[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-inflammatory-myopathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-inflammatory-myopathies":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,47,78,112,133,172,210,238,265,289,310,340,362,382,406,427,467,489,516,543,572,592],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100633412","early-phase-1-mts109-in-patients-with-refractory-autoimmune-diseases-100633412",false,"NCT07526350","MTS109 in Patients With Refractory Autoimmune Diseases","A Study on the Safety, Tolerability and Efficacy of MTS109 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases, an Investigator-Initiated Trial","Inclusion Criteria:\n\n1\\) The subject or his\u002Fher legal representative has voluntarily signed a written informed consent form and is willing and able to comply with study procedures. 2) Aged 18 to 65 years (inclusive) at the time of signing the informed consent form, with no gender restriction.\n\n3\\) Subjects with SLE must meet the following criteria: a) Meet the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE); b) SLEDAI-2K score ≥6, with at least 1 BILAG-2004 organ domain score of Grade A (severe manifestation) or 2 Grade B (moderate manifestation), or both; or SLEDAI-2000 score ≥8; c) Meet the definition of refractory and relapsing disease: inadequate response to conventional therapy for more than 6 months, or disease flare after remission. Conventional therapy is defined as: glucocorticoids plus at least 2 of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and telitacicept.\n\n4\\) Subjects with idiopathic inflammatory myopathy (IIM) must meet the following criteria: a) Meet the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including dermatomyositis \\[DM\\], polymyositis \\[PM\\], anti-synthetase syndrome \\[ASS\\], and necrotizing myopathy \\[NM\\]); b) Positive for myositis-specific antibodies; c) Moderate-to-severe IIM during screening, defined as: MMT-8 ≥142 with active interstitial lung disease (ILD) (ground-glass opacity on HRCT); OR MMT-8 \\\u003C142 and at least 2 of the following: Physician's Global Assessment (PGA, VAS) ≥2 cm (10-cm VAS scale); Patient's Global Assessment (PtGA, VAS) ≥2 cm (10-cm VAS scale); Health Assessment Questionnaire Disability Index (HAQ-DI) \\>0.25; One or more muscle enzymes (CK, LDH, AST, ALT) ≥1.5 × upper limit of normal (ULN); d) Meet the definition of refractory, relapsing, or progressive disease: Refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE; Progressive: worsening myositis or rapidly progressive interstitial lung disease.\n\n5\\) Subjects with systemic sclerosis (SSc) must meet the following criteria: a) Meet the 2013 ACR classification criteria for systemic sclerosis; b) Positive for SSc-related specific antibodies; c) Meet the definition of refractory or progressive disease: Refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE; Progressive: rapid skin progression (increase in mRSS \\>25%); or progressive lung disease (decrease in FVC ≥10%, or decrease in FVC \\>5% with decrease in DLCO ≥15%).\n\n6\\) Subjects with ANCA-associated vasculitis (AAV) must meet the following criteria: a) Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; b) Positive for ANCA-associated antibodies (MPO-ANCA or PR3-ANCA); c) Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63), indicating active vasculitis; d) Meet the definition of refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE.\n\n7\\) Subjects with Sjögren's syndrome (SS) must meet the following criteria: a) Meet the 2002 AECG criteria for primary Sjögren's syndrome or the 2016 ACR\u002FEULAR classification criteria; b) Disease activity ESSDAI ≥6; c) Positive for anti-SSA\u002FRo antibody; d) Meet the definition of refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE.\n\n8\\) Screening laboratory results meet the following criteria (excluding abnormalities related to the study disease): a) Neutrophil count ≥1.5 ×10⁹\u002FL; b) Hemoglobin ≥80 g\u002FL; platelet count ≥50 ×10⁹\u002FL; c) Alanine aminotransferase (ALT) ≤3 × ULN; aspartate aminotransferase (AST) ≤3 × ULN (unless elevation is judged by the investigator to be related to PM or DM); total bilirubin (TBIL) \\\u003C2 × ULN (for subjects with Gilbert syndrome, direct bilirubin \\[DBIL\\] ≤1.5 × ULN); d) Creatinine clearance ≥30 mL\u002Fmin; e) Activated partial thromboplastin time (APTT) ≤1.5 × ULN; prothrombin time (PT) ≤1.5 × ULN; f) Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%, with no clinically significant electrocardiogram (ECG) abnormalities; g) Baseline oxygen saturation \\>92% while breathing room air.\n\n9\\) Female subjects of childbearing potential: negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening.\n\n10\\) Male subjects with female partners and female subjects of childbearing potential agree to use effective contraceptive methods (e.g., oral contraceptives, intrauterine device, condom) from screening until at least 1 year after the last dose of MTS109.\n\nExclusion Criteria:\n\n1. SLE subjects: a) Drug-induced SLE; b) Subjects with lupus crisis, or who require medications prohibited by the protocol due to comorbidities, or who are considered ineligible by the investigator.\n2. IIM subjects: a) Subjects with documented inclusion body myositis (IBM), drug-induced PM or DM, malignancy-associated PM or DM, or non-inflammatory myopathy (e.g., muscular dystrophy); b) Uncontrolled extramuscular involvement related to PM or DM: ILD: FVC \\\u003C55% or requiring oxygen therapy (FVC ≥55% to be evaluated for eligibility by the lead investigator); Severe dysphagia that, in the investigator's judgment, would increase subject risk by participating in the clinical trial; Severe cardiac manifestations (e.g., congestive heart failure, arrhythmia, treatable conduction abnormality, or myocardial infarction) that, in the investigator's judgment, would increase subject risk by participating in the clinical trial.\n3. SSc subjects: a) Uncontrolled severe pulmonary arterial hypertension (PAH) related to SSc; b) Rapidly progressive lower gastrointestinal tract (small and large intestine) involvement related to SSc requiring parenteral nutrition; active gastric antral vascular ectasia; c) Uncontrolled or rapidly progressive ILD with oxygen saturation (SaO2) \\\u003C92% on room air; or requiring mechanical ventilatory support within 1 year prior to signing informed consent.\n4. AAV subjects: a) Crescentic glomerulonephritis, acute polyneuritis, or central nervous system (CNS) involvement other than AAV at screening; b) Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.); c) Secondary vasculitis (e.g., SLE, Henoch-Schönlein purpura, drug-induced, malignancy-associated, infection-induced, primary immunodeficiency, etc.).\n5. SS subjects: a) Poorly controlled severe systemic primary Sjögren's syndrome (pSS) manifestations at baseline that, in the investigator's assessment, may place the subject at excessive risk; b) Secondary Sjögren's syndrome with other confirmed autoimmune diseases (e.g., rheumatoid arthritis, SLE, scleroderma, inflammatory bowel disease); c) Subjects requiring regular use of medications known to cause dry mouth\u002Fdry eye as common major side effects; d) Subjects with other diseases that may interfere with efficacy assessment of primary Sjögren's syndrome, such as inflammatory bowel disease, gout, sarcoidosis, amyloidosis, IgG4-related disease, etc. All subjects:\n6. Subjects with a history of severe hypersensitivity or anaphylaxis;\n7. Subjects with contraindications or hypersensitivity to any component of the investigational product;\n8. Subjects with any of the following cardiac diseases: a) New York Heart Association (NYHA) Class III or IV congestive heart failure; b) Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening; c) Clinically significant ventricular arrhythmia at screening, history of unexplained syncope not due to vasovagal reaction or dehydration, corrected QT interval (QTc) \\>480 ms, or history of severe non-ischemic cardiomyopathy;\n9. Subjects with any active malignancy or history of malignancy within 5 years prior to screening, excluding: early-stage tumors treated with curative intent (carcinoma in situ or Stage I tumor, non-ulcerated primary melanoma \\\u003C1 mm depth without lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or breast carcinoma in situ treated with potentially curative therapy;\n10. Subjects with any other known autoimmune disease other than the study disease;\n11. Subjects requiring long-term use of anticoagulants affecting coagulation function;\n12. Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; hereditary or acquired bleeding and thrombotic tendency (e.g., hemophilia, coagulopathy, hypersplenism, etc.); subjects with arterial or venous thrombotic events within 6 months prior to screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis and\u002For pulmonary embolism;\n13. Subjects with any severe underlying disease at screening, e.g.: a) Evidence of uncontrolled infection or viral, bacterial, fungal, or other infection treated with systemic intravenous antibiotics; b) Evidence of clinically significant dementia or altered mental status; c) History of any other central nervous system disease or neurodegenerative disease, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis;\n14. Subjects with positive screening results for any of the following: a) Positive human immunodeficiency virus (HIV) antibody; b) Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection of the assay; c) Positive hepatitis C virus (HCV) antibody with HCV RNA above the lower limit of detection of the assay; d) Active syphilis (excluding false-positive due to disease);\n15. Subjects with positive plasma cytomegalovirus (CMV) DNA or plasma Epstein-Barr virus (EBV) DNA (viral active);\n16. Subjects with active tuberculosis or untreated latent tuberculosis prior to screening;\n17. Subjects who received other investigational drugs within 4 weeks prior to signing informed consent form (ICF), or for whom the time from the last dose of a previous investigational drug to the date of signing ICF is less than 5 elimination half-lives of that drug (whichever is longer);\n18. Subjects who received plasmapheresis or immunoadsorption therapy within 4 weeks prior to dosing;\n19. Subjects who received B-cell targeted therapy within 6 months prior to dosing, including but not limited to belimumab, telitacicept, etc.;\n20. Subjects who received biologic therapy such as anti-TNF-α antibody within 12 weeks prior to dosing;\n21. Subjects who received tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to dosing;\n22. Subjects who received neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod) within 3 weeks prior to dosing;\n23. Subjects who received complement inhibition therapy (e.g., eculizumab) within 3 weeks prior to dosing;\n24. Subjects who received live attenuated vaccine or mRNA vaccine within 8 weeks prior to enrollment, or inactivated vaccine within 2 weeks prior to enrollment;\n25. Subjects who underwent major surgery within 8 weeks prior to screening or plan to undergo surgery during the study;\n26. Subjects with a history of organ\u002Fbone marrow\u002Fperipheral blood\u002Fumbilical cord blood transplantation;\n27. Subjects who previously received CAR-T product therapy targeting any target;\n28. Subjects with any condition that, in the investigator's judgment, may prevent completion of the entire study, interfere with study results, or make participation in the study not in the subject's best interest.","ALL","18 Years","65 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.",[27,28,29,30,31],"Systemic Lupus Erythematosus","Idiopathic Inflammatory Myopathies","Systemic Sclerosis (SSc)","ANCA-Associated Vasculitis (AAV)","Sjogren's Syndrome (SS)",[33],"MTS109","RECRUITING","2026-06-26",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":38},"2026-03-24",{"date":42,"type":21},"2029-04-01",{"name":44,"class":45},"Shanghai Changzheng Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100615687","phase-1-a-study-of-azd0120-in-autoimmune-diseases-100615687","NCT07295847","A Study of AZD0120 in Autoimmune Diseases","A Phase 1b, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19\u002FBCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases","AURORA","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Adequate physiological function and reserve at screening.\n* Able to comply with recommended medication washout period.\n* Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.\n* Willingness to remain on\u002Fstart appropriate, highly effective methods of birth control or other acceptable criteria.\n\nExclusion Criteria:\n\n* BMI at screening \\\u003C 18 or \\> 35kg\u002Fm2.\n* Any prior CAR T exposure.\n* Unable or unwilling to remain within proximity (\\~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration.\n* Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.\n* Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening.\n* Has certain heart conditions that could make it unsafe or unsuitable to take part in the study.\n* Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.