[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anca-associated-vasculitis-aav\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anca-associated-vasculitis-aav":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,47,80,103,130,160,186,211,238,264,288,312,331,360,385,407,434,454,480,517,535],{"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":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100582821","phase-2-phase-2-study-evaluating-rapcabtagene-autoleucel-in-participants-with-severe-active-gpa-or-mpa-100582821","NCT06868290","Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA","A Phase 2, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Comparator in Participants With Severe Active Granulomatosis With Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)","Key inclusion criteria:\n\n1. Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology\u002F European League Against Rheumatism 2022 (ACR\u002FEULAR 2022) classification criteria\n2. Positive test for ANCA-autoantibodies\n3. GPA and MPA participants with severe active disease\n\nKey exclusion criteria:\n\n1. Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study\n2. Hypersensitivity and\u002For contraindications to any product to be given to the participant as part of the study protocol\n3. Other systemic autoimmune diseases requiring therapy\n4. Any medical conditions that are not related to GPA\u002FMPA that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy\n5. Inadequate organ function","75 Years",{"count":56,"type":21},126,[58],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)",[61],"ANCA Associated Vasculitis (AAV)",[63,64,65,66,67,68],"Chimeric Antigen Receptor-T (CAR-T)","rapcabtagene autoleucel","anti-neutrophil cytoplasmic antibody (ANCA)","ANCA-associated vasculitis\u002Fvasculitides (AAV)","Granulomatosis with Polyangiitis (GPA)","Microscopic Polyangiitis (MPA)","2026-05-19",{"date":71,"type":38},"2026-05-20",{"date":73,"type":38},"2025-03-13",{"date":75,"type":21},"2030-05-24",{"name":77,"class":78},"Novartis Pharmaceuticals","INDUSTRY",35,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100605871","phase-3-bdb-001-phase-iii-trial-in-anca-associated-vasculitis-100605871","NCT07168161","BDB-001 Phase III Trial in ANCA-Associated Vasculitis","A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis","Inclusion Criteria:\n\n1. 18 years old≤Age≤75 years old, male or female;\n2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；\n3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide\u002Fazathioprine or rituximab；\n4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；\n5. Estimated glomerular filtration rate ≥15 mL\u002Fminute\u002F1.73 m\\^2；\n6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；\n\nExclusion Criteria:\n\n1. Active tuberculosis infection;\n2. alveolar hemorrhage requiring pulmonary ventilation support；\n3. History of any malignancy of any organ system within 5 years prior to the first dose, except for basal cell carcinoma of the skin or carcinoma in situ (e.g., cervical or breast carcinoma in situ) that has been completely resected and shows no evidence of local recurrence or metastasis.\n4. Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis,anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis；\n5. HBsAg positive,or HBcAb positive and HBV-DNA positive；\n6. Received CYC within 3 months before the first administration or Received rituximab(RTX) or other B-cell antibody within 12 months before the first administration；\n7. Received glucocorticoid shock therapy within 4 weeks before the first administration；\n8. Received an oral daily dose of a GC of \\> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration；\n9. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration；\n10. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;\n11. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;\n12. Pregnant or lactating.",{"count":88,"type":21},300,[90],"PHASE3","The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab",[61],"2026-04-21",{"date":95,"type":38},"2026-04-23",{"date":97,"type":38},"2025-11-10",{"date":99,"type":21},"2028-02-29",{"name":101,"class":78},"Staidson (Beijing) Biopharmaceuticals Co., Ltd",60,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100599794","phase-1-descartes-08-for-children-adolescents-and-young-adults-with-autoimmune-disorders-100599794","NCT07089121","Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders","Descartes-08 for Children, Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus, ANCA-associated Vasculitis, Juvenile Myasthenia Gravis, and Juvenile Dermatomyositis","Inclusion Criteria:\n\n* At least age 12\n* definitive diagnosis of childhood-onset systemic lupus erythematous, juvenile Myasthenie gravis, juvenile dermatomyositis and AAV\n* Signs and symptoms of moderate disease\n* History of systemic treatment\n* Parent\u002FGuardian\u002FPatient must be able to give written informed consent\n\nExclusion Criteria:\n\n* Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient;\n* Abnormal PT\u002FINR or PTT increased \\> 1.5-fold or patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus anticoagulant; or in patients who have been on stable doses of anticoagulation therapy for more than 6 months of VTE diagnosis; or in patients on stable doses of anticoagulation therapy for at least 8 weeks of atrial fibrillation diagnosis; these conditions will not be exclusionary unless, in the investigator's opinion, they make participation in the study unsafe);\n* ANC \\\u003C 1000 cells\u002Fmicroliter ;\n* Hemoglobin \\\u003C 8.0 g\u002FdL ;\n* Platelets \\\u003C 50,000\u002Fmm3 (NOTE: platelet transfusions are permissible);\n* ALT and\u002For AST with GGT ≥ 3× upper limit of normal\n* Creatine Clearance less than 30mL\u002Fmin \u002F1.73 m2;\n* History of primary immunodeficiency, organ, or allogeneic bone marrow transplant;\n* Patients must be seronegative for hepatitis B surface antigen;\n* Patients must be seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patients must be tested for the presence of viremia by RT-PCR and must be HCV RNA negative;\n* History of positive HIV or positive HIV at screening;\n* Active tuberculosis or positive QuantiFERON test at screening;\n* Any other laboratory abnormality that, in the opinion of the investigator, may jeopardize the subject's ability to participate in the study; 23. Any active significant cardiac or pulmonary disease not related to the primary indication as determined by principal investigator and medical monitor Note: Patients with asthma and COPD controlled with inhaled medications are allowed; 24. Any arterial or venous thromboembolic events in the past 3 months; 25. History of malignancy that required treatment in the past 3 years except for successfully-treated squamous cell and\u002For basal cell carcinoma of the skin and\u002For breast or colon cancer that is surgically removed and did not require adjuvant chemotherapy or radiotherapy; 26. Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer); 27. Receipt of a live vaccination within 4 weeks prior to baseline (Day 1) or intent to receive live vaccination during the study (Note: mRNA-based vaccines such as those against SARS-CoV-2 are not considered live; likewise, the Janssen Covid-19 vaccine is not live); 28. History of significant recurrent infections or any active infection that may interfere with the patient's participation in the opinion of the investigator; 29. Any known psychiatric illness that may interfere with the patient's participation in the study in the opinion of the investigator.","12 Years",{"count":112,"type":21},50,[114,58],"PHASE1","Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis",[117,30,118,119],"Childhood-onset Systemic Lupus Erythematous","Juvenile Myasthenia Gravis","Juvenile Dermatomyositis","2026-04-07",{"date":122,"type":38},"2026-04-08",{"date":124,"type":38},"2026-01-14",{"date":126,"type":21},"2028-12",{"name":128,"class":78},"Cartesian Therapeutics",2,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":46},"100627685","phase-4-comparison-of-a-strategy-based-on-clinico-biological-monitoring-versus-pre-emptive-rituximab-treatment-in-cases-of-anca-reappearance-in-granulomatosis-with-polyangiitis-and-microscopic-polyangiitis-100627685","NCT07451847","Comparison of a Strategy Based on Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment in Cases of ANCA Reappearance in Granulomatosis With Polyangiitis and Microscopic Polyangiitis.","Comparison of Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment for ANCA Repositivation in Granulomatosis With Polyangiitis and Microscopic Polyangiitis: a Prospective, Multicenter, Randomized Controlled Study.","PREP-ANCA","Inclusion Criteria:\n\n* Adult patients aged ≥ 18 years\n* Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the 2022 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria\n* Maintenance treatment with rituximab for at least 18 months, administered as follows: a 500 mg infusion on day 1 (with an optional repeat dose on day 15), followed by 500 mg infusions every 6 months for a total of 4 to 5 doses\n* Patient in complete remission, defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 at the time of randomization\n* ANCA repositivity (confirmed by antigen-specific testing) within the 3 months prior to randomization\n* Ability to provide written informed consent prior to participation\n* Affiliation to a national health insurance or social security scheme\n\nExclusion Criteria:\n\n* Diagnosis of any vasculitis other than GPA or MPA\n* Active disease relapse, defined as BVAS \\> 0\n* Acute active infection requiring hospitalization or intravenous anti-infective therapy within 4 weeks prior to screening, or oral anti-infective treatment within 2 weeks prior to screening\n* History of deep tissue infections (e.g., fasciitis, abscess, osteomyelitis, septic arthritis) within 12 months prior to inclusion\n* History of severe, chronic, or recurrent infections, or any underlying condition predisposing the patient to serious infections\n* Administration of a live vaccine within 4 weeks prior to study inclusion\n* Active malignancy or history of hematologic malignancy within the past 5 years, except for localized prostate cancer or basal cell carcinoma of the skin\n* Presence of systemic diseases for which the study treatments may have unpredictable or inappropriate consequences\n* History of severe allergic or anaphylactic reactions, or known hypersensitivity to humanized or murine monoclonal antibodies and\u002For corticosteroids\n* Known hypersensitivity to any monoclonal antibody or biologic agent\n* Patients previously deemed non-responders or failures to rituximab therapy\n* Suspicion of poor adherence to treatment or anticipated inability or refusal to comply with the required follow-up visits and procedures\n* Inability or refusal to provide written informed consent Pregnant or breastfeeding women. Women of childbearing potential must use effective contraception during the study and for 6 months after the last infusion. Breastfeeding is contraindicated during treatment and for 6 months following the final rituximab dose.",{"count":139,"type":21},70,[141],"PHASE4","The PREP-ANCA study seeks to establish a more personalized treatment strategy for ANCA-associated vasculitides by assessing the efficacy of pre-emptive rituximab administration upon ANCA repositivity in preventing relapses in granulomatosis with polyangiitis and microscopic polyangiitis.",[61,144,68],"Polyangiitis (GPA)",[146,147,148,149],"ANCA","Granulomatosis with polyangiitis","Microscopic polyangiitis","Rituximab","NOT_YET_RECRUITING","2026-03-02",{"date":153,"type":38},"2026-03-05",{"date":155,"type":21},"2026-02",{"date":157,"type":21},"2030-02",{"name":159,"class":45},"Assistance Publique - Hôpitaux de Paris",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":167,"maxAge":17,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":46},"100626699","phase-1-yts109-in-pediatric-relapsedrefractory-autoimmune-diseases-100626699","NCT07439029","YTS109 in Pediatric Relapsed\u002FRefractory Autoimmune Diseases","An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Children With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n\\-\n\n1. Age 5 to \\\u003C18 years at screening; sex not restricted.\n2. CD19 positivity: Presence of CD19-positive B cells in peripheral blood, confirmed by flow cytometry.\n3. Adequate major organ function, meeting all of the following criteria:\n\n1）Bone marrow function:\n\n1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL (no colony-stimulating factor use within 2 weeks prior to testing; neutropenia attributable to the underlying disease may be allowed);\n2. Hemoglobin ≥ 60 g\u002FL. 2）Hepatic function: ALT ≤ 3 × ULN (exceptions allowed for elevations attributable to the underlying disease); AST ≤ 3 × ULN (exceptions allowed for elevations attributable to the underlying disease); Total bilirubin (TBIL) ≤ 1.5 × ULN (exceptions allowed for elevations attributable to the underlying disease).\n\n   3）Renal function: Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m², calculated using the Schwartz formula (exceptions allowed for reduced renal function attributable to the underlying disease).\n\n   4）Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and prothrombin time (PT) ≤ 1.5 × ULN.\n\n   5）Cardiac status: Hemodynamically stable. 4. Females of childbearing potential must be not pregnant and not breastfeeding during screening and throughout the study period.\n\n   5\\. The participant and the legal guardian are willing to participate, provide written informed consent, and can comply with study procedures and follow-up.\n\n   Specific inclusion criteria:\n\n   Recurrent refractory systemic lupus erythematosus\n\n   1\\. Meets the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE).\n\n   2\\. Active disease, defined as either: SELENA-SLEDAI ≥ 6 and at least one BILAG-2004 organ domain score of A (severe activity) or two domains scored B (moderate activity), or a combination thereof; or SELENA-SLEDAI ≥ 8.