[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjogren39s-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjogren39s-syndrome":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,106,136,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":70,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100424417","unhide-project-a-digital-health-platform-to-collect-lifestyle-data-for-brain-inflammation-research-100424417",false,"NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform",true,"ALL","2 Years",{"count":20,"type":21},10000,"ESTIMATED","10 Years","OBSERVATIONAL","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69],"Post-Acute COVID-19 Syndrome","ME\u002FCFS","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Psoriatic Arthritis (PsA)","Ankylosing Spondylitis (AS)","Autoimmune Encephalitis","Celiac Disease","Celiac Disease in Children","Chronic Lyme Disease","Post-treatment Lyme Disease Syndrome","Crohn's Disease","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Fibromyalgia (FM)","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Multiple Sclerosis","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis, Generalized","Myasthenia Gravis in Children","Narcolepsy","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Inflammatory Bowel Disease (IBD)","Autoimmune Diseases","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[46,71,72,73,74,75,76,77,78,79,27,80,81,82,83,84,48,85,86,87,88,89,90,91,92],"Myalgic Encephalomyelitis","Chronic Fatigue Syndrome","Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Autoimmune encephalitis","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Celiac disease","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Fatigue","Post-exertional malaise","Brain Fog","Mental health","RECRUITING","2026-01-20",{"date":96,"type":97},"2026-01-22","ACTUAL",{"date":99,"type":97},"2023-07-05",{"date":101,"type":21},"2030-12-31",{"name":103,"class":104},"Brain Inflammation Collaborative","OTHER",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":105},"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.","18 Years","65 Years",{"count":116,"type":21},15,"INTERVENTIONAL",[119],"NA","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.",[122,123,124,68,125,126],"Systemic Sclerosis (SSc)","ANCA Associated Vasculitis (AAV)","Idiopathic Inflammatory Myopathy (IIM)","Antiphospholipid Syndrome","Systemic Lupus Erythematosus","2025-12-21",{"date":129,"type":97},"2025-12-29",{"date":131,"type":97},"2025-01-06",{"date":133,"type":21},"2027-01-06",{"name":135,"class":104},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":16,"sex":17,"minAge":113,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":145,"conditions":146,"keywords":155,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"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.",{"count":144,"type":21},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.",[147,68,148,122,149,150,151,152,153,30,154],"Systemic Lupus Erthematosus","Inflammatory Myopathies","Vasculitis","Rheumatoid Arthritis (RA)","Ankylosing Spondylitis","Osteoarthritis","Gouty Arthritis (GA)","Healthy Controls",[156,157],"autoimmune diseases","mass spectrometry","NOT_YET_RECRUITING","2025-09-16",{"date":161,"type":97},"2025-09-23",{"date":159,"type":21},{"date":164,"type":21},"2026-09-30",{"name":166,"class":104},"Peking University People's Hospital",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":113,"maxAge":114,"enrollmentInfo":174,"targetDuration":4,"studyType":117,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":105},"100591301","phase-1-a-clinical-study-of-yts109-cell-in-rr-autoimmune-diseases-100591301","NCT06978647","A Clinical Study of YTS109 Cell in R\u002FR Autoimmune Diseases","An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed\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. Detection of positive CD19 expression on peripheral blood B cells by flow cytometry.\n3. Essential Organ Function Criteria:\n\n\u003C!-- -->\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use).\n\n   Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL ≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n5\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1\\. Meeting the EULAR\u002FACR 2019 SLE Classification Criteria; 2. SELENA SLEDAI≥6, or the presence of significant organ involvement, such as lupus nephritis (LN), etc; 3. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing treatment with a regimen containing at least two immunosuppressive agents (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolate mofetil (MMF), and cyclosporine) and\u002For biological agents for a minimum duration of two months.\n\nRelapsing and refractory Sjögren's syndrome:\n\n1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n3. Testing positive for anti-SSA\u002FRo antibodies;\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Sjogren's Syndrome:\n\n1. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;\n2. Testing positive for systemic sclerosis-related antibodies;\n3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Inflammatory Myopathy:\n\n1. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM);\n2. Testing positive for myositis-specific antibodies;\n3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n1. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n3. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n4. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Antiphospholipid Syndrome:\n\n1\\. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nRelapsing and refractory Rheumatoid arthritis:\n\n1\\. Diagnosed with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria, with a history of RA ≥ 3 months; 2. Inadequate response to at least two conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and at least one biological agent targeting cytokines\u002Fsignal transduction pathways (such as TNFα inhibitors, IL-6R antagonists, anti-CD20 monoclonal antibodies, etc.). (Note: Inadequate response to methotrexate or leflunomide, with stable treatment for ≥ 3 months prior to screening); 3. Moderate to severe active RA: swollen joint count (SJC) ≥ 6, tender joint count (TJC) ≥ 6; 4. Elevation of at least one inflammatory marker: erythrocyte sedimentation rate (ESR) ≥ 28 mm\u002Fh or C-reactive protein (CRP) ≥ upper limit of normal (ULN).\n\nRelapsing and refractory IgG4-Related Disease:\n\n1. Meeting the 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) diagnostic criteria for IgG4-related disease (IgG4-RD);\n2. Having an IgG4-RD responder index (RI) ≥ 2 during the screening period, indicating active disease;\n3. Meeting the criteria for refractory or relapsing IgG4-RD:\n\n1\\) Refractory: Defined as a lack of response to steroid therapy or steroid plus immunosuppressive therapy (no clinical or radiological improvement, with a decrease in RI \\\u003C 2); 2) Relapse: Defined as new progression or recurrence of clinical symptoms or radiological manifestations in patients who have previously achieved remission, with or without an elevation in serum IgG4 levels (an increase in RI ≥ 2).\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n  1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n  2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n  3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n  4. Subjects whose cardiac function cannot tolerate the study interventions;\n  5. Subjects with congenital immunoglobulin deficiencies;\n  6. Subjects with a history of malignant tumors within the past five years;\n  7. Subjects with end-stage renal failure;\n  8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n  9. Subjects with psychiatric disorders or severe cognitive dysfunction;\n  10. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n  11. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n  12. Pregnant women or women planning to become pregnant;\n  13. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":175,"type":21},12,[177],"PHASE1","This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells\u002Fkg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.",[180,122,181,182,183,150,184,68],"Systemic Lupus Erythematosus (SLE)","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Antiphospholipid Syndrome (APS)","IgG4-Related Diseases","2025-07-10",{"date":187,"type":97},"2025-07-14",{"date":189,"type":97},"2025-05-19",{"date":191,"type":21},"2027-05-19",{"name":193,"class":194},"China Immunotech (Beijing) Biotechnology Co., Ltd.","INDUSTRY"]