\n* Uncontrolled hypertension (\\> 160\u002F100 mmHg) or symptomatic hypertension.\n* Any central nervous system disease that may impact participants safety in the investigator's opinion.\n* Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune\u002Fautoinflammatory diseases may be included after discussion with the medical monitor.\n* Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening\n* History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted.\n* Known genetic inborn error of immunity and\u002For primary immunodeficiency.\n* Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening.\n* Seropositive for HIV.\n* Active viral hepatitis are excluded.\n* Active syphilis, positive for Treponema pallidum antibody.\n* Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.\n* Not up-to-date on vaccinations per local\u002Fnational health authority or institutional guidelines for immune-compromised individuals.\n* Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide.\n* Contraindications or hypersensitivity to fludarabine and cyclophosphamide.\n* Major surgery, or has surgery planned during the study.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant.\n\nOther protocol-defined eligibility criteria may apply.","75 Years",{"count":57,"type":21},27,[59],"PHASE1","This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA\u002FCD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).",[62,28,63],"Systemic Sclerosis","Rheumatoid Arthritis",[62,28,63,65,66,67],"CAR-T","BCMA","CD19",{"date":69,"type":38},"2026-06-29",{"date":71,"type":38},"2026-01-09",{"date":73,"type":21},"2028-02-22",{"name":75,"class":76},"AstraZeneca","INDUSTRY",18,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100586548","phase-1-a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd5492-in-adult-participants-with-systemic-lupus-erythematosus-or-idiopathic-inflammatory-myopathies-or-rheumatoid-arthritis-100586548","NCT06916806","A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.","An Open-label, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis","TITAN","Inclusion Criteria:\n\n1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.\n2. Diagnosis of SLE:\n\n   1. Diagnosis of SLE according to the 2019 EULAR\u002FACR classification criteria for SLE\n   2. Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNA or anti-Sm at screening.\n   3. Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.\n   4. Intolerance to, or inadequate response following at least 3 months of use to, ≥ 3 available treatments, such as the following: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies.\n3. Diagnosis of IIM:\n\n   1. Must have \"probable\" or \"definite\" diagnosis of PM or DM (excluding IBM and cancer associated myositis) according to the 2017 EULAR\u002FACR classification criteria for adult myositis.\n   2. Positive for ≥ 1 disease-specific autoantibody at screening.\n   3. MMT-8 score of ≤ 142\u002F150 and\u002For CDASI-A ≥ 6\n   4. Fulfill at least one of the following criteria of active disease at screening:\n\n   (i) One or more muscle enzyme elevation (CK, AST, ALT, aldolase, LDH) ≥ 1.3 × ULN (ii) If criterion 3(d)(i) is not met, then at least one of the following criteria must be met: a. Report from MRI performed within 3 months prior to screening with evidence of muscle inflammation b. Report from muscle biopsy performed within 3 months prior to screening that demonstrates active inflammation c. Report from electromyography performed within 3 months prior to screening that exhibits irritable myopathic pattern.\n\n   (e) Intolerance or inadequate response to corticosteroids and ≥2 other SoC treatments, used for at least 3 months each, for which at least one must be a biologic SoC, immunoglobulin or cyclophosphamide.\n4. Diagnosis of RA:\n\n   (a) Diagnosis of RA as defined by the 2010 EULAR\u002FACR classification criteria (b) Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening: RF or ACPA (c) Moderate or severe disease activity defined as: (i) ≥6 tender joints and ≥6 swollen joints AND (ii) DAS28-CRP \\>3.2. (d) Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b\u002FtsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.\n\nExclusion Criteria:\n\n1. Any complications of the disease under study which are judged by the investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to:\n\n   1. Active severe SLE-driven renal disease.\n   2. History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or central\u002Fpulmonary venous clot) within 1 year prior to signing the ICF.\n   3. Rapidly progressive and\u002For severe ILD or ILD that requires oxygen supplementation\u002Ftherapy (of any type).\n   4. Inclusion Body Myositis or cancer associated myositis.\n2. Active severe, unstable or history of neuropsychiatric SLE.\n3. IIM: Pulmonary function tests at screening (or within one month of screening, provided participant confirms no change in respiratory symptoms in the interim) which meet any of the following criteria:\n\n   1. FVC ≤60% of predicted\n   2. DLCO ≤70% of predicted\n   3. Deterioration in either FVC or DLCO at screening compared to pulmonary function tests performed ≥3 months previously.\n4. Significant history of or at risk of severe infections.\n5. Participants with HIV infection.\n6. Participants with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive\n7. Participants with evidence of chronic or active hepatitis C\n8. Participants with positive COVID-19 PCR.\n9. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.\n10. Significant CNS pathology.\n11. Receipt of B-cell-depleting therapy including CD19 or CD20 directed monoclonal antibodies (including but not limited to, ocrelizumab, ofatumumab, obinutuzumab, or rituximab) \\\u003C3 months prior to Day 1.","70 Years",{"count":88,"type":21},72,[59],"The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA\n\nStudy details include:\n\n• The study duration will be a minimum of 180 days in addition to the screening period.\n\nAdditional follow-up visits may be required up to 12 months from study start.\n\n* Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2).\n* Study visits will occur at:\n\nScreening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.",[27,28,63],[93,94,95,96,97,98,99,100,101,102],"Lupus","Inflammatory Myopathy","Musculoskeletal Diseases","Neuromuscular Diseases","Nervous System Diseases","Muscular Diseases","Myositis","Dermatomyositis","Polymyositis","Arthritis","2026-06-24",{"date":105,"type":38},"2026-06-25",{"date":107,"type":38},"2025-05-01",{"date":109,"type":21},"2027-09-15",{"name":75,"class":76},37,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":46},"100423367","adult-autoimmune-myopathies-maia-100423367","NCT04792931","Adult Autoimmune Myopathies (MAIA)","Adult Autoimmune Myopathies (MAIA): Clinical and Immunological Characterization, Constitution of a Patient Library","MAIA","Inclusion Criteria:\n\n* Clinical suspicion of Adult Inflammatory Myopathy\n* Social security affiliation\n\nExclusion Criteria:\n\n* Pregnant and lactating women\n* Patients unable to consent\n* Patients refusing to participate in the research.\n* Patients under legal protection",{"count":121,"type":21},60,[123],"NA","This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy. It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle specimen.",[28],{"date":105,"type":38},{"date":128,"type":38},"2022-05-20",{"date":130,"type":21},"2030-05-20",{"name":132,"class":45},"University Hospital, Brest",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":154,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":46},"100598885","eacvi-study-on-multimodality-cardiovascular-imaging-of-inflammatory-cardiovascular-diseases-100598885","NCT07077304","EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases","EACVI-INFLAME","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ability to provide informed non-opposition\n3. Referred for a CMR and\u002For nuclear imaging exam\n\nAND a suspicion of one of the following ICARDs :\n\n1. Suspected Myocarditis (acute or chronic, and whatever the aetiologies)\n2. Suspected Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA)\n3. Suspected Tako-Tsubo\n4. Suspected Pericarditis (acute or chronic, and whatever the aetiologies)\n5. Suspected Connective tissue disease with cardiovascular involvement:\n\n   * Systemic sclerosis\n   * Systemic lupus erythematosus\n   * Antiphospholipid syndrome\n   * Idiopathic inflammatory myopathies\n   * Rheumatoid arthritis, spondylarthritis\n6. Suspected Vasculitis with cardiovascular involvement:\n\n   * Small-vessel vasculitis (ANCA…)\n   * Large vessel vasculitis (Behcet disease, Takayasu…)\n7. Suspected Inflammatory disease with cardiovascular involvement:\n\n   * Sarcoidosis\n   * Still disease\n\nExclusion Criteria:\n\n1. Inability to provide non-opposition\n2. History of heart transplant",{"count":141,"type":21},5000,"OBSERVATIONAL","Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases (ICARDs) encompass cardiovascular involvement in connective tissue diseases, vasculitis, and primary inflammatory cardiac processes affecting all layers of the heart. ICARDs are associated with increased cardiovascular morbidity and mortality, independently of traditional risk factors, via multiple pathophysiological mechanisms.\n\nDiagnosis and prognosis are challenged by the heterogeneity of clinical presentations. Multimodality cardiovascular imaging - including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, and positron emission tomography (PET) - plays a central role in detecting and characterizing inflammatory involvement, and may offer prognostic insights.\n\nGiven the limited data on the diagnostic and prognostic utility of these imaging modalities in ICARDs, the EACVI-INFLAME study aims to assess the prevalence of confirmed cardiovascular involvement in patients with suspected or established ICARDs undergoing CMR and\u002For cardiac PET in a multicentric international cohort.",[145,146,147,62,27,28,63,148,149,150,151,152,153],"Myocarditis","ANCA Associated Vasculitis","Pericarditis","Spondylarthritis","Behcet Disease","Takayasu Arteritis","Sarcoidosis","Still Disease","Tako Tsubo Cardiomyopathy",[155,156,157,158,159,160,161,162],"Cardiovascular disease","Auto-immune disease","Auto-inflammatory disease","Rheumatic disease","CMR","PET","multimodality imaging","ICARD","2026-06-03",{"date":165,"type":38},"2026-06-05",{"date":167,"type":38},"2025-11-19",{"date":169,"type":21},"2028-10-30",{"name":171,"class":45},"Assistance Publique - Hôpitaux de Paris",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100572489","phase-1-a-phase-12-study-of-nkx019-in-subjects-with-immune-mediated-diseases-ntrust-2-100572489","NCT06733935","A Phase 1\u002F2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)","A Phase 1\u002F2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases","General Inclusion Criteria:\n\n1. Age ≥18 and ≤75\n2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements\n3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose\n4. For participants taking corticosteroids, the prednisone (or equivalent) dose must be ≤20 mg\u002Fday at 2 weeks prior to Screening and stable for ≥ 14 days before start of Screening\n5. For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening\n6. eGFR as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥45 mL\u002Fmin\u002F1.73 m2 at screening\n\nSSc Inclusion Criteria:\n\n1. Meets the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc\n2. Meet criteria a and\u002For b:\n\n   a. Severe skin involvement defined as mRSS ≥ 30 or active skin disease defined as mRSS ≥ 15 at screening and one or more of the following within the prior 6 months of screening:\n\n   i. An increase in mRSS of ≥ 3 units\n\n   ii. Involvement of 1 new body area with ≥ 2 mRSS units\n\n   iii. 2 new body areas with ≥ 1 mRSS unit\n\n   b. Moderate to severe Interstitial Lung Disease (ILD) defined by evidence of ILD on High-resolution computed tomography (HRCT) and FVC \\\u003C 70% of predicted or DLCO (hemoglobin or alveolar volume corrected) \\\u003C 70% of predicted or ILD on HRCT and progressive ILD meeting at least 2 of the following 3 criteria within the prior 6 months of screening:\n\n   i. Worsening respiratory symptoms\n\n   ii. Evidence of progression on HRCT, or\n\n   iii. Evidence of absolute decline in FVC ≥ 5%\n3. 10 years or less since the first non-Raynaud's sign or symptom\n4. Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF\u002Fmycophenolic acid, nintedanib, rituximab, or tocilizumab\n\nIIM Inclusion Criteria:\n\n1. Diagnosis for IIM as per 2017 ACR\u002FEULAR Classification Criteria\n2. One positive myositis antibody\n3. Activity defined as manual muscle testing (MMT-8) score \\\u003C136\u002F150\n4. Creatinine kinase or aldolase ≥ 1.5 x ULN and Clinician Global Assessment ≥ 2 cm with at least one of the following:\n\n   1. Evidence on magnetic resonance imaging (MRI) of active myositis within the last 6 months\n   2. Electromyography (EMG) with active myositis within the last 6 months\n   3. Muscle Biopsy of active myositis within last 6 months\n   4. Global extramuscular activity score ≥2 cm per Clinician global assessment (CGA) using a visual analog scale (VAS) (0-100 mm)\n\n   Note: Participants with DM or ASyS may be eligible despite CK or aldolase \\\u003C1.5 × ULN, provided they have a Clinician Global Assessment ≥2 cm and meet at least one of criteria (a)-(d) above OR have a CDASI score of ≥20.