\n\n   3\\. Relapsed\u002Frefractory or intolerant to conventional therapy, defined as one of the following: Inadequate response after \\>3 months of conventional therapy; or intolerance to treatment-related adverse effects; or Disease flare\u002Frecurrence after achieving remission based on the LLDAS criteria. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n   4\\. If renal involvement is present, a kidney biopsy must have been performed within 12 months prior to treatment, demonstrating active lesions or predominantly active lesions on pathology.\n\n   Relapsing refractory\u002Fprogressive diffuse systemic sclerosis\n   1. Meets the 2013 ACR classification criteria for systemic sclerosis and is consistent with the diffuse cutaneous subtype (dcSSc).\n   2. Positive for any antinuclear antibody (ANA) or systemic sclerosis-associated autoantibody.\n   3. Evidence of diffuse cutaneous skin sclerosis and\u002For active interstitial lung disease (ILD), defined as ground-glass opacities on high-resolution computed tomography (HRCT).\n   4. Inadequate response to conventional therapy for \\>3 months or disease relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, JAK inhibitors, or any biologic agent, including rituximab, tocilizumab, TNF-α inhibitors (etanercept, adalimumab, infliximab), and telitacicept.\n   5. Progressive disease, defined as either:\n\n   1） Rapid skin progression: mRSS increase \\>25%; or 2） Progressive lung disease: FVC decline ≥10%, or FVC decline ≥5% accompanied by DLCO decline ≥15%.\n\n   Note: Criterion 4 or 5 must be met (either one is sufficient).\n\n   Recurrent refractory\u002Fprogressive inflammatory myopathy:\n\n   1\\. Meets the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including dermatomyositis \\[DM\\], polymyositis \\[PM\\], antisynthetase syndrome \\[ASS\\], and necrotizing myopathy \\[NM\\]).\n\n   2\\. Positive for myositis-specific and\u002For myositis-associated autoantibodies. 3. Evidence of active disease meeting either of the following:\n\n   1\\) Muscle involvement: CMAS \\\u003C 30 and at least two abnormal findings among the following core measures: Physician Global Assessment (PhGA) ≥ 2, Patient\u002FParent Global Assessment (PtGA) ≥ 2, extra-muscular disease activity score ≥ 2, and\u002For serum muscle enzymes ≥ 1.5 × ULN; or 2) Interstitial lung disease (ILD): CMAS ≥ 30 but with active ILD, defined as ground-glass opacities on high-resolution computed tomography (HRCT).\n\n   4\\. Inadequate response to conventional therapy for \\>3 months, or intolerance to treatment-related adverse effects, or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, intravenous immunoglobulin (IVIG), azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, JAK inhibitors, or any biologic agent, including rituximab, tocilizumab, TNF-α inhibitors (etanercept, adalimumab, infliximab), and telitacicept.\n\n   5\\. Progressive disease, defined as worsening myositis or rapidly progressive interstitial lung disease (RP-ILD).\n\n   Note: Criterion 4 or 5 must be met (either one is sufficient). Recurrent refractory sjogren's syndrome\n   1. Meets the 2002 American-European Consensus Group (AECG) classification criteria for primary Sjögren's syndrome or the 2018 Japanese classification criteria.\n   2. Active disease, defined as ESSDAI ≥ 6.\n   3. Positive for anti-SSA\u002FRo antibodies.\n   4. Inadequate response to conventional therapy for \\>3 months or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n   Recurrent\u002Frefractory ANCA-associated vasculitis:\n   1. Meets the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis, including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), and eosinophilic granulomatosis with polyangiitis (EGPA).\n   2. Positive for ANCA, defined as MPO-ANCA and\u002For PR3-ANCA positivity.\n   3. Active vasculitis, defined as Paediatric Vasculitis Activity Score (PVAS) ≥ 15 (maximum score 65).\n   4. Inadequate response to conventional therapy for \\>3 months or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n      Recurrent refractory\u002Fcatastrophic antiphospholipid syndrome:\n\n   1\\. Meets the 2006 revised Sydney classification criteria for primary antiphospholipid syndrome (APS).\n\n   2\\. Positive for antiphospholipid antibodies (aPL) at medium to high titers, defined as lupus anticoagulant (LA), anti-β2-glycoprotein I (anti-β2GPI) IgG\u002FIgM, and\u002For anticardiolipin (aCL) IgG\u002FIgM, with ≥2 positive tests at least 12 weeks apart.\n\n   3\\. Relapsed\u002Frefractory APS, defined as recurrent thrombosis despite standard-of-care therapy, including:\n   1. Anticoagulation with warfarin or another vitamin K antagonist (VKA) with INR maintained within the target therapeutic range, or therapeutic-dose low-molecular-weight heparin (LMWH), and\n   2. Prior treatment with glucocorticoids and cyclophosphamide, with subsequent recurrent thrombosis.\n\n   4\\. Catastrophic antiphospholipid syndrome (CAPS), defined by fulfillment of all four criteria:1) Involvement of three or more organs, systems, and\u002For tissues; 2) Development of manifestations within one week; 3)Histopathologic confirmation of small-vessel thrombosis\u002Focclusion in at least one organ or tissue; 4) aPL positivity.\n\n   Note: Criterion 3 or 4 must be met (either one is sufficient).\n\n   Exclusion Criteria:\n   1. History of severe drug allergy or a known allergic predisposition.\n   2. Presence of, or suspected uncontrolled infection requiring treatment, including fungal, bacterial, viral, or other infections.\n   3. Central nervous system (CNS) disorders, except for prior seizures, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis attributable to the underlying disease, as determined by the investigator.\n   4. Cardiac dysfunction deemed unable to tolerate study treatment (i.e., inadequate cardiac function at the investigator's discretion).\n   5. Known congenital immunoglobulin deficiency.\n   6. Presence of severe congenital structural malformations or syndromic birth defects (e.g., severe cardiovascular malformations, severe CNS malformations), or a confirmed diagnosis of a severe inherited metabolic disorder that, in the investigator's judgment, may significantly increase trial-related risk or interfere with compliance and interpretation of results.\n   7. History of malignancy within the past 5 years.\n   8. End-stage renal disease.\n   9. Evidence of certain chronic\u002Factive infections, including: HBsAg-positive, or HBcAb-positive with peripheral blood HBV DNA above the upper limit of detection; Anti-HCV antibody positive with detectable HCV RNA; HIV antibody positive; Positive syphilis test.\n   10. Psychiatric illness or severe cognitive impairment.\n   11. Participation in another clinical trial within 3 months prior to enrollment.\n   12. Use of immunosuppressive agents with therapeutic effects on the underlying disease within five half-lives prior to enrollment, or use of biologic agents within 4 weeks prior to enrollment.\n   13. Pregnant or planning pregnancy (females).\n   14. Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.","5 Years",{"count":169,"type":21},12,[114],"This exploratory, single-arm, open-label study will evaluate the safety and preliminary efficacy of YTS109 cell therapy in pediatric patients with relapsed\u002Frefractory autoimmune diseases, including systemic lupus erythematosus, diffuse systemic sclerosis, idiopathic inflammatory myopathies, and Sjögren's syndrome, as well as other eligible autoimmune diseases defined by the protocol eligibility criteria. Approximately 12 patients aged 5 to \\\u003C18 years will be enrolled at Children's Hospital of Fudan University and will receive a single intravenous infusion of YTS109 cells. Dose escalation will follow a standard 3+3 design starting at 1.5 × 10\\^6 cells\u002Fkg. The primary objective is to assess the safety and preliminary efficacy of YTS109 cell therapy in this population. Secondary objectives include characterizing the pharmacokinetic and pharmacodynamic profiles of YTS109 cells. Primary endpoints include the type, severity, and frequency of adverse events, along with efficacy assessments.",[173,174,175,61,176,31],"Systemic Lupus Erythematosus (SLE)","Diffuse Systemic Sclerosis","Idiopathic Inflammatory Myopathies (IIMs)","Antiphospholipid Syndrome (APS)","2026-02-23",{"date":179,"type":38},"2026-02-27",{"date":181,"type":21},"2026-03",{"date":183,"type":21},"2030-07",{"name":185,"class":45},"Children's Hospital of Fudan University",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":46},"100612818","pet-assessment-of-disease-activity-and-cardiovascular-disease-risk-in-anca-associated-vasculitis-100612818","NCT07258524","PET Assessment of Disease Activity and Cardiovascular Disease Risk in ANCA-associated Vasculitis","PANDA-VASC","Inclusion Criteria:\n\n1. 18+ years of age\n2. Diagnosis of active AAV (AAV group)\n\nExclusion Criteria:\n\n1. Outwith early treatment window (must receive baseline scan \\\u003C3 weeks from starting treatment)\n2. Pregnancy or breastfeeding\n3. Advanced renal dysfunction (eGFR \\\u003C15ml\u002Fmin\u002F1.73m2)\n4. Adverse reaction or hypersensitivity to proposed radiotracers\n5. Insulin-dependent diabetes mellitus\n6. Patients without mental capacity or willingness to provide informed consent",true,{"count":195,"type":21},120,"OBSERVATIONAL","Antineutrophil cytoplasm antibody (ANCA)-associated vasculitis (AAV) is a severe autoimmune condition characterised by inflammation of small blood vessels. The condition causes multi-organ dysfunction and, if left untreated, is usually fatal. AAV is difficult to diagnose and the degree of disease activity is challenging to monitor. Current methods of disease activity assessment are either inaccurate (blood tests), invasive (biopsy), or non-specific (imaging). Additionally, though modern treatments are effective, patients with AAV remain at a substantially increased risk of cardiovascular disease (CVD) in the long-term. There is therefore an urgent need for a tool which is able to reliably identify disease, and assess long-term CVD risk.\n\nTotal-Body PET imaging with FDG, DOTATATE, and FAPI radiotracers may provide the answer. This study will recruit patients with active AAV, together with a control group of individuals without the disease, to undergo Total-Body FDG, DOTATATE, and FAPI PET scanning and compare the results with established measures of disease activity and CVD risk assessment.\n\nThe investigators believe that Total-Body PET scanning will be capable of accurately identifying AAV disease and those at increased CVD risk. This could enhance understanding and improve the management of those with the condition.\n\nThis study will recruit a group of patients with AAV and a comparator groups of 'matched' individuals without AAV. Comparisons between groups will allow the investigators to ensure that the changes seen are due to AAV disease. The study will recruit a minimum of 30 and a maximum of 90 participants in the AAV group, and a minimum of 10 and maximum of 30 participants in the matched control group.\n\nAAV subjects and matched control subjects will undergo baseline total-body PET scanning with either one, two or three radiotracers (\\[18F\\]-FDG, \\[68Ga\\]-DOTATATE, and \\[68Ga\\]-FAPI). Alongside this they will receive assessment of cardiovascular disease risk including 24-hour blood pressure measurement, arterial stiffness measurement, and retinal scanning. Participants will also supply a blood and urine sample.\n\nFor matched control subjects, their participation will end at this point. Subjects in the AAV group will undergo repeat assessment with total-body PET imaging and cardiovascular disease risk measurement once their condition is in remission (usually after around 3-6 months).\n\nThe investigators will compare PET scan results between groups, and with cardiovascular assessments. This will allow determination of whether total-body PET scanning can identify AAV disease activity, and whether it can inform CVD risk.\n\nAll research activity will be carried out within the University of Edinburgh BioQuarter, including the Royal infirmary of Edinburgh, the Edinburgh Imaging Facility, and Queen's Medical Research Institute.",[61],[146,200,201],"Vasculitis","PET scanning","2026-02-09",{"date":204,"type":38},"2026-02-12",{"date":206,"type":38},"2026-01-28",{"date":208,"type":21},"2029-01",{"name":210,"class":45},"University of Edinburgh",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":46},"100575717","early-phase-1-clinical-study-on-targeted-cd19bcma-car-t-therapy-for-autoimmune-diseases-100575717","NCT06775912","Clinical Study on Targeted CD19\u002FBCMA 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 ≥1×109\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×109\u002FL, lymphocyte count \\>0.3×109\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 RD06-04 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 RD06-04 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.","70 Years",{"count":219,"type":21},18,[24],"This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG",[223,224,225,226,227,228,61],"SLE","Systemic Sclerosis","IIM","NMOSD","MS","MG","2026-01-30",{"date":231,"type":38},"2026-02-02",{"date":233,"type":38},"2025-01-03",{"date":235,"type":21},"2027-06-01",{"name":237,"class":78},"Nanjing Bioheng Biotech Co., Ltd.",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100621641","phase-3-avacopan-added-to-standard-of-care-therapy-in-anca-associated-vasculitis-with-severe-kidney-involvement-100621641","NCT07373262","Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement","Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement: a Randomized, Placebo-controlled, Double-blinded Multicenter Superiority Study","REVERSE","Inclusion Criteria:\n\n* Kidney biopsy before inclusion available (up to 6 weeks before inclusion) or patients agreeing to have a renal biopsy procedure performed no later than prior the visit at week 4\n* Have been newly diagnosed or relapsing active AAV-related RPGN at the time of inclusion (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), according to the American College of Rheumatology\u002FEuropean League Against Rheumatism 2022 (ACR\u002FEULAR 2022) classification criteria, with or without positive ANCA testing)\n* Have an active disease (BVAS ≥ 3, with at least one of the 2 renal items of proteinuria (urinary proteinuria\u002Fcreatininuria \\> 300 mg\u002Fg) and haematuria (\\>10 RBC\u002Fhpf) within the BVAS), and eGFR 0-29 mL\u002Fmin\u002F1.7 m2 at inclusion\n* Be planned to receive a SOC induction regimen by rituximab or cyclophosphamide plus glucocorticoids (+ or - plasma exchanges) for the current AAV flare (rituximab or cyclophosphamide may have been started before the inclusion in the study, maximum 2 weeks before the inclusion)\n* Affiliated person or beneficiary of a social security scheme.