≥ NYHA III), renal insufficiency (creatinine clearance rate ≤30 ml\u002Fmin) and hepatic insufficiency (serum ALT or AST is greater than three times the normal upper limit, or total bilirubin is greater than the normal upper limit).\n\n4\\. Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve or brain diseases (including demyelinating diseases, such as multiple sclerosis).\n\n5\\. Suffering from serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or being hospitalized due to infection, or using intravenous antibiotics to treat infection 2 months before the first dose of treatment.\n\n6\\. Chest imaging showed abnormalities of malignant tumor or current active infection (including tuberculosis) within 3 months before enrollment.\n\n7\\. Infected with HIV(HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If the serum is positive, it is recommended to consult a doctor with expertise in treating HIV or hepatitis C virus infection.\n\n8\\. Any known malignant tumor or history of malignant tumor in the past 5 years. 9. Received any vaccination within 3 months before joining the group.",true,{"count":88,"type":20},500,"Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an early screening and diagnosis model of autoimmune diseases.",[91,92,26,62,93,94,95,96,97,98,99],"Systemic Lupus Erthematosus","Sjogren's Syndrome","Vasculitis","Rheumatoid Arthritis (RA)","Ankylosing Spondylitis","Osteoarthritis","Gouty Arthritis (GA)","Psoriatic Arthritis (PsA)","Healthy Controls",[101,102],"autoimmune diseases","mass spectrometry","NOT_YET_RECRUITING","2025-09-16",{"date":106,"type":36},"2025-09-23",{"date":104,"type":20},{"date":109,"type":20},"2026-09-30",{"name":111,"class":43},"Peking University People's Hospital",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":44},"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.","80 Years",{"count":121,"type":20},9,[123,124],"PHASE1","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.",[91,62,61,127,26,128],"ANCA Associated Vasculitis (AAV)","Antiphospholipid Syndrome","2025-08-14",{"date":131,"type":36},"2025-08-20",{"date":133,"type":36},"2025-07-01",{"date":135,"type":20},"2027-12-31",{"name":137,"class":43},"Peking University Third Hospital",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100579235","phase-1-safety-and-efficacy-of-universal-car-t-cells-uwd-cd19-combined-with-immunosuppressants-in-the-treatment-of-refractory-autoimmune-diseases-100579235","NCT06821659","Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age between 18-80 years (inclusive), male or female.\n2. \\>40kg.\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\nSystemic Lupus Erythematosus (SLE):\n\n1. Meets the 2019 EULAR\u002FACR classification criteria for SLE.\n2. ANA titer ≥1:80, or positive for anti-dsDNA and\u002For anti-Sm antibodies.\n3. Disease activity score (SLEDAI-2000) ≥8.\n\nSjögren's Syndrome:\n\n1. Meets the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome.\n2. Disease activity score (ESSDAI) ≥5.\n3. Positive for anti-SSA\u002FRo antibodies.\n\nSystemic Sclerosis (SSc):\n\n1. Meets the 2013 EULAR\u002FACR classification criteria for systemic sclerosis.\n2. Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.\n3. 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.\n\nIdiopathic Inflammatory Myopathies (IIM):\n\n1. Meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).\n2. 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).\n3. Positive for myositis-specific antibodies.\n\nANCA-Associated Vasculitis (AAV):\n\n1. Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.\n2. Positive for ANCA antibodies (current or historical).\n3. Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.\n\nExclusion Criteria:\n\n1. Subjects with a history of alcohol abuse or substance abuse within the past 24 weeks;\n2. Subjects with other psychiatric disorders such as schizophrenia or major depressive disorder;\n3. Subjects with a history of malignancies other than B-cell lymphoma;\n4. Subjects with overlapping diseases that affect the assessment of disease activity;\n5. Subjects with infections such as human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency virus infection, or chronic hepatitis B or C;\n6. Subjects with known active tuberculosis (TB) infection or bacterial infections;\n7. Subjects with a history of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, active arrhythmia, or other clinically significant heart diseases within 6 months prior to screening;\n8. Subjects