\n5. Inadequate response to treatment defined as ≥ 3 months failure (or intolerance) to at least 2 immunosuppressive therapies (including glucocorticoids)\n\nAAV:\n\n1. Meets the 2022 ACR\u002FEULAR classification criteria for Granulomatosis with Polyangiitis (GPA) (Robson 2022) or Microscopic Polyangiitis (MPA) (Suppiah 2022)\n2. Relapsed or refractory AAV despite repeated treatment with immunosuppressive agents or requiring prolonged and\u002For repeated courses of unacceptable doses of glucocorticoids to maintain disease control\n3. Positive test for anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening\n4. Have at least one \"major\" item, or at least 3 other items, or at least 2 renal items on the BVAS version 3\n\nRA Inclusion Criteria:\n\n1. Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria\n2. Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive\n3. CRP \\>3 mg\u002FL\n4. Inadequate response, defined as failure to achieve a clinically meaningful improvement (eg, ACR50 response or DAS28-low disease activity \\[ie, DAS28 \\>3.2\\]) after at least 12 weeks of therapy with the following:\n\n   1. At least 1 conventional synthetic DMARD (csDMARD) (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) AND\n   2. Either of the following:\n\n   i. At least 2 biologic (b) DMARDs (eg, TNF inhibitors, abatacept, anti-IL-6 or anti-IL-6R, rituximab) with distinct mechanisms of action (MoAs)\n\n   OR\n\n   ii. At least 1 bDMARD and at least 1 targeted synthetic DMARD (tsDMARD) (eg, JAK inhibitor)\n\n   AND\n\n   c. Have failed no more than 3 biologics or tsDMARDs with unique mechanisms of action\n5. Minimum of 6 swollen joint counts (SJCs) and 6 tender joint counts (TJCs) according to joint assessment\n\nGeneral Exclusion Criteria:\n\n1. eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2\n2. Currently requiring renal dialysis or expected to require dialysis during the study period\n3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period\n4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy\n5. Liver disease or dysfunction, including cirrhosis and\u002For bilirubin ≥ 3 times the upper limit of normal\n6. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\\\u003C92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \\>10 pack\u002Fyear) with active pulmonary disease\n7. Participants with ILD with any of the following:\n\n   1. Requires supplemental oxygen therapy\n   2. FVC \\\u003C45% of predicted\n   3. Diffusing capacity of the lung (DLCO) corrected for alveolar volume (AV) or Hemoglobin (Hgb) ≤ 40% of predicted at screening (per Investigator or Sponsor judgement)\n\n   i. If the participant has a historical FVC value within the last year that exceeds the 45% threshold, discuss with the Medical Monitor should the Screening FVC be \\\u003C45% predicted\n8. Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \\\u003C 3,000\u002Fmm\\^3; hemoglobin levels ≤ 9 g\u002FdL; absolute neutrophil count (ANC) ≤ 1500\u002Fmm\\^3; platelet count ≤ 100,000\u002Fmm\\^3, and blood transfusion within 60 days prior to LD\n9. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:\n\n   1. Uncontrolled angina or unstable life-threatening arrhythmias\n   2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019\n   3. Any prior coronary artery bypass graft surgery\n   4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency\n   5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \\> 480 msec\n   6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019\n10. Active bleeding disorders\n11. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis or any condition for additional immunosuppression is indicated); clinically significant conditions that could cause a secondary nephropathy (eg, infections, liver disease, tumors or drugs); or kidney biopsy-confirmed significant renal disease other than disease under study (eg, diabetic nephropathy, hypertensive nephropathy). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoid arthritis) are not excluded\n12. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions\n13. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD\n14. History of positive HIV test at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy\n15. Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the participant has not recovered or has ongoing complications\n16. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed\n17. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells\n18. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as evidence of CNS related autoimmune manifestations within 1 year prior to screening\n\nSSc Exclusion Criteria:\n\n1. Moderate-to-severe Pulmonary arterial hypertension (PAH) on right heart catheterization requiring PAH specific treatment. Those participants with mild PAH (as defined by the 2022 ECS\u002FERS Guidelines, \\[Humbert 2023\\]) well controlled on therapy can be enrolled\n2. Gastrointestinal (GI) dysmotility requiring total parenteral nutrition (TPN)\n3. Renal crisis or Pericardial tamponade within 6 months prior to enrollment\n4. Current gangrene of a digit\n\nIIM Exclusion Criteria:\n\n1. Evidence of severe chronic proximal muscle involvement of upper or lower extremities, based on Magnetic Resonance Imaging (MRI) defined as:\n\n   1. ≥15% fibro-fatty replacement in core muscle groups (including gluteus and vastus musculature), and\u002For\n   2. ≥15% muscle atrophy in these regions Participants will also be excluded if the combined extent of fibro-fatty replacement and muscle atrophy exceeds 30% in aggregate\n2. MMT-8 of ≤ 80\n3. Findings of muscular inflammation or myopathy due to another cause, such as inclusion body myositis, cancer-associated myositis (myositis diagnosed within 2 years of cancer), amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic IIM rheumatologic disease (overlap myositis), except with Sjögren's syndrome\n4. Generalized severe musculoskeletal or neuro-muscular conditions other than IIM\n5. Immune-mediated necrotizing myopathy\n\nAAV Exclusion Criteria:\n\n1. Alveolar hemorrhage requiring invasive pulmonary ventilation support\n2. Required dialysis or plasma exchange within 12 weeks prior to screening\n3. Any other known disease that may interfere with the assessments including eosinophilic GPA (Churg-Strauss), anti-glomerular basement membrane, systemic lupus erythematosus, IgA vasculitis (Henoch Schönlein), rheumatoid vasculitis, or cryoglobulinemic vasculitis",{"count":180,"type":21},240,[59,182],"PHASE2","This is a Phase 1\u002F2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.",[62,28,185,63],"Antineutrophil Cytoplasmic Antibody-Associated Vasculitis",[67,187,188,189,190,191,192,193,194,195,196,99,197,62,28,198,199,63],"CAR","Allogeneic","NKX019","Natural Killer Cells","Interleukin-15","IL-15","Cell Therapy","Immunotherapy","Adoptive cell therapy","Scleroderma","AAV","Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Ntrust-2","2026-06-02",{"date":202,"type":38},"2026-06-04",{"date":204,"type":38},"2024-11-04",{"date":206,"type":21},"2028-10",{"name":208,"class":76},"Nkarta, Inc.",17,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":217,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":236,"locationsCount":46},"100614838","phase-1-a-phase-1-open-label-study-to-evaluate-safety-in-healthy-participants-and-participants-with-autoimmune-diseases-100614838","NCT07284797","A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases","A Phase 1, First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of XmAb657 in Healthy Participants and in Participants With Autoimmune Diseases","Inclusion Criteria:\n\nHealthy participants - Adult participants in good health\n\nIdiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criterion for IIM\n\nSystemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR\u002FEULAR Classification Criteria for SSc\n\nSjogren's Disease participants that meet the 2016 ACR\u002FEULAR Classification Criteria for Primary Sjogren's Syndrome\n\nAll participants - Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to dosing or planned within the study\n* Recurrent infections or active clinically significant infection\n* Active or untreated latent tuberculosis\n* Cancer or history of cancer or lymphoproliferative disease within the previous 5 years\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n\nNote: Additional, more specific inclusion\u002Fexclusion criteria are defined in the protocol.",true,{"count":121,"type":21},[59],"The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.",[222,28,62,223],"Healthy","Sjögren's Disease",[225,99,196,226,227,228,229],"Myopathy","Autoimmune Diseases","IIM","SjD","SSc","2026-05-20",{"date":232,"type":38},"2026-05-22",{"date":234,"type":38},"2026-02-24",{"date":206,"type":21},{"name":237,"class":76},"Xencor, Inc.",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":252,"overallStatus":254,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100640182","early-phase-1-cd19bcma-targeted-universal-car-t-cell-injection-for-the-treatment-of-autoimmune-diseases-100640182","NCT07596680","CD19\u002FBCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases","Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CD19\u002FBCMA-Targeted CAR-T Cell Injection in Patients With Autoantibody-Mediated Autoimmune Diseases","Inclusion Criteria\n\n1. General Inclusion Criteria (All Patients)\n\n   1. Voluntarily provides written informed consent.\n   2. Age ≥18 and ≤70 years, any gender.\n   3. Adequate organ function:\n\n      * ALT and AST ≤3×ULN; total bilirubin ≤2×ULN (excluding Gilbert syndrome).\n      * Creatinine ≤1.5×ULN or creatinine clearance ≥40 mL\u002Fmin.\n      * Neutrophils ≥1×10⁹\u002FL; hemoglobin ≥60 g\u002FL; platelets ≥20×10⁹\u002FL; lymphocytes \\>0.3×10⁹\u002FL.\n      * INR ≤1.5×ULN or PT ≤1.5×ULN.\n      * Resting room-air SpO₂ ≥92%.\n      * LVEF ≥50% on echocardiogram.\n   4. Negative serum or urine pregnancy test for females of childbearing potential at screening.\n   5. Highly effective contraception required from 28 days before lymphodepletion until 12 months after RD06-05 infusion for females; effective barrier contraception required from lymphodepletion until 12 months after RD06-05 infusion for males, with no sperm donation during the study.\n2. For SLE Patients\n\n   1. Diagnosis of SLE per 2019 EULAR\u002FACR or 2012 SLICC criteria.\n   2. Active disease despite ≥2 months of stable (≥2 weeks) treatment with glucocorticoids plus immunosuppressants and\u002For biologics; prednisone ≥7.5 mg\u002Fday or equivalent.\n   3. Positive ANA, anti-dsDNA antibody, and\u002For anti-Smith antibody at screening.\n   4. SLEDAI-2K \\>6 and clinical SLEDAI-2K ≥4 at screening. Patients with lupus nephritis (proteinuria \\>0.5 g\u002F24h, UPCR \\>500 mg\u002Fg, or active urinary sediment) are exempt from clinical SLEDAI-2K requirement.\n   5. Physician Global Assessment (PGA) ≥1.0 (0-3 VAS) at screening.\n3. For SSc Patients\n\n   1. Diagnosis of SSc per 2013 ACR\u002FEULAR criteria.\n   2. Diffuse cutaneous SSc at screening.\n   3. Active disease defined by at least one of: new SSc within 2 years; new\u002Fworsening skin or thoracic\u002Fabdominal involvement within 6 months; worsening skin thickening (mRSS ≥2); tendon friction rubs within 3 months; worsening respiratory symptoms with FVC decline ≥5% predicted or DLCO decline ≥10% predicted; or ILD progression on HRCT compared to 12 months prior.\n   4. Refractory or relapsing disease after \\>6 months of conventional therapy including glucocorticoids, cyclophosphamide, immunosuppressants, and\u002For biologics.\n4. For AAV Patients\n\n   1. Diagnosis of ANCA-associated vasculitis (MPA, GPA, EGPA) per 2022 ACR\u002FEULAR criteria.\n   2. Positive MPO-ANCA or PR3-ANCA.\n   3. BVAS with at least 1 major item, 3 minor items, or 2 renal items.\n   4. Failure of standard of care: no remission after ≥4 months of glucocorticoids plus cyclophosphamide\u002Frituximab; relapse after prior remission; or persistent active disease despite ≥6 months of SOC.\n5. For IIM Patients\n\n   1. Diagnosis of IIM (DM, ASS, IMNM) per 2017 ACR\u002FEULAR criteria (probability ≥55%).\n   2. Active disease defined by ≥2 abnormal core measures, or active myositis on muscle MRI, or active inflammation on muscle biopsy within 16 weeks.\n   3. Positive myositis-specific autoantibodies.\n   4. Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and\u002For biologics.\n6. For pSS Patients\n\n   1. Diagnosis of primary Sjögren's syndrome per 2016 ACR\u002FEULAR criteria.\n   2. Positive anti-SSA\u002FRo antibody.\n   3. ESSDAI ≥6 at screening.\n   4. Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and\u002For biologics.\n\nExclusion Criteria:\n\n1. General Exclusion Criteria (All Patients):\n\n   1. Coexisting autoimmune disease confounding disease activity\u002Fsafety (stable ≥3 months may be eligible with approval).