\n* Free, informed and written consent signed by the participant and the investigator\n* For women able to procreate, ongoing effective contraception\n\nExclusion Criteria:\n\n* • Irreversible medical conditions likely to affect short-term survival or ability to participate in the study protocol\n\n  * Treatment by \\>3000 mg methylprednisolone or equivalent within the 3 weeks preceding the screening visit\n  * Known eGFR before the AAV flare already \\\u003C35 mL\u002Fmin\u002F1.73m2\n  * Glomerulosclerosis \\>60% or kidney interstitial fibrosis \\>60%, if results of a kidney biopsy are available. If kidney biopsy is performed after inclusion in the study, the patients will continue the study according to the protocol whatever the extent of glomerulosclerosis or interstitial fibrosis.\n  * Pregnant or breast-feeding women, or desire to become pregnant within 24 months. All women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study and another 12 months after (or 12 months after the last rituximab infusion in case of premature termination): Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner.\n  * Hepatic dysfunction defined as:\n\nALT,AST or alkaline phosphatase \\> 3 ×ULN Total Bilirubin \\>2 × ULN, with the exception of participants with Gilbert syndrome who may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN International normalized ratio (INR) \\>1.7 (excepted if patient receive vitamin K antagonists)\n\n* Patients with leukocytes below 2000\u002Fmm3 or neutrophils below 1000\u002Fmm3 will be excluded. However, since patients may have received rituximab or cyclophosphamide before inclusion as a part of induction regimen of the AAV (see inclusion criteria), and both are considered as lymphodepleting agent, mild to moderate lymphopenia (400 - 1500\u002Fmm3) at randomization will be allowed\n* Co-administration of strong CYP3A4 enzyme inducers\n* Known allergy to avacopan\n* Other clinically active systemic autoimmune disease requiring therapy, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), moderate to severe systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjögren's syndrome, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, autoimmune lymphoproliferative syndrome or mixed connective tissue disease.\n* Human immunodeficiency virus (HIV) positivity.\n* Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV).\n* Positive serology for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) excludes the participant regardless of detection of hepatitis B surface antibodies (HBsAb) or HBV-DNA.\n* Participants with a positive HCV antibody test should have HCV ribonucleic acid (RNA) levels measured. Participants with positive (detectable) HCV RNA must be excluded. Chronic hepatitis C participants, who have completed anti- HCV treatment for at least 12 weeks must have a negative HCV RNA result before randomization. Cases of spontaneous HCV clearance should be discussed with sponsor before enrolment.\n* Active viral, bacterial or other infections requiring systemic treatment, or history of recurrent clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.\n* Uncontrolled diabetes mellitus, lung diseases or any other illnesses not related to GPA\u002F MPA that in the opinion of the Investigator would jeopardize the ability of the patient to tolerate glucocorticoids\n* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 3 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).\n* Severe heart failure history (i.e., LVEF \\\u003C 30%)\n* Solid organ transplantation\n* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.\n* Patient under legal protection.","85 Years",{"count":248,"type":21},130,[90],"ANCA-associated vasculitis (AAV) is a rare auto-immune disease, with high mortality in the absence of treatment. There is still an unmet need to define new treatment strategies to reduce drug side effects, as well as to reverse rare cases of refractory AAV and improve the kidney response to improve the long-term outcomes.\n\nSevere forms of AAV-related necrotizing and crescentic rapidly progressive glomerulonephritis (RPGN) (i.e. estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m²) are associated with higher mortality, higher incidence of infections, and long-term consequences including chronic kidney disease (CKD) with subsequent complications (end-stage kidney disease (ESKD) requiring dialysis, cardiovascular diseases) and a burden of financial costs.\n\nIn patients with AAV and RPGN, recent guidelines recommend using a standard-of-care (SOC) immunosuppressive regimen including an induction regimen (rituximab or cyclophosphamide), plus glucocorticoids (GCs) (starting at 60 mg\u002Fday and tapering over 6-12 months) (+ or - plasma exchanges).\n\nSince GCs also participate to the long-term control of AAV, new molecular pathophysiology-driven therapeutic approaches rapidly blocking and\u002For reversing AAV lesions are needed to go beyond the progressive control of AAV using GCs alone. Thus, an add-on approach including GCs-based immunosuppressive regimen plus a new targeted therapy may lead to both AAV control (systemic disease) and improvement of the kidney outcome (organ involvement).\n\nAvacopan a selective inhibitor of the C5a receptor, recently emerged as a new therapeutic option in AAV. In a phase 3 comparative study (that included a small subset of patients with eGFR 15-29 mL\u002Fmin\u002F1.7m2), avacopan was superior to glucocorticoids taper with respect to sustained remission at week 52. In the avacopan arm, the cumulative dose of GCs was dramatically reduced and avacopan was thus proposed as an alternative to GCs rather to a synergic treatment. In the subgroup of patients with eGFR \\\u003C30 mL\u002Fmin\u002F1.73m², avacopan was associated with a better eGFR gain at week 52 compared to prednisone, but data in this population at-risk of worse kidney outcomes are scarce, and did not include patients with eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m², those patients being excluded from the study.