with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n9. Subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels ≥3×ULN, or bilirubin \\>1.5×ULN, excluding abnormalities caused by theautoimmune disease;\n10. Subjects with chronic kidney failure stage 4 or above, defined as an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² or serum creatinine \\>2.5 mg\u002FdL;\n11. At the screening visit, subjects with any of the following significant hematologic abnormalities caused by bone marrow suppression, excluding abnormalities due to the autoimmune disease:\n\n    1. Hemoglobin \\\u003C70 g\u002FL;\n    2. Absolute neutrophil count \\\u003C500\u002Fmm³;\n    3. Platelet count \\\u003C50,000\u002Fmm³;\n12. Subjects with a history of severe adverse reactions to cyclophosphamide or fludarabine;\n13. Subjects with a prior history of CAR-T therapy;\n14. Subjects who received live vaccines within 30 days prior to CAR-T cell infusion;\n15. Subjects deemed unsuitable for participation in the study by the investigator.",{"count":121,"type":20},[123,124],"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, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis. 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. Clinical studies are exploring the use of CD19-targeting CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, we investigate the safety and efficacy of universal CD19-targeting CAR T cells in the treatment of autoimmune diseases.",[91,62,26,127,61],"2025-02-10",{"date":150,"type":36},"2025-02-12",{"date":152,"type":20},"2025-03-01",{"date":154,"type":20},"2028-12-31",{"name":137,"class":43},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":44},"100432945","search-for-diagnostic-and-prognostic-biomarkers-in-systemic-sclerosis-and-inflammatory-myopathies-100432945","NCT04917705","Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies","Search for Diagnostic and Prognostic Biomarkers (Molecular Signatures) in Systemic Sclerosis and Inflammatory Myopathies by a Multi-OMIC Strategy Integrating a Single Cell Analysis Approach","SCLEROMYOMICS","Inclusion Criteria:\n\n* Control population without inflammatory myopathy (population 1), suspected myopathy for whom a blood test and muscle biopsy are required to confirm the diagnosis\n* Confirmed inflammatory myopathy (population 2)\n* Control population without systemic sclerosis (population 3), with primary Raynaud's phenomenon\n* Early diffuse systemic cutaneous scleroderma (population 4)\n* Male or female (age ≥ 18, no upper age limit)\n\nExclusion Criteria:\n\nPopulations 1 \\& 2\n\n* Contraindication to muscle biopsy\n* Diagnosed for another neuromuscular disease\n* Taking an immunosuppressant \u002F immunomodulator treatment within 3 months before inclusion\n* Unbalanced cardiovascular pathology\n\nPopulation 3 \\& 4\n\n* Contraindication to skin biopsy\n* Capillaroscopic and \u002F or immunological anomaly suggesting scleroderma\n* Suspicion of scleroderma but diagnosed for another connectivitis\n* Immunosuppressive treatment (corticosteroids\\> 15 mg, methotrexate, mycophenolate mofetil) introduced for more than 1 month\n* Active or recent cancer \\\u003C3 years (apart from non-melanoma skin cancer).\n\nFor all\n\n\\- Pregnancy or breast feeding",{"count":165,"type":20},55,[23],"Systemic sclerosis and inflammatory myopathies, which sometimes combine (scleromyositis), have shared pathophysiological elements. In both diseases, many cell subtypes are involved in damage to organs such as T lymphocytes, B lymphocytes, and unconventional (non-B, non-T) lymphocytes called innate lymphoid cell (ILC). The increasing complexity of our understanding of the immune system (multiplication of recognized cell subtypes) also makes the strategies for analyzing pathophysiological mechanisms more complex. Currently, no biomarker perfectly predicts the phenotype and evolution of patients. Multi-OMIC analyzes will be performed (identification of cell populations as well as genomic, transcriptomic and proteomic characterization) in blood and tissue samples (skin and muscle biopsy) in patients with systemic sclerosis and inflammatory myopathies, with the objective of identifying discriminating molecular signatures (biomarkers) according to the characteristics of the disease and its evolution.",[169,26],"Systemic Sclerosis",[171,172,173,67,174],"Scleroderma","Myopathy","Multi-OMICS","Single-cell","2021-12-14",{"date":177,"type":36},"2021-12-15",{"date":179,"type":36},"2021-11-25",{"date":181,"type":20},"2028-06",{"name":183,"class":43},"University Hospital, Strasbourg, France"]