\n   2. Anti-CD20 mAb\u002FT-cell engager within 3 months; CD19\u002FBCMA-targeted therapy within 6 months (exception with CD19⁺ B-cell \\> LLN and approval).\n   3. Rapidly progressive glomerulonephritis (RPGN).\n   4. NYHA III\u002FIV heart failure; severe cardiac disease within 12 months.\n   5. Severe CNS disease impairing compliance\u002Fassessments.\n   6. Malignancy history (except cured non-melanoma skin cancer\u002Fcarcinoma in situ, disease-free ≥3 years).\n   7. Primary immunodeficiency.\n   8. Uncontrolled infection (uncomplicated UTI\u002Fupper respiratory infection permitted).\n   9. Positive HIV; positive HCV (except undetectable RNA); positive syphilis.\n   10. Positive HBsAg; positive HBcAb (except undetectable HBV DNA).\n   11. Positive EBV\u002FCMV DNA\u002FIgM at screening.\n   12. Active\u002Frecurrent tuberculosis.\n   13. Prior CAR-T or genetically modified immune cell therapy.\n   14. Live attenuated vaccine within 4 weeks before enrollment.\n   15. Hypersensitivity to cell therapy product components.\n   16. Tacrolimus hypersensitivity or ≥Grade 3 toxicity requiring hospitalization.\n   17. Other clinical trial participation within 30 days before screening.\n   18. Pregnant\u002Fbreastfeeding; childbearing potential unwilling to use effective contraception.\n   19. Any other ineligible condition (investigator judgment).\n2. Exclusion Criteria for SLE\n\n   1. Active\u002Funstable neuropsychiatric SLE requiring intervention within 90 days.\n   2. Anti-BAFF\u002FAPRIL therapy within required washout period; multiple NSAIDs within 14 days; inability to hold NSAIDs; intra-articular glucocorticoids within 6 weeks; immunosuppressants exceeding dose limits; hydroxychloroquine dose adjustment within 8 weeks; ACEI\u002FARB\u002FSGLT2i adjustment within 4 weeks.\n3. Exclusion Criteria for AAV\n\n   1. Alveolar hemorrhage requiring invasive ventilation beyond screening.\n   2. Dialysis\u002Fplasmapheresis within 12 weeks.\n   3. Renal transplantation history.\n   4. Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.\n   5. High-dose IV glucocorticoids within 4 weeks.\n   6. Oral glucocorticoids \\>60mg prednisone equivalent daily for \\>6 weeks.\n   7. Specific immunosuppressants\u002Fbiologics within 4 weeks.\n   8. Concomitant strong CYP3A4 inducers.\n4. Exclusion Criteria for IIM\n\n   1. Severe rhabdomyolysis or CK ≥120×ULN at screening.\n   2. FVC ≤50% predicted or DLCO ≤40% predicted at screening.\n5. Exclusion Criteria for SSc\n\n   1. Significant respiratory disease other than ILD.\n   2. FVC \\\u003C50% or DLCO \\\u003C40% predicted at screening\u002Fbaseline.\n   3. Lung transplantation listing\u002Fexpected within 12 months.\n   4. Scleroderma renal crisis within 6 months.\n   5. Scleroderma-like disorders.\n   6. Prior chlorambucil, bone marrow transplantation, or total lymphoid irradiation.\n6. Exclusion Criteria for pSS\n\n   1. Active fibromyalgia interfering with assessment\u002Frequiring medication adjustment (stable permitted).\n   2. Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.\n   3. High-dose glucocorticoids (≥60mg\u002Fday) within 4 weeks.",{"count":246,"type":21},30,[24],"This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others.\n\nThe CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells\u002Fkg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.",[250,62,146,28,251],"SLE - Systemic Lupus Erythematosus","Sjögren Syndrome",[253],"CD19\u002FBCMA CAR-T","NOT_YET_RECRUITING","2026-05-12",{"date":257,"type":38},"2026-05-19",{"date":259,"type":21},"2026-04-30",{"date":261,"type":21},"2029-04-30",{"name":263,"class":76},"Nanjing Bioheng Biotech Co., Ltd.",2,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100538031","phase-2-drug-rediscovery-for-rare-immune-mediated-inflammatory-diseases-100538031","NCT06285539","Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases","DRIMID","Inclusion Criteria:\n\n* Age 18 years of older\n* One of the following rare IMIDs:\n\n  * Diagnosis of Behçet's disease without refractory life, organ or sight-threatening symptoms with active disease, defined as a BDCAF \\>2 (new BDCAF) or \\>15 (old BDCAF) or with active disease, based on clinical grounds (e.g. the need to start new or additional medication\n  * Diagnosis of idiopathic inflammatory myopathy, according to diagnostic criteria:\n\nDermatomyositis: Dermatomyositis Classification Criteria according to the European Neuromuscular Centre guidelines 201852 or anti-synthetase syndrome: Anti- synthetase syndrome Classification Criteria according to the European Neuromuscular Centre guidelines 200353, both with active disease, defined as a CDASI score of ≥5 or abnormal levels of at least 1 of the following enzymes: creatine kinase (≥ 4× upper limit of normal \\[ULN\\]), aldolase (≥4 × ULN), lactate dehydrogenase (LDH ≥4 × ULN), aspartate transaminase (AST ≥4 × ULN), alanine aminotransferase (ALT ≥4 × ULN) or a MRI within the last 3 months indicative of active inflammation (e.g. edema signal pattern in affected proximal muscles) or active disease based on clinical grounds, e.g. the need to start new or additional medication\n\n* Diagnosis of IgG4-related disease, according to 2019 ACR\u002FEULAR guidelines, with active disease, defined as: IgG4-related disease responder index \\>10 or active disease based on clinical grounds, e.g. the need to start new or additional medication\n\n  * Refractory disease, defined as symptomatic disease that persists despite a 12-week trial of glucocorticoid therapy as well as lack of response to at least one other immunosuppressive agent such as methotrexate (MTX), mycophenolate mofetil (MMF), azathioprine (AZA) or rituximab or intolerance to standard-of-care treatment, as defined by the treating physician.\n  * No evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (TB) as defined by all of the following: both a negative QuantiFERON-TB Gold (QFT-G) In-Tube test and a Mantoux tuberculin skin test performed at or within 3 months prior to screening and no signs suggestive of active TB infection as determined (and documented) by a qualified radiologist or pulmonologist as per local standard of care on a chest radiograph and no history of either untreated or inadequately treated latent or active TB infection.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Age ≥65 years\n* Life expectancy less than 6 months\n* Juvenile DM, myositis overlapping with other autoimmune diseases, immune mediated necrotizing myopathy (IMNM), inclusion-body myositis or cancer-associated myositis\n* End-stage IIM wherein muscle weakness is most likely due to muscle damage, rather than myositis disease activity\n* Increased risk of major cardiovascular problems\n* Current smoker or smoked for a long time in the past\n* Pregnancy or lactation\n* Previous use of other JAK inhibitors\n* Use of any investigational drug within one month prior to screening or within five half-lives of the investigational agent, whichever is longer.\n* Human Immunodeficiency Virus (HIV) infection\n* Presence of an active infection or viral hepatitis type B or C\n* History of shingles or recurrent herpes simplex infection\n* Concomitant malignancies or previous malignancies within the last five years (with exception of adequately treated basal or squamous cell carcinoma of the skin)\n* Increased risk of cancer\n* Kidney injury with estimated glomerular filtration rate \\\u003C15mL\u002Fmin\u002F1.73m2\n* Liver failure Child Pugh C\n* Absolute neutrophil count \\\u003C1\\*109\n* Absolute leukocyte count \\\u003C0.5\\*109\n* Hemoglobin \\\u003C5mmol\u002FL - Inability to comply with study and\u002For follow-up procedures\n* Known recent substance abuse (drugs or alcohol).\n* Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.\n* Previous non-adherence to immunosuppressants\n* Hypersensitivity to the active substance or to any of the excipients\n* Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption",{"count":121,"type":21},[182],"Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations. Patients with Behçet's disease (BD), idiopathic inflammatory myopathy (IIM, also known as myositis) and IgG4-related disease (IgG4-RD) are treated with high-dosed glucocorticoids, methotrexate, azathioprine and mycophenolate mofetil, mostly for long periods of time with attendant risks of long-term toxicity, including infections. Therefore, there is an urgent need for new, more specific anti-inflammatory therapies such as targeted synthetic and biological disease-modifying antirheumatic drugs. Due to the role of type 1 interferon in both BD, IIM and IgG4-RD, JAK-STAT inhibition may be a promising treatment strategy in these conditions, because JAK1 is critical for the signal transduction of pro-inflammatory cytokine receptors. Previous research showed that JAK1 inhibition reduces activation of type 1 interferon-regulated proteins and key chemokines that control tissue inflammation.",[276,28,277],"Behcet's Disease","IgG4-related Disease",[279],"JAK-inhibition","2026-05-07",{"date":255,"type":38},{"date":283,"type":38},"2024-03-12",{"date":285,"type":21},"2027-12",{"name":287,"class":45},"UMC Utrecht",6,{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":46},"100558245","early-phase-1-clinical-study-on-targeted-cd19-or-cd19-bcma-car-t-therapy-for-autoimmune-diseases-100558245","NCT06548607","Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×10\\^9\u002FL, lymphocyte count \\>0.3×10\\^9\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after CAR-T reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of CAR-T and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":296,"type":21},20,[24],"This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.",[300,62,146,28,301,226],"SLE (Systemic Lupus)","Sjogren's Syndrome","2026-03-04",{"date":304,"type":38},"2026-03-06",{"date":306,"type":38},"2024-09-14",{"date":308,"type":21},"2027-12-31",{"name":263,"class":76},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":317,"enrollmentInfo":318,"targetDuration":320,"studyType":142,"phases":4,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":254,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":46},"100618559","tongji-nads-cohort-100618559","NCT07333196","Tongji NADs Cohort","Tongji NADs Cohort: A Real-world Observation of Neurological Autoimmune Disorders","Inclusion Criteria:\n\n* Participants must meet the following eligibility criteria at the time of screening to participate in this study.\n\n1.1. The subject is able to understand the purpose and risks of the study, provide informed consent and authorize the use of confidential health information in accordance with national and local privacy regulations.\n\n1.2. Open to both men and women, aged 18-80 years (inclusive) at the time of informed consent.\n\n1.3. Must be diagnosed with one of the following conditions:\n\n1.3.1. This study adhered to the 2017 McDonald criteria for diagnosing multiple sclerosis:\n\n1. ≥2 clinical episodes with ≥2 objective clinical evidences of lesions.\n2. ≥2 clinical episodes with one clear historical evidence of the lesion involving specific anatomical site.\n3. ≥2 clinical episodes with objective clinical evidence of one lesion, and spatial multiplicity confirmed by clinical episodes in different CNS sites or MRI findings.\n4. A single episode with ≥2 objective clinical evidences, confirmed by additional clinical episodes or MRI showing temporal multiple lesions or OCB positivity.\n5. A single episode with one objective clinical manifestation, confirmed by clinical seizures or MRI scans across multiple CNS regions to demonstrate spatial multiplicity, and further supported by additional clinical episodes or MRI findings to confirm temporal multiplicity or OCB positivity.\n6. Indication for the progressive multifocal sclerosis (PPMS) phase: Disease progression at 1 year (confirmed retrospectively or prospectively), with two of the following three criteria: \\[1\\] Spatially multifocal evidence of brain lesions: ≥1 T2-weighted lesion in characteristic MS regions (periventricular, corticoprotuberant, or subarachnoid) \\[2\\] Spatially multifocal evidence of spinal lesions: ≥2 T2-weighted lesions in the spinal cord \\[3\\] OCB positivity.\n\n1.3.2. This study adhered to the 2015 IPND diagnostic criteria for adult neuromyelitis optica spectrum disorders:\n\n1. NMOSD diagnosis with AQP4-IgG positivity: meeting ≥1 core clinical feature, confirmed by reliable AQP4-IgG detection (CBA method recommended), and excluding other diagnoses.\n2. Diagnostic criteria for NMOSD with AQP4-lgG negative or undetermined status: In at least one clinical episode, the presence of ≥2 core clinical features meeting all of the following criteria: ①≥1 core clinical feature is ON, acute LETM, or bulbar syndrome; ②≥2 distinct core clinical features; ③MRI supplementary criteria are satisfied. AQP4-lgG should be reliably detected as negative or undetected, and other diagnoses must be excluded.\n\nNote: Core clinical features include six cardinal signs: optic neuritis (ON), acute myelitis (LETM), and the final area syndrome (unexplained paroxysmal hiccups, nausea, and vomiting); other brainstem syndromes; symptomatic narcolepsy\u002Fhypothalamic syndrome with characteristic hypothalamic MRI lesions; and brain syndrome with characteristic cerebral MRI lesions.