\n\nIn the REVERSE study, investigators put forward the hypothesis that avacopan added on GCs regimen may significantly improve the kidney outcome of severe AAV (synergic approach), and thus improve short- and long-term global outcomes (survival, cardiovascular status). REVERSE will thus compare GCs-based SOC + placebo to GCs-based SOC + avacopan.",[30],[253,254],"ANCA-associated vasculitis","avacopan","2026-01-22",{"date":206,"type":38},{"date":258,"type":21},"2026-03-01",{"date":260,"type":21},"2030-07-01",{"name":262,"class":45},"University Hospital, Toulouse",30,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":268,"conditions":273,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":46},"100617166","phase-1-car-t-cell-therapy-targeting-cd19-and-bcmaqt-019c-in-patients-with-relapserefractory-autoimmune-diseases-100617166","NCT07315087","CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse\u002FRefractory Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\nCommon Inclusion Criteria:\n\n1. Age ≥ 18 years old (inclusive), regardless of gender.\n2. Functional requirements for major organs are as follows（Except for abnormalities related to autoimmune disease activity）: 1) Bone marrow function must meet: A. Neutrophil count ≥ 1×109\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g\u002FL; 2) Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤2×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome); 3) Renal function: creatinine clearance rate (CrCl) ≥ 30mL\u002Fminute (calculated by Cockcroft\u002FGault formula, acute CrCl decrease due to the target disease is excluded; LN is excluded).\n3. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative human chorionic gonadotropin (hCG) test within 7 days before study enrollment and not be lactating.\n4. Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nDisease-Specific Inclusion Criteria:\n\nRefractory\u002FRelapsed Systemic Lupus Erythematosus:\n\n1. SLE meeting the 2019 American College of Rheumatology (ACR) \u002FEuropean League Against Rheumatism (EULAR) and classification criteria.\n2. Disease activity score SLEDAI-2000 ≥ 8; or with significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of class III or IV, with or without class V, with an NIH activity index \\> 2, evidence of increased chronicity index; urine protein-to-creatinine ratio \\> 1.0 g\u002Fg, or 24-hour urinary protein \\> 1.0 g).\n3. Definition of refractory or relapsing disease: lack of response after more than 6 months of conventional therapy, or recurrence of disease activity after remission. Conventional therapy is defined as treatment with glucocorticoids in combination with one or more of the following immunomodulatory agents: cyclophosphamide, antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biologics such as rituximab, belimumab, and telitacicept.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Scleroderma fulfilling the 2013 ACR classification criteria.\n2. Positive scleroderma-related antibodies.\n3. Presence of diffuse cutaneous sclerosis or active interstitial lung disease (high-resolution computed tomography (HRCT) showing ground-glass opacities).\n4. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n5. Definition of progressive: Rapid skin progression (mRSS increase \\> 25%); or progression of lung disease (forced vital capacity (FVC) decrease by 10%, or FVC decrease by more than 5% with diffusing capacity of the lung for carbon monoxide (DLCO) decrease by 15%).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRefractory\u002FRelapsed\u002FProgressive Inflammatory Myopathy:\n\n1. Inflammatory myopathy fulfilling the 2017 EULAR\u002FACR classification criteria (including Dermatomyositis (DM), Polymyositis (PM), Anti-Synthetase Syndrome (ASS), and Necrotizing Myopathy (NM)).\n2. Muscle involvement with Manual Muscle Testing-8 (MMT-8) score less than 142 and at least two abnormalities found among the following five core measurements (Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), or extramuscular disease activity score ≥ 2; Health Assessment Questionnaire (HAQ) total score ≥ 0.25; muscle enzyme levels ≥ 1.5×ULN);\n3. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n4. Definition of progressive: Rapid progression of interstitial lung disease within a short period.\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. ANCA-Associated Vasculitis fulfilling 2022 ACR\u002FEULAR criteria, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Positive ANCA-associated antibodies (MPO-ANCA or PR3-ANCA positive).\n3. The Birmingham Vasculitis Activity Scale (BVAS) ≥ 15 points (a total score of 63 points), indicating active vasculitis.\n4. Definition of refractory\u002Frelapsed: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission., or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n\nRefractory\u002FRelapsed Connective Tissue Disease-associated thrombocytopenia:\n\n1. Diagnosis of connective tissue disease established according to the latest classification criteria, including but not limited to systemic lupus erythematosus, primary Sjögren's syndrome, antiphospholipid syndrome, and undifferentiated connective tissue disease.\n2. Confirmed diagnosis of connective tissue disease-associated thrombocytopenia, with platelet count \\\u003C30 × 10\\^9\u002FL, or \\\u003C50 × 10\\^9\u002FL accompanied by a bleeding tendency.\n3. Bone marrow morphology consistent with immune thrombocytopenia.\n4. Prior treatment with at least one course of corticosteroid pulse therapy, or high-dose corticosteroids in combination with one or more immunosuppressants (including biologics) for at least 3 months, without achieving partial remission, or inability to maintain efficacy during steroid tapering.\n\nExclusion Criteria:\n\n1. Subjects with a history of severe drug allergies or allergic tendencies.\n2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.\n3. Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis).\n4. Subjects with insufficient cardiac function.\n5. Subjects with congenital immunoglobulin deficiencies.\n6. History of malignancy within five years.\n7. Subjects with end-stage renal failure(LN is excluded).\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n9. Subjects with psychiatric disorders and severe cognitive impairments.\n10. Subjects who have participated in other clinical trials within the past 3 months prior to enrollment.\n11. Subjects who have received immunosuppressive agents or biologics with therapeutic effects for indications within 5 half-life prior to enrollment.\n12. Pregnant women or women planning to conceive.\n13. Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":169,"type":21},[114],[274,275,276,61,277,278],"SLE - Systemic Lupus Erythematosus","SSc-Systemic Sclerosis","IIM- Idiopathic Inflammatory Myopathies","Connective Tissue Disease-Associated Thrombocytopenia","SLE-ITP","2026-01-15",{"date":281,"type":38},"2026-01-20",{"date":283,"type":21},"2026-01-01",{"date":285,"type":21},"2029-01-18",{"name":287,"class":45},"Institute of Hematology & Blood Diseases Hospital, China",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":46},"100563292","anti-cd19-il-10il15-car-nk-cells-in-refractoryrelapsed-autoimmune-diseases-100563292","NCT06614270","Anti-CD19 IL-10\u002FIL15 CAR-NK Cells in Refractory\u002FRelapsed Autoimmune Diseases","Clinical Study of Core Blood-derived Anti-CD19 IL-10\u002FIL15 CAR-NK in the Treatment of Refractory\u002FRelapsed Autoimmune Diseases","Common inlcusion Criteria:\n\n1. Age 18-65 years old, male or female;\n2. Routine blood count: hemoglobin ≥60g\u002FL, white blood cell count ≥ 2.5×109\u002FL, neutrophil count ≥1.0×109\u002FL (no colony-stimulating factor treatment within 2 weeks before examination);\n3. Liver function: ALT ≤3×ULN, AST≤3×ULN, TBIL≤1.5×ULN;\n4. Coagulation function: international normalized ratio (INR) \\< 1.5×ULN, prothrombin time (PT) \\<1.5×ULN;\n5. Cardiac function: good hemodynamic stability;\n6. Female subjects of childbearing age must have a negative pregnancy test and agree to use effective contraception during the trial;\n7. Voluntarily participate in this study and sign the informed consent form, agreeing to participate in the follow-up as required.\n\nSLE Enrollment Criteria:\n\n1. patients meet the classification criteria of SLE;\n2. Refractory or relapsed cases classified as non-response to standard therapy or disease recurrence after remission. Standard treatment is defined as therapy with at least three agents, including glucocorticoids at a dose \\>1 mg\u002Fkg\u002Fday, together with at least two of the following immunomodulatory drugs administered for more than 6 months: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, iguratimod, antimalarials, and biologic agents, including rituximab, belimumab, or telitacicept.\n\nSystemic Sclerosis (SSc) Enrollment Criteria:\n\n1. Patients who meet the SSc classification criteria of the 2013 ACR\u002FEULAR and have a diagnosis of systemic sclerosis;\n2. the patient\\'s disease duration ≤ 60 months (defined as the onset of the first non-Raynaud\\'s symptoms);\n3. Patient-modified Rodnan skin score (mRSS) ≥10 at the baseline visit; or active interstitial lung disease (ILD): ground-glass opacity on high-resolution computed tomography (HRCT), pulmonary function suggestive of forced vital capacity (FVC) or diffusing capacity for carbon monoxide (DLCO) less than 70% predicted;\n4. A or B needs to be met:\n\nA. Refractory or relapsed cases classified as non-response to standard therapy or disease recurrence after remission. Standard treatment is defined as the use of glucocorticoids and cyclophosphamide, as well as any of the following immunomodulatory drugs, for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tocilizumab, etc.; B. Presence of progressive disease, specifically defined as, within the past 6 months: a) Progression of cutaneous involvement: more than 25% increase in mRSS; or b) progression of lung disease: 10% reduction in FVC, or 5% reduction in FVC with 15% reduction in DLCO.\n\nIdiopathic Inflammatory myopathy enrollment criteria:\n\n1. Diagnosis according to the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies, including dermatomyositis (DM), polymyositis (PM), antisynthetase antibody syndrome (ASS), and immune-mediated necrotizing myositis (IMNM);\n2. patients with muscle involvement with a manual strength test-8 (MMT-8) score less than 142 and at least 2 abnormalities in the following 5 core assessments: Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), Extramuscular Disease Activity Score ≥2 points, Health Assessment Questionnaire (HAQ) total score ≥0.25, muscle enzyme level ≥1.5×ULN); or MMT-8≥142 with active interstitial lung disease (HRCT suggests ground-glass opacities);\n3. Positive myositis-specific antibodies;\n4. A or B needs to be met:\n\nA. Relapsed or refractory patients: relapsed or reactive after remission. Definition of conventional treatment: use of glucocorticoids (more than 1 mg\u002Fkg\u002Fd) and cyclophosphamide and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tetatercept, etc.; B. Patients with progressive disease: rapid progressive interstitial pneumonia in a short period of time.\n\nANCA-associated vasculitis enrollment criteria:\n\n1. Meets the 2022 ACR\u002FEULAR ANCA-ASSOCIATED VASCULITIS CLASSIFICATION CRITERIA, INCLUDING MICROSCOPIC POLYANGIITIS (MPA), GRANULOMATOSIS WITH POLYANGIITIS (MPA);\n2. Positive PR3-ANCA or MPO-ANCA (either previous or current positive);\n3. Birmingham Vasculitis Activity Scale (BVAS) score of ≥ 15 points, and at least 1 major item caused by active vasculitis, or at least 3 non-major items, or at least renal involvement hematuria, proteinuria;\n4. estimated glomerular filtration rate (eGFR) ≥15 mL\u002Fminute\u002F1.73 m2 (MDRD method);\n5. Definition of refractory\u002Frelapsed: Conventional treatment that remains ineffective for more than 6 months, or disease recurrence after remission. Conventional treatment definition: use of glucocorticoids (more than 1 mg\u002Fkg\u002Fday) and cyclophosphamide, as well as any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tocilizumab, etc.\n\nSjögren\\'s syndrome enrollment criteria:\n\n1. Meet the 2002 European and American Consensus Group (AECG) standards or the 2016 ACR\u002FEULAR Primary Sjögren\\'s Syndrome (pSS) classification criteria;\n2. positive anti-SSA\u002FRo-60 antibody;\n3. Definition of disease activity: EULAR Sjögren\\'s Syndrome Disease Activity Index (ESSDAI) score ≥ 5;\n4. Definition of recurrence\u002Frefractory: Conventional treatment that remains ineffective for more than 6 months, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (\\>1 mg\u002Fkg\u002Fday) and cyclophosphamide, as well as any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab.\n\nAntiphospholipid syndrome enrollment criteria:\n\n1. Primary antiphospholipid syndrome meeting the 2006 Sydney criteria;\n2. Medium to high titer phospholipid antibody (aPL) positive: lupus anticoagulant (LA), IgG or IgM anti-β2 glycoprotein 1 antibody (anti-β2-GP1) or anticardiolipin antibody (aCL), at least 2 or more times positive, with an interval of more than 12 weeks;\n3. A or B needs to be met:\n\nA. Definition of refractory\u002Frelapsed: recurrent thrombosis with standard therapy with warfarin or other vitamin K antagonist coagulation (INR maintained within the range required for treatment), or standard therapeutic dose low molecular weight heparin (LMWH) with glucocorticoids and cyclophosphamide; B. Catastrophic antiphospholipid syndrome requires the following four criteria: (1) involvement of ≥ 3 organs, systems, and\u002For tissues (vascular embolism requires radiographic evidence, renal involvement requires a \\>50% increase in creatinine, blood pressure \\> 180\u002F100 mmHg, and\u002For urine protein \\>0.5 g\u002F24 hours); (2) all clinical manifestations appear simultaneously or sequentially within 1 week; (3) Pathological basis for the presence of small vessel occlusion in at least one organ or tissue (evidence of vascular embolism is required for pathological diagnosis, occasionally complicated by vasculitic manifestations); (4) Positive aPL antibody.