\n\nMRI diagnostic criteria: Acute optic neuritis (ON) requires MRI demonstrating one of the following: ① Normal brain MRI or non-specific white matter lesions; ② Long T-weighted signal or T-weighted enhancement exceeding 1\u002F2 of optic nerve length, or optic chiasm involvement; ③ Acute myelitis (LETM) requires three or more consecutive vertebral segments with spinal cord lesions, or spinal cord atrophy exceeding three consecutive vertebral segments in patients with myelitis history; ④ Final region syndrome: lesions in the dorsal medulla or final region. Acute brainstem syndrome: periventricular lesions in the brainstem.\n\n1.3.3. This study adhered to the MOGAD diagnostic criteria established by the International Parkinson's Disease and Movement Disorders (IPMD) in 2023:\n\n1. A diagnosis of MOGAD can be confirmed when: (a) fixed or live-cell CBA detects strong positivity of MOG-IgG in serum with ≥1 core clinical manifestation, and (b) other diagnoses (e.g., MS, NMOSD) are excluded;\n2. If the CBA shows weak positivity of MOG-IgG in serum, or MOG-IgG positivity without titer, or negative serum MOG-IgG with strong positivity in cerebrospinal fluid (CSF), the diagnosis requires: 1) ≥1 core clinical manifestation, 2) ≥1 supporting clinical or imaging feature, 3) negative serum AQP4-IgG, and 4) exclusion of other diagnoses (e.g., MS, NMOSD).\n\nNote: The core clinical features include six main signs: optic neuritis, myelitis, acute disseminated encephalomyelitis, monofocal or multifocal cerebral dysfunction, brainstem or cerebellar functional deficits, and cerebral cortex inflammation with epilepsy.\n\nTypical MRI imaging features: ① Optic Neuropathy (ON): Bilateral optic nerve involvement with long-segment optic nerve damage (\\>50% optic nerve length), optic nerve sheath enhancement, and papilledema. ② Myelitis: Long-segment transverse myelitis with central spinal cord damage or \"H\" sign, and conus medullaris damage. ③ Cerebral, brainstem, or cerebral cortex symptoms: Multifocal ill-defined T2 hyperintense lesions in supratentorial and infratentorial white matter, deep gray matter involvement, ill-defined T2 hyperintense lesions in pons, cerebellar midfoot, or medulla oblongata, and cortical lesions with or without focal enhancement and local dural enhancement.\n\nThe strong positive result of serum and cerebrospinal fluid MOG-IgG was defined as the value of the live CBA was more than 2 times the detection limit or the fixed CBA titer was ≥1:100. The weak positive result was defined as the value of the live CBA was in the lower range or the fixed CBA titer was ≥1:10 but less than 1:100.\n\n1.3.4. This study followed the expert consensus on the diagnosis and treatment of autoimmune encephalitis in China (2022 edition)\n\n1. Possible AE: meeting the following three diagnostic criteria A, B, and D; confirmed AE: meeting the four diagnostic criteria A, B, C, and D.\n2. Diagnostic criteria:\n\nA. Clinical presentation: Acute or subacute onset (\\\u003C3 months) with ≥1 of the following neurological or psychiatric symptoms or clinical syndromes: limbic system symptoms, encephalitis syndrome, lymphocytic inflammation in cerebrospinal fluid cytology, and positive specific oligoclonal bands.\n\nB. Neuroimaging or electrophysiological abnormalities: T2 or FLAIR abnormal signals in the limbic system (unilateral or bilateral), or T2\u002FFLAIR abnormalities in other regions (excluding nonspecific white matter changes and stroke); or PET findings of high metabolism in the limbic system, or multiple high metabolic areas in the cortex and\u002For basal ganglia; or EEG abnormalities such as focal epilepsy or epileptiform discharges (in the temporal lobe or outside it), or diffuse or multifocal slow-wave rhythms.\n\nC. Diagnostic test: Positive for anti-neuronal antibodies. D. Reasonably rule out other possible causes.\n\n1.3.5. This study adhered to the diagnostic criteria for AIDP, CIDP, and autoimmune Ranvier node disease:\n\n1. AIDP: Essential features include: ① Progressive weakness in the upper and\u002For lower limbs, ranging from mild bilateral lower limb weakness to complete paralysis of all limbs (including trunk, medullary muscles, and facial muscles) and oculomotor muscle paralysis; ② Weakened or absent deep tendon reflexes in the affected limbs; ③ Symptom progression ≤4 weeks. Supporting features include: ① Symptom progression from days to 4 weeks; ② Relatively symmetrical bilateral symptoms; ③ Trunk or limb pain; ④ Cranial nerve symptoms or signs; ⑤ Autonomic dysfunction; ⑥ Respiratory insufficiency; ⑦ Mild or absent sensory dysfunction; ⑧ History of prodromal systemic infection in approximately 70% of cases; ⑨ No fever at symptom onset; ⑩ Elevated cerebrospinal fluid protein with normal or mildly elevated white blood cell count (\\\u003C5 mm³); ⑪ Electrophysiological examination showing abnormalities consistent with Guillain-Barré syndrome (GBS); ⑫ Recovery begins 2-4 weeks after symptom stabilization.\n2. CIDP: CIDP develops in 2%-5% of patients initially diagnosed with AIDP, with the following clinical features: ① Progressive or recurrent disease progression lasting over 8 weeks; ② Only approximately 30% of patients experience prodromal events; ③ Additional supporting features include: ≥3 acute relapses or exacerbations occurring ≥8 weeks after symptom onset, milder symptoms, preserved independent walking ability throughout the disease course, and absence of cranial nerve involvement or frequent respiratory system involvement.\n3. Autoimmune Ranvier node disease:\n\n   * Clinical manifestations: a. Acute, subacute or chronic course, with persistent progression after 8 weeks of onset; b. Clinical features consistent with polyneuropathy; c. May be accompanied by significant ataxia, tremor or neuropathic pain; d. May be associated with nephrotic syndrome.\n   * Electrophysiological findings: a. Motor nerve conduction tests reveal prolonged distal motor latency, slowed conduction velocity, abnormal waveform dispersion, and conduction block, with decreased F-wave conduction velocity, consistent with myelination abnormalities; b. Both motor and sensory nerve conduction show markedly reduced amplitude. Electromyography (EMG) at needle electrodes demonstrates abnormal spontaneous potentials and decreased recruitment, indicating early axonal damage.\n   * Antibody detection: serum anti-Langfei junction antibody was positive, especially serum anti-NF155, anti-CNTN1, anti-Casp1 and anti-NF140\u002F186 antibody.\n   * Cerebrospinal fluid (CSF) analysis: Protein-cell dissociation is observed, with CSF protein levels typically showing significant elevation.\n\n1.3.6. This study adheres to the diagnostic criteria of the 2024 China Expert Consensus on the Diagnosis and Treatment of Refractory Systemic Myasthenia Gravis\n\n1. Basic conditions\n\n   ① Meet the diagnostic criteria in the China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 edition).\n\n   ② The patient's Myasthenia Gravis Activities of Daily Living (MG-ADL) score was ≥6, and the ocular muscle score was less than 50% of the total score.\n2. Diagnostic criteria:\n\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents (including both corticosteroids and non-corticosteroid immunosuppressants), the post-intervention status (PIS) remains unchanged or worsens.\n   * After adequate doses and duration of at least two conventional immunotherapeutic drugs, the PIS showed improvement, but the MG-ADL score remained ≥6 points for at least six months.\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents, the PIS was remitted or improved, but during the regular tapering of immunotherapy, disease symptoms worsened ≥2 times per year (MG-ADL score ≥6).\n   * Patients who, after a crisis, received multiple immunotherapies including intravenous immunoglobulin (IVIG), plasma exchange, and high-dose intravenous methylprednisolone (IVMP), along with active infection control, still remained unable to wean off mechanical ventilation for more than 14 days due to MG-induced respiratory muscle weakness.\n\nDiagnostic criteria: meeting all the above basic conditions plus 1 of the 4 diagnostic conditions.\n\n1.3.7. This study adheres to the 2017 diagnostic criteria for idiopathic inflammatory myopathy (IIM) established by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), following the EULAR\u002FACR classification system. Patients with a probability score ≥55% in the table below are considered suspected IIM cases. Suspected IIM patients can be diagnosed with dermatomyositis in adults if they meet the following criteria: ① Age ≥18 years at first onset of IIM-related symptoms; ② Presence of Heliotrope sign, Gottron papules, or Gottron sign; ③ Objective proximal symmetrical arm weakness (confirmed by manual muscle strength testing or other strength assessment methods), typically progressive, or objective proximal symmetrical leg weakness, typically progressive, or more pronounced neck flexor weakness than neck extensor weakness, or more pronounced proximal leg weakness than distal leg weakness. If patients meet criteria ① and ② but not ③, they may be diagnosed with non-myopathic dermatomyositis. Compared to previous standards, this criterion demonstrates higher sensitivity and specificity. In this standard, patients with typical clinical manifestations (such as characteristic rashes) do not require further tests (e.g., muscle biopsy), while some patients without typical rashes may be missed.\n\nExclusion Criteria:\n\n* This is an observational study with no specific exclusion criteria.\n* The investigators identified other unexplained factors that may have disqualified participants from enrollment.","80 Years",{"count":319,"type":21},1550,"10 Years","Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular junctions. This study examines clinically significant NADs such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein G antibody-related diseases (MOGAD), autoimmune encephalitis (AE), immune-mediated peripheral neuropathy (PN), myasthenia gravis (MG), and idiopathic inflammatory myopathy (IIM). While sharing the core pathogenesis of autoimmune response, these diseases exhibit significant heterogeneity in epidemiological patterns, clinical manifestations, therapeutic approaches, and disease progression. This heterogeneity stems from multiple factors: (1) Differences in immune targets: MS primarily involves T-cell-mediated myelin attack, NMOSD is mainly driven by astrocyte damage caused by anti-AQP4 antibodies, MOGAD results from myelin surface loss mediated by antibodies against myelin oligodendrocyte glycoprotein immunoglobulin G, while AE involves synaptic dysfunction due to antibodies against neuronal surface proteins (e.g., anti-NMDA-R antibodies); (2) Genetic-environmental interactions: MS is more prevalent in European and American populations, whereas NMOSD is more aggressive in Asian populations; (3) Variability in treatment response: Some diseases respond well to immunomodulatory therapy, but most still face challenges such as high relapse rates, progressive disability accumulation, and irreversible neurological damage.\n\nWhile randomized controlled trials (RCTs) provide high-quality core evidence for drug registration, their strict inclusion\u002Fexclusion criteria, relatively homogeneous patient populations, and short-term observation designs often fail to fully capture the complex disease progression and treatment response patterns in real-world clinical settings. Additionally, long-term RCTs are frequently constrained by economic factors and sustainability challenges. Therefore, conducting comprehensive real-world observational studies (RWS) on NADs-integrating multi-disease cohorts, long-term follow-up data, and diverse clinical practices-holds significant scientific and clinical value for optimizing treatment strategies and improving long-term patient outcomes.",[323,324,325,326,327,328,329,330,28],"Multiple Sclerosis","NMO Spectrum Disorder","Autoimmune Encephalitis","Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease","Autoimmune Nodopathy","Acute Inflammatory Demyelinating Polyradiculoneuropathy","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Myasthenia Gravis","2026-01-17",{"date":333,"type":38},"2026-01-21",{"date":335,"type":21},"2026-03-01",{"date":337,"type":21},"2037-03-01",{"name":339,"class":45},"Tongji Hospital",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":346,"maxAge":55,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":264},"100552959","early-phase-1-efficacy-and-safety-of-pozelimab-and-cemdisiran-combination-therapy-in-patients-with-sporadic-inclusion-body-myositis-100552959","NCT06479863","Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis","Inclusion Criteria:\n\n* 1\\. Age ≥45 years to 75 years of age 2. Diagnosed with sIBM based on the ENMC IBM Research Diagnostic Criteria 3. Willing and able to comply with clinic visits and study-related procedures. 4. Provide informed consent signed by the study patient or legally acceptable representative.\n\n  5\\. Able to understand and complete study-related questionnaires. 6. Able to ambulate at least 20 ft\u002F6 meters with or without assistive device Once arising from the chair, the participant may use any walking device, i.e. walker\u002Fframe, cane, crutches, or braces. They cannot be supported by another person and cannot use furniture or walls for support.\n\n  7\\. If female, the subject must be: (a) surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. or (b) of childbearing potential and using a birth control method, such as:\n\n  •Combined (estrogen and progestogen-containing) hormonal. contraception associated with inhibition of ovulation:\n\n  o Oral\n  * Intravaginal\n  * Transdermal\n\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation:\n  * Oral\n  * Injectable\n  * Implantable\n\n    • Intrauterine device\n\n    • Intrauterine hormone-releasing system\n\n    • Bilateral tubal occlusion\n    * Vasectomized partner\n    * Sexual abstinence or of non-childbearing potential (i.e., no menses for ≥12 consecutive months without any other underlying medical cause) The subject must agree to continue using her selected method of birth control with her sexual partner during the study and for 120 days after study completion.\n\n      8\\. If male, the subject must have had a vasectomy or must use a reliable method of birth control with their partner or maintain total abstinence from sexual intercourse. The subject must agree to continue using his selected method of birth control with his sexual partner during the study and for 120 days after the study completion.\n\nExclusion Criteria:\n\n* 1\\. Other neurological conditions (e.g., hemiplegia post-stroke, Parkinson's Disease) or musculoskeletal conditions (e.g., severe osteoarthritis) causing mobility impairment.\n\n  2\\. Any known active malignancy 3. Significant illness or history of significant illness that, in the investigator's opinion, may adversely affect the patient's participation in this study.\n\n  4\\. Any previous treatment with a complement inhibitor 5. History of meningococcal disease 6. No documented meningococcal and pneumococcal vaccination within 5 years prior to screening visit unless vaccination will be administered during the screening period and prior to initiation of study treatment.\n\n  7\\. Known contraindication to meningococcal (group ACWY conjugate and group B vaccines) and pneumococcal vaccines.\n\n  8\\. Subject unwilling to receive meningococcal and pneumococcal vaccinations. 9. Patients with screening serum ALT levels \\>3×ULN and\u002For total bilirubin \\>2×ULN (unless bilirubin elevation is due to suspected Gilbert's syndrome).\n\n  10\\. Active or recent systemic infection within 2 weeks prior to Baseline. 11. Pregnant, planning to become pregnant, or lactating female subjects. 12. Treatment with an experimental drug within 30 days or 5 half-lives of the experimental drug.\n\n  13\\. Participation in another concurrent interventional clinical trial. 14. Subjects with functional and anatomic asplenia 15. Subjects with positive tests for hepatitis B, hepatitis C, or HIV at screening 16. Presence of active or latent tuberculosis 17. Presence of any other form of myositis or myopathy or myositis overlap with other autoimmune diseases 18. Presence of other autoimmune or autoinflammatory diseases","45 Years",{"count":348,"type":21},10,[24],"To evaluate the efficacy of Pozelimab\u002FCemdisiran combination therapy in patients with sIBM",[352,28],"Sporadic Inclusion Body Myositis (sIBM)","2026-01-15",{"date":355,"type":38},"2026-01-16",{"date":357,"type":38},"2024-08-08",{"date":359,"type":21},"2027-08-30",{"name":361,"class":45},"Austin Neuromuscular Center",{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":46},"100594649","phase-1-safety-and-efficacy-of-baff-r-cart-for-refractory-neuroimmune-diseases-100594649","NCT07022197","Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases","Inclusion Criteria:\n\n1\\. Assessed by the investigator as having a refractory neuroimmune disease;\n\nRefractory neuroimmune diseases were defined as:\n\n1. Poor symptom control on at least three immunosuppressive agents for more than one year;\n2. Clinical evidence of at least two relapses within 12 months or three relapses within 24 months and one relapse within 12 months prior to screening.\n\n2\\. Male study participants must agree to use contraception during the treatment period for 1 year after receiving study treatment, and sperm donation is prohibited throughout the study period;\n\n3\\. In the case of females with childbearing potential, need to agree to use contraception during the treatment period and for at least 1 year after receiving study treatment. Participants must have a negative serum pregnancy test result at screening and a confirmed negative urine pregnancy test result prior to first CART treatment.\n\nExclusion Criteria:\n\n1. Any medical or psychiatric condition that, in the opinion of the investigator, may jeopardize the study participant or affect the study participant's ability to participate in this study;\n2. A history of drug or alcohol abuse within the 12 months prior to baseline, or any condition that in the opinion of the investigator is associated with poor adherence;\n3. Women who are breastfeeding or pregnant, or who plan to become pregnant at any time during the 12-month time period following treatment with CART, or a history of spontaneous or induced abortion within 4 weeks prior to screening;\n4. Study participants with a clinically relevant active infection (e.g., sepsis, pneumonia, or abscess) or serious infection (resulting in hospitalization or requiring antibiotic therapy) within 4 weeks prior to baseline;\n5. The study participant has received a live attenuated vaccination within 8 weeks prior to baseline; or is scheduled to receive a live vaccination (including COVID-19 vaccine) within 8 weeks after treatment;\n6. Study participants who have received prior treatment with rituximab within 6 months prior to baseline;\n7. Study participants had received tolizumab, eculizumab within 3 months prior to baseline;\n8. Study participants who have received intravenous human immunoglobulin, plasma exchange, undergone immunotherapy within 4 weeks prior to baseline;\n9. Known concomitant serious underlying diseases, such as hepatic and renal impairment, hematologic disorders, previous severe cardiovascular disease, severe hypertension, diabetes mellitus, poor control of blood pressure and blood glucose;\n10. Comorbid mental illness, suicidal ideation (affirmative answer (yes) to question 4 or question 5 of the Colombian Suicide Severity Rating Scale (C-SSRS) indicating a suicide attempt within the last 6 months);\n11. Any of the following laboratory abnormalities during the screening period (a repeat measurement may be taken during the screening period prior to randomization to confirm results); (1) Elevated liver enzymes: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times the upper limit of normal (ULN); (2) Total bilirubin \\> 1.5 times the ULN; (3) Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m2; (4) CD19 + B cell count \\\u003C40 cells\u002FµL;\n12. Presence of a history of tuberculosis infection, high risk of acquired tuberculosis infection;\n13. known immunodeficiency diseases, including human immunodeficiency virus (HIV) infection;\n14. Viral hepatitis B surface antigen (HBsAg) positivity during the screening period;\n15. Receiving blood transfusion therapy 4 weeks prior to baseline or during the screening period;\n16. Any other condition that the investigator deems inappropriate for participation in the study.","60 Years",{"count":57,"type":21},[59,182],"This study is a phase Ib\u002FIIa dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous T cells expressing chimeric antigen receptor (CAR)-targeted B-cell activating factor receptor (BAFFR) in refractory neuroimmune diseases. The study design is divided into two parts, the first of which will be given to each patient at 3 incremental dose levels to establish the maximum tolerated dose (MTD). Each disease is expected to enroll 12 patients who meet the inclusion criteria. In the second part, 15 patients per disease will be recruited to further characterize the efficacy of the MTD.",[329,324,330,28],"2025-06-06",{"date":375,"type":38},"2025-06-15",{"date":377,"type":38},"2025-04-10",{"date":379,"type":21},"2027-12-30",{"name":381,"class":45},"Tianjin Medical University General Hospital",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":254,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":46},"100591868","early-phase-1-clinical-study-on-the-targeted-cd19-universal-car-t-cell-injection-rd06-04-for-the-treatment-of-iim-and-aav-100591868","NCT06986018","Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of IIM and AAV","Clinical Study on the Safety, Efficacy, and Pharmacokinetics of a Universal CD19-Targeted CAR-T Cell Injection (RD06-04) in the Treatment of Patients With Refractory Inflammatory Myopathy and ANCA-Associated Vasculitis","General Inclusion Criteria:\n\n1. The subject voluntarily participates in this trial and has signed the informed consent form.\n2. Age ≥18 years and ≤70 years, regardless of gender.\n3. Organ Function and Laboratory Tests:\n\n   1. Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except for Gilbert syndrome).\n   2. Renal Function: Creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood Routine: Neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60 g\u002FL, platelet count ≥50×10\\^9\u002FL, lymphocyte count \\>0.3×10\\^9\u002FL.\n   4. Coagulation Function: International normalized ratio (INR) ≤1.5×ULN, or prothrombin time (PT) ≤1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest while breathing room air.\n   6. Echocardiography shows left ventricular ejection fraction (LVEF) ≥50%.\n4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test result during screening.\n5. Females of childbearing potential must agree to use highly effective contraception from at least 28 days before the start of lymphodepletion until 12 months after the infusion of RD06-04. Males of reproductive potential must agree to use an effective barrier method of contraception from the start of lymphodepletion until 12 months after the infusion of RD06-04 and must not donate semen or sperm during the entire trial period.\n\nFor IIM participants:\n\n1\\. Diagnosed with IIM (including probable or definite diagnosis, i.e., a probability of ≥55%) according to the 2017 ACR\u002FEULAR classification criteria. Currently, the ENMC considers that the subtypes of IIM mainly include dermatomyositis (DM), antisynthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).\n\nFor AAV participants:\n\n1\\. Meets the diagnostic criteria for ANCA-associated vasculitis as established by the 2022 ACR\u002FEULAR, including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), and eosinophilic granulomatosis with polyangiitis (EGPA).\n\nExclusion Criteria:\n\n1. As determined by the investigator, the primary diagnosis is a rheumatic autoimmune disease other than the disease under study, which the investigator believes may confound the efficacy evaluation of the study disease.\n2. Clinically significant central nervous system disease or pathological changes not caused by the non-study disease within 12 months prior to screening.\n3. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (such as kidney, lung, heart, liver) or plans for such transplantation in the future.\n4. For IIM patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n5. History of, or current significant cardiovascular dysfunction.\n6. History of malignancy within 5 years prior to signing the ICF.\n7. Pregnant or breastfeeding women.\n8. History of recurrent infections requiring hospitalization and intravenous antibiotics (e.g., three or more episodes of the same type of infection within the past year).\n9. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n10. History of drug or alcohol abuse within 1 year prior to screening.\n11. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":390,"type":21},12,[24],"This is an open-label, investigator-initiated clinical trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with refractory IIM and AAV. The study plans to enroll a total of 12 participants, with 6 cases each for IIM and AAV. Enrollment for both diseases will proceed in parallel. The dose will be 6×10\\^6 CAR+T cells\u002Fkg (±30%), and patients will receive a single infusion of RD06-04.",[28,394],"ANCA-Associated Vasculitis",[396],"CD19-Targeted Universal CAR-T","2025-05-15",{"date":399,"type":38},"2025-05-22",{"date":401,"type":21},"2025-06-14",{"date":403,"type":21},"2026-12-31",{"name":405,"class":45},"Peking University People's Hospital",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":254,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":46},"100590709","early-phase-1-early-clinical-study-of-utaa91-injection-for-the-treatment-of-relapsedrefractory-autoimmune-diseases-100590709","NCT06970951","Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed\u002FRefractory (R\u002FR) Autoimmune Diseases","Inclusion Criteria\n\n1. Age ≥ 18 years (including the cut - off value), with no restrictions on gender.\n2. Expected survival time ≥ 3 months.\n3. Subjects with relapsed\u002Frefractory autoimmune diseases who have failed standard treatment or lack effective treatment options, including but not limited to rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus, idiopathic inflammatory myopathies, Sjögren's syndrome, connective tissue disease - related interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.\n4. Liver and kidney functions and cardiopulmonary functions meet the requirements.\n5. No severe mental disorders.\n6. Able to understand this trial and have signed the informed consent form.\n\nExclusion Criteria\n\n1. Malignant tumors other than relapsed\u002Frefractory autoimmune diseases (R\u002FR AID) within 5 years before screening.\n2. Subjects with positive virus and\u002For syphilis tests.\n3. Presence of severe heart disease or unstable systemic diseases.\n\n5\\. Presence of active or uncontrollable infections requiring systemic treatment.\n\n6\\. Pregnant or breastfeeding women, as well as female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.\n\n7\\. Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.",{"count":20,"type":21},[24],"This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with relapsed\u002Frefractory autoimmune inflammatory diseases (AID).",[27,63,417,28,62],"Dry Syndrome","2025-05-06",{"date":420,"type":38},"2025-05-14",{"date":422,"type":21},"2025-05-18",{"date":424,"type":21},"2027-04-30",{"name":426,"class":76},"PersonGen BioTherapeutics (Suzhou) Co., Ltd.",{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":217,"sex":435,"minAge":436,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":439,"conditions":440,"keywords":452,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":46},"100569575","aylo---autoimmunity-and-loss-of-y-100569575","NCT06696027","AYLo - AutoimmunitY and Loss of y","Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases","AYLo","Inclusion Criteria:\n\n* Male\n* \\> 50 years\n* Diagnosis of arthritis (RA, PsA), collagen diseases (SLE, systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis (eGPA, GPA, MPA, IgG4-related disease, GCA, PMR), sarcoidosis, COPD, ILD or asthma bronchiale confirmed by the treating physician.\n\nExclusion Criteria:\n\n* Female\n* \\\u003C 50 years\n\nInclusion Criteria (Healthy controls):\n\n* Male\n* \\> 50 years\n\nExclusion Criteria (Healthy controls):\n\n* Female\n* \\\u003C 50 years\n* autoimmune, rheumatological diease\n* pulmonary precondition","MALE","50 Years",{"count":438,"type":21},500,"The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies.\n\nThrough the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation.\n\nA further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data.\n\nAdditionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders.\n\nBy integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.",[441,442,443,28,444,445,446,447,151,448,449,450,451],"Giant Cell Arteritis (GCA)","Polymyalgia Rheumatica (PMR)","ANCA Associated Vasculitis (AAV)","IgG4-Related Diseases","Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Connective Tissue Disease","Interstitial Lung Disease Due to Systemic Disease (Disorder)","Interstitial Lung Disease (ILD)","Asthma Bronchiale","COPD",[226,453,454,455,456,146,28,444,63,457,447,151,458],"Vasculitis","Large Vessel Vasculitis","Giant Cell Arteritis","Polymyalgia Rheumatica","Psoriatic Arthritis","Interstitial Lung Disease","2025-04-07",{"date":377,"type":38},{"date":462,"type":38},"2024-11-15",{"date":464,"type":21},"2026-07",{"name":466,"class":45},"University of Bonn",{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":474,"conditions":475,"keywords":476,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":487,"locationsCount":46},"100292848","optimizing-treatment-on-idiopathic-inflammatory-myopathies-100292848","NCT03092180","Optimizing Treatment on Idiopathic Inflammatory Myopathies","Inclusion Criteria:\n\n* Idiopathic inflammatory myopathies\n\nExclusion Criteria:\n\n* Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies",{"count":121,"type":21},"As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and\u002For human intravenous immunoglobulin, or only methyprednisolone at disease onset.\n\nThis scheme is an internal routine protocol of our Service.",[28],[100,477,478,99,101,479,480],"Immunomodulation","Immunosuppressive agents","Necrotizing myopathies","Antisynthetase syndrome","2024-12-04",{"date":483,"type":38},"2024-12-05",{"date":485,"type":4},"2005-01",{"date":481,"type":21},{"name":488,"class":45},"University of Sao Paulo",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":217,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":498,"conditions":499,"keywords":505,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":46},"100554663","biomarkers-in-autoimmune-disease-of-nervous-system-100554663","NCT06502015","Biomarkers in Autoimmune Disease of Nervous System","Biomarkers of Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Clinical diagnosis with autoinflammatory diseases of the nervous system, including: Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy(IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), ect al.\n* sex and age-matched healthy individuals\n\nExclusion Criteria:\n\n* Known history of primary immunodeficiency (innate or acquired).\n* Patients with severe central nervous system, pulmonary, or other systemic infections.\n* Patients with secondary central nervous system demyelinating lesions, such as those caused by vasculitis, systemic lupus erythematosus, and Sjögren's syndrome.\n* Patients with vascular (including hemorrhagic and ischemic), hereditary metabolic, neoplastic, or toxic diseases.\n* Pregnant or lactating women.",{"count":497,"type":21},50000,"Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves. These diseases exhibit high heterogeneity, diverse clinical presentations, and are challenging to diagnose and manage due to a lack of effective treatments. In this study, the investigators will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy (IIM), and multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Through this study, the investigators aim to discover biomarkers with high sensitivity, specificity, and stability, which can support early diagnosis, disease monitoring, and personalized treatment for neurological autoimmune diseases, thereby improving the quality of life and prognosis for patients.",[500,501,323,502,503,325,504,330,329,28,226],"Autoimmune Diseases of the Nervous System","Neuromyelitis Optica Spectrum Disorder","Guillain-Barre Syndrome","Acute Disseminated Encephalomyelitis","Stiff-Person Syndrome",[506,500,507],"Biomarker","Immune cell","2024-11-17",{"date":510,"type":38},"2024-11-20",{"date":512,"type":38},"2024-07-31",{"date":514,"type":21},"2027-07",{"name":339,"class":45},{"id":517,"slug":518,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":531,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":46},"100405605","early-phase-1-safety-and-efficacy-of-ct103a-cells-for-relapsedrefractory-antibody-associated-inflammatory-diseases-of-the-nervous-system-100405605","NCT04561557","Safety and Efficacy of CT103A Cells for Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","CARTinNS","Inclusion Criteria:\n\n1. Male or female subjects aged 18-75 years (including 18 and 75 years);\n2. Subjects with Relapsing\u002Frefractory Antibody-mediated inflammatory diseases of the nervous system without effective treatment, including:\n\n   1. Subjects must be diagnosed as AQP4-IgG-positive NMOSD defined by 2015 criteria of IPND NMOSD and meet the following requirements: i. At least one kind of immunosuppressant has been used for more than one year with poorly-controlled symptoms; ii. Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.\n   2. Subjects with MG with positive abnormal antibody, MG-ADL total score ≥ 6 points, MGFA classification II-IV defined by 2020 MGFA diagnostic criteria and meet the following requirement: i. At least one kind of immunosuppressant for standardized treatment for more than 1 year, and have one of the following poor control conditions: 1) continuous inability to affect daily life; 2) Exacerbation of MG symptoms and\u002For crisis attacks still occur despite standard treatment; 3) Inability to tolerate immunosuppressive therapy ii. Requires plasma exchange or maintenance therapy with IV gamma globulin\n   3. Subjects with CIDP with positive abnormal antibodies, INCAT disability scale with total score of 2-9 defined by 2021 EAN\u002FPNS diagnostic criteria and meet the following requirement: i. Standardized use of at least one first-line therapy for more than 3 months (cortisol hormone therapy, gamma globulin or plasma exchange therapy) with poorly-controlled symptoms. ii. Inability to tolerate cortisol hormones, gamma globulin, and plasmapheresis because of side effects or other conditions\n   4. Subjects were diagnosed with IIM defined by 2017 European League against Rheumatism\u002FAmerican Rheumatology (EULAR\u002FACR) conference Class criteria; At least one kind of cardiac enzymes (CK, AST, ALT, ALD, LDH) ≥1.5×ULN during the screening period, or Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) ≥6, or at least one other sign of active disease within the last 6 months: MRI, EMG, or muscle biopsy; positive serological tests for myositis-specific antibodies (MSA) or myositis-associated autoantibodies (MAA), or antinuclear antibody (ANA). and meet one of the following requirements:\n\n   i. After at least 1 month of corticosteroid therapy and standardized use of at least one immunosuppressant\u002Fmodulator (eg, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, Cyclophosphamide, leflunomide, intravenous gamma globulin, etc.) for more than 3 months with poorly-controlled symptoms.\n\n   ii. ii. Inability to tolerate the above traditional regimens due to side effects or other conditions;\n\n   e. Subjects were diagnosed with PMS (including PPMS and SPMS) or RMS according to the 2017 revision of the McDonald diagnostic criteria；EDSS score between 2 to 7 points inclusive, at screening. Subjects with RMS should meet one of the following requirements after standard therapy: i. at least two relapses in the last two years before screening. ii. at least one relapse in the last one year before screening. iii. positive Gd-enhancing MRI in the last one year before screening.\n\n   f. Subjects were diagnosed with POEMS syndrome according to the 2021 revised IMWG diagnostic criteria and meet all of the following requirements: i. bone marrow involvement; ii. no response to traditional regimens treatment including corticosteroid, chemotherapy, protease inhibitor or inability to tolerate the above traditional regimens; iii. Have measurable lesions (refer to the 2021 revised IMWG standard) iv. VEGF \\> 2 ULN; v. ECOG score ≥1; vi. ONLS score ≥1.\n\n   g. Subjects were diagnosed with autoimmune encephalitis according to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis and meet all of the following requirements: i. at least one pathogenic antibody positive; ii. previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance; iii. onset of autoimmune encephalitis within 3 months prior to screening; iv. mRS Score ≥2 or CASE score ≥4.\n\n   h. Subjects were diagnosed with MOGAD according to the 2023 International MOGAD Diagnostic criteria and meet all of the following requirements: i. a documented positive serum MOG Ab test using a cell-based assay (CBA); ii mRS Score ≥2; iii previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance.\n3. All acute toxic reactions resolved to baseline or ≤ grade 1 assessed using NCI-CTCAE v5.0 except the ones adjudicated by the investigator to pose no risks on subjects.\n4. Enrolled subjects must have satisfactory organ function and laboratory findings as defined by the following:i. Blood tests: absolute neutrophil count ≥ 2×109\u002FL (or normal lower limit set by the central lab of the institution), platelets ≥ 100 × 109\u002FL, and hemoglobin ≥ 100 g\u002FL; ii. Liver function: total serum bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤ 1.5x the institutional normal upper limit (ULN); iii. Kidney function: CrCl ≥ 60 ml\u002Fmin\u002F1.73m2 (according to the following Cockcroft-Gault formula); iv. Electrolytes: blood potassium ≥ 3.0 mmol\u002FL; blood calcium ≥ 2.0 mmol\u002FL, blood magnesium ≥ 0.5 mmol\u002FL; v. Coagulation function: fibrinogen ≥ 1.0 g\u002FL; APTT ≤ ULN + 10s; PT ≤ ULN + 3s.\n5. Blood oxygen saturation \\> 91% in resting state.\n6. Echocardiography suggests LVEF≥ 50%.\n7. Expected life expectancy ≥ 12 weeks as assessed by the investigator.\n8. After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year after CT103A cells infusion (excluding contraception safety periods).\n9. Subjects must provide written informed consent before the study begin.\n\nExclusion Criteria:\n\n1. Patients do not have adequate mononuclear cells without mobilization for CAR-T cell manufacturing.\n2. History of autoimmune hemolytic disease.\n3. History of solid organ transplantation.\n4. Patients were treated with alemtuzumab within 6 months prior to apheresis. Patients were treated with fludarabine or cladribine within 3 months prior to apheresis.\n5. Patients with Papovaviruses infection.\n6. Patients have been diagnosed with malignancies in the last 2 years prior to screening except for non-melanoma skin cancer, stage I cancers with complete resection and low risk of relapse, localized prostate cancer post-treatments, biopsy-confirmed in situ cervical cancer, or squamous epithelial lesion by PAP smear.\n7. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.\n8. MG crisis was not effectively controlled within 2 weeks before enrollment.\n9. Known history of primary immunodeficiency (innate or acquired).\n10. Patients with severe impaired cardiac function, including but not limited to the following: unstable angina, myocardial infarction (within 6 months before enrollment), congestive heart failure (≥Grade III by NYHA), severe ventricular arrhythmia.\n11. Cerebrovascular accidents, including transient ischemic attack or stroke history, occurred within 6 months before enrollment.\n12. Major operation or surgical treatment caused by any reason within 4 weeks before enrollment.\n13. Any serious and\u002For uncontrolled comorbidities which may interfere with the evaluation during the study in the opinion of the investigator\n14. Previous treatments: History of thymectomy within 12 months prior to CT103A infusion;\n15. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.\n16. Prone to allergies or history of serious allergy.\n17. Pregnant or lactating women.\n18. Patients with other conditions adjudicated by the investigator as unsuitable for enrollment.\n\nCriteria for lymphodepletion and CAR-T cells infusion:\n\nBefore lymphocyte depletion and CAR-T cells infusion, patients are evaluated and those meeting the following criteria cannot be included:\n\n1. Blood tests: neutrophil count \\\u003C 2 × 109\u002FL, platelet count \\\u003C 50 × 10\\^9\u002FL;\n2. Oxygen inhalation is required to maintain blood oxygen saturation ≥ 91%;\n3. Patients have the following conditions, including but not limited to: new arrhythmia cannot be controlled by drugs; hypotension requiring pressor drugs; bacterial, fungal or viral infection requiring intravenous antibiotic treatment; creatinine clearance rate \\\u003C 50 ml\u002Fmin ;\n4. Patients require maintenance support treatment within one week to meet the criteria for lymphodepletion or CAR T cell infusion.\n5. Cell infusion is delayed \\> 7 days after lymphodepletion for any reason;\n6. Patients with other conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.",{"count":525,"type":21},36,[24],"Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed\u002Frefractory antibody-mediated idiopathic inflammatory diseases.",[226,500,501,330,329,28,323,325,529,530],"Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)","POEMS Syndrome",[532,533,534,500],"Adoptive T Cell Therapy","Chimeric antigen receptor","B-cell maturation antigen (BCMA)","2024-10-27",{"date":537,"type":38},"2024-10-30",{"date":539,"type":38},"2020-09-22",{"date":541,"type":21},"2027-05-31",{"name":339,"class":45},{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":561,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":46},"100542995","phase-1-fourth-gen-car-t-cells-targeting-bcmacd19-for-refractory-systemic-lupus-erythematosus-sle-100542995","NCT06350110","Fourth-gen CAR T Cells Targeting BCMA\u002FCD19 for Refractory Systemic Lupus Erythematosus (SLE)","T-cell Infusion Targeting BCMA and CD19 for Refractory\u002FRelapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement","BAH242","Inclusion Criteria:\n\n* 18-90 years old;\n* Total score ≥ 10 on the EULAR\u002FACR 2019 SLE classification criteria.\n* SELENA-SLEDAI≥8.\n* Patients with CD19+ B-cell.\n* Hemoglobin≥85 g\u002FL.\n* WBC≥2.5×10\\^9\u002FL.\n* NEUT≥1×10\\^9\u002FL.\n* BPC≥50×10\\^9\u002FL.\n* AST\u002FALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL\u002Fmin; blood bilirubin ≤2.0 mg\u002Fdl; echocardiography indicates that the ejection fraction is ≥50%.\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis.\n* Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline.\n* Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.\n* Agree to attend follow-up visits as required.\n* Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n\nExclusion Criteria:\n\n* Renal disease: severe lupus nephritis (serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL) within 8 weeks --Prior to leukapheresis, or subjects who need hemodialysis.\n* CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \\[CVA\\], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.\n* Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.\n* Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;\n* Received immunosuppressive therapy within 1 week prior to leukapheresis.\n* Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus.\n* Patients with syphilis infection.\n* The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening.\n* Received live vaccine treatment within 4 weeks prior to screening.\n* Severe allergies or hypersensitivity.\n* Contraindication to cyclophosphamide in combination with fludarabine.\n* Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion.\n* Cannula or drainage tubes other than central venous catheters.\n* Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;\n* Subjects with prior CD19 or BCMA-targeted therapy.\n* Participated in any clinical study within 3 months prior to enrollment.\n* Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.","90 Years",{"count":553,"type":21},75,[59,182],"This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.",[27,557,226,558,559,560,62,28,301],"Lupus Nephritis","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Granulomatous Polyangiitis","Microscopic Polyangiitis",[562],"CAR-T Cell Therapy","2024-10-11",{"date":565,"type":38},"2024-10-15",{"date":567,"type":38},"2024-07-10",{"date":569,"type":21},"2025-12-28",{"name":571,"class":45},"Essen Biotech",{"id":573,"slug":574,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":46},"100540379","phase-1-safety-and-efficacy-study-of-cd19-car-dnt-cells-in-autoimmune-diseases-100540379","NCT06316076","Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases","A Clinical Study for the Safety and Efficacy of CD19-CAR-DNT Cells (RJMty19) in the Treatment of Relapsed or Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Voluntarily sign an ICF and expect to complete the study procedures for follow-up examinations and treatment;\n2. Aged 18 to 75 years (including cut-offs), regardless of gender;\n3. Appropriate organ function, and accordance with the following criteria within 7 days prior to lymphodepleting chemotherapy:\n\n   Coagulation function: a) Fibrinogen ≥1.0 g\u002FL; b) Activated partial thromboplastin time ≤1.5 times the upper limit of normal (ULN); c) Prothrombin time (PT) ≤1.5 times ULN;\n\n   Liver function: a) Glutathione aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); b) Glutamic aminotransferase (ALT) ≤ 3 times ULN; c) Total bilirubin ≤ 1.5 times ULN, unless the subject has documented Gilbert syndrome. Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 1.5 times ULN may be included;\n\n   Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin (see Appendix 2 for Cockcroft-Gault formula);\n\n   Complete blood count: a) Hemoglobin ≥ 80 g\u002FL or hemoglobin maintained at that level following transfusion; b) absolute neutrophil count (ANC) ≥ 1.0×10\\^9\u002FL; c) A platelet count ≥ 30 x 10\\^9\u002FL or a platelet count maintained at that level following a platelet transfusion;\n\n   Cardiopulmonary function: left ventricular ejection fraction (LVEF) ≥45%;\n4. Female patients with of childbearing potential should have a negative pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female patients without childbearing potential (meeting at least 1 of the following criteria) is described below:\n\n   1. Have undergone a hysterectomy or bilateral oophorectomy;\n   2. Medically recognized as ovarian failure;\n   3. Medically recognized as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause);\n5. Meets the criteria of relapsed\u002Frefractory autoimmune diseases in 2022 EULAR\u002FACR.\n\nExclusion Criteria:\n\n1. Individuals with a history of severe drug allergies or allergic constitution;\n2. Active infectious diseases: such as tuberculosis, central nervous system infection, hepatitis, enteritis, etc.;\n3. The following serious diseases: malignant tumor, end-stage renal failure, alveolar hemorrhage requiring mechanical ventilation, acute mononeuritis multiplex, or CNS involvement;\n4. Renal disease: creatinine clearance rate \\\u003C 60mL\u002Fmin and serum creatinine \\> 1.5 times ULN within 1 week before lymphodepleting chemotherapy; Patients required hemodialysis or high-dose glucocorticoid therapy (e.g., prednisone (or equivalent) ≥100mg per day) within 6 months before screening;\n5. Cardiovascular disease: unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction, New York Heart Association class III or IV cardiac dysfunction, or refractory hypertension within 6 months before screening (refractory hypertension was defined as: on the basis of lifestyle modification, patients were treated with adequate and reasonably tolerable doses of ≥3 antihypertensive drugs (including diuretics) for \\> 1 month or with ≥4 antihypertensive drugs for effective blood pressure control) and a history of severe arrhythmia requiring drug treatment;\n6. Other uncontrollable diseases: clinically unstable or not effectively controlled acute\u002Fchronic diseases unrelated to AID (such as acute pneumonia, diabetic ketoacidosis, acute pancreatitis, etc.) that may confound study results or affect investigators' assessment of efficacy\u002Fsafety;\n7. Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titration assay not within the normal reference range, positive hepatitis C virus (HCV) antibody and peripheral blood HCV RNA, positive for human immunodeficiency virus (HIV), or positive for cytomegalovirus (CMV) DNA, or positive syphilis test;\n8. The presence of active or uncontrollable infections requiring systemic treatment (except simple urinary tract infections or upper respiratory tract infections) and currently receiving suppressive therapy for any chronic infection (e.g., tuberculosis, Pneumocystis carinii, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria);\n9. Vaccination with live or attenuated live vaccine within 1 month before screening;\n10. Persons who have previously received an organ transplant or are preparing to receive an organ transplant;\n11. Patients have received CAR-T therapy or other gene-modified cell therapy prior to enrolment;\n12. Received rituximab treatment within 6 months prior to screening; Received belimumab and telitacicept within 30 days prior to initial administration of the investigational drug; JAK inhibitor discontinuation time is less than 5 half-lives;\n13. Patients with a life expectancy of less than 3 months;\n14. Patients have been involved in other clinical studies within 3 months prior to screening;\n15. Patients, in the judgement of the investigator and\u002For clinical criteria, are contraindicated to any study procedure or have other medical conditions that may place them at unacceptable risk.\n\n    \\-",{"count":580,"type":21},48,[59],"To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed\u002Frefractory autoimmune diseases",[27,558,28,62],{"date":585,"type":38},"2024-03-18",{"date":587,"type":38},"2023-10-30",{"date":589,"type":21},"2026-06",{"name":591,"class":45},"RenJi Hospital",{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":598,"targetDuration":600,"studyType":142,"phases":4,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":254,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":4},"100539646","clinical-study-cohort-of-idiopathic-inflammatory-myositis-100539646","NCT06306547","Clinical Study Cohort of Idiopathic Inflammatory Myositis","Inclusion Criteria:Subjects must meet the following criteria for inclusion in this study: meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (IIM) or the 2018 ENMC-DM classification criteria (see above), plus:\n\n1. Age≥ 18 years old and ≤ 75 years old\n2. Meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (IIM), the above score ≥ 5.5 points if there is no muscle biopsy, and 6.7 points ≥ if there is muscle biopsy\n3. Cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form.\n\n   \\-\n\n   Exclusion Criteria:Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:\n\n   a. IIM with other connective tissue diseases; b. Negative myositis antibody test; c. Those who are in the period of acute infection, or have a history of active tuberculosis in the past; d. People with allergies or allergies to multiple drugs; e. Those who have mental illness or other reasons and cannot cooperate with examination, follow-up or treatment; f. Women who are pregnant, or are trying to become pregnant; g. Those who are participating in or have participated in clinical trials within the specified time.\n\n   \\-",{"count":599,"type":21},1000,"3 Years","Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases.",[28],"2024-03-09",{"date":283,"type":38},{"date":606,"type":21},"2024-04-01",{"date":608,"type":21},"2034-04-01",{"name":591,"class":45}]