\n\nCommon Exclusion Criteria:\n\n1. Combined with other connective tissue diseases;\n2. Involvement of important organs: heart (individuals with more severe heart disease, such as angina, myocardial infarction, heart failure, and arrhythmias), kidney (eGFR \\< 15 ml\u002Fmin\u002F1.73m2), liver (ALT\\>3×ULN, AST\\>3×ULN, TBIL \\>1.5×ULN), lung (FVC\\<50% predicted or hemoglobin-corrected DLCO\\<40% predicted), hematologic (leukocyte \\< 2.5×109\u002FL, neutrophil count \\<1.0×109\u002FL, HGB\\<60g\u002FL), etc.;\n3. Abnormal hepatitis B or hepatitis C test indicating active infection or chronic infection, including positive HBsAg or HBcAb test and positive hepatitis C antibody;\n4. Have active tuberculosis or latent tuberculosis;\n5. Human immunodeficiency virus (HIV) serology positivity or known history of HIV infection;\n6. Presence of any known serious active infection (including bacterial, viral, fungal, etc.), including those requiring hospitalization or intravenous antibiotic therapy within 4 weeks prior to screening and oral antibiotic therapy within 2 weeks prior to screening; Those who have various chronic infections and are currently receiving corresponding treatment, such as pneumocystosis, cytomegalovirus, herpes zoster, atypical mycobacteria, etc.;\n7. Patients with primary or secondary immunodeficiency;\n8. IgA deficiency (\\<10 mg\u002FdL) or IgG deficiency (\\<400 mg\u002FdL);\n9. Receiving other investigational drug treatment or participating in any other drug trial within 3 months before screening;\n10. History of documented and confirmed malignancy within 5 years prior to screening, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been appropriately treated or resected;\n11. Patients who are pregnant, breastfeeding, or planning a recent pregnancy, or who are unwilling to use a reliable contraceptive method of contraception for the duration of the study;\n12. Those who have been allergic to human or murine proteins and monoclonal antibodies in the past;\n13. Received live vaccine or live attenuated vaccine within 4 weeks prior to randomization;\n14. Patients who are not expected to comply with the requirements of the protocol or are not expected to complete the trial as planned (such as those with psychiatric disorders, history of alcoholism, drug or other substance abuse);\n15. Other conditions that the investigator considers the patient not suitable to enter the trial.\n\nSystemic Sclerosis Exclusion Criteria:\n\n1. Localized cutaneous SSc;\n2. the duration of the disease is greater than 5 years (defined as the onset of the first non-RP symptom);\n3. SSc-like syndrome related to environmental factors, such as vinyl chloride, bleomycin, etc.;\n4. Any history of scleroderma renal crisis;\n5. intermediate- and high-risk pulmonary hypertension;\n6. Active antral vasodilation.\n\nIdiopathic Inflammatory myopathy exclusion criteria:\n\n1. drug-induced myopathy;\n2. inclusion body myositis;\n3. Tumor-associated myositis (myositis occurring within 2 years of diagnosis of tumor).\n\nANCA-associated vasculitis exclusion criteria:\n\n1. alveolar hemorrhage, requiring invasive lung ventilation, which is expected to last longer than the screening time;\n2. Need for dialysis or plasmapheresis during screening;\n3. Have undergone a kidney transplant.\n\nSjögren\\'s syndrome exclusion criteria:\n\n1. Combined with liver cirrhosis;\n2. Combined with aplastic anemia (AA), myelodysplastic syndrome (MDS) or other myeloproliferative disorders (MPD);\n3. drug-induced thrombocytopenia;\n4. Thrombotic thrombocytopenic purpura (TTP)\u002Fmicrothrombotic vascular disease (TMA).\n\nAntiphospholipid syndrome exclusion criteria:\n\n1. Obstetric APS;\n2. APS incorporates other CTDs;\n3. APS involves the nervous system.",{"count":20,"type":21},[297],"NA","This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10\u002FIL15 CAR-NK cells in patients with refractory\u002Frelapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.",[29,61,300,301,302,27],"Idiopathic Inflammatory Myopathy (IIM)","Sjogren's Syndrome","Antiphospholipid Syndrome","2025-12-21",{"date":305,"type":38},"2025-12-29",{"date":307,"type":38},"2025-01-06",{"date":309,"type":21},"2027-01-06",{"name":311,"class":45},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":316,"conditions":321,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":46},"100588417","phase-1-car-t-cell-therapy-targeting-cd19-and-bcma-in-patients-with-relapserefractory-autoimmune-diseases-100588417","NCT06941129","CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse\u002FRefractory Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\nCommon Inclusion Criteria:\n\n1. Age ≥ 18 years old (inclusive), regardless of gender.\n2. Positive expression of CD19 or BCMA on peripheral blood B cells confirmed by flow cytometry.\n3. Functional requirements for major organs are as follows（Except for abnormalities related to autoimmune disease activity）: 1) Bone marrow function must meet: A. Neutrophil count ≥ 1×109\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g\u002FL; 2) Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤2×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome); 3) Renal function: creatinine clearance rate (CrCl) ≥ 30ml\u002Fminute (calculated by Cockcroft\u002FGault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded).\n4. ECOG score 0-2.\n5. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n6. Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nDisease-Specific Inclusion Criteria\n\nRefractory\u002FRelapsed Systemic Lupus Erythematosus:\n\n1. SLE meeting the 2019 the American College of Rheumatology (ACR) \u002FEuropean League Against Rheumatism (EULAR) and classification criteria.\n2. Disease activity score SLEDAI-2000 ≥ 8; or with significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of class III or IV, with or without class V, with an NIH activity index \\> 2, evidence of increased chronicity index; urine protein-to-creatinine ratio \\> 1.0 g\u002Fg, or 24-hour urinary protein \\> 1.0 g).\n3. Definition of refractory or relapsing disease: lack of response after more than 6 months of conventional therapy, or recurrence of disease activity after remission. Conventional therapy is defined as treatment with glucocorticoids in combination with one or more of the following immunomodulatory agents: cyclophosphamide, antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biologics such as rituximab, belimumab, and telitacicept.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Scleroderma fulfilling the 2013 ACR classification criteria.\n2. Positive scleroderma-related antibodies.\n3. Presence of diffuse cutaneous sclerosis or active interstitial lung disease (high-resolution computed tomography (HRCT) showing ground-glass opacities).\n4. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n5. Definition of progressive: Rapid skin progression (mRSS increase \\> 25%); or progression of lung disease (forced vital capacity (FVC) decrease by 10%, or FVC decrease by more than 5% with diffusing capacity of the lung for carbon monoxide (DLCO) decrease by 15%).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRefractory\u002FRelapsed\u002FProgressive Inflammatory Myopathy:\n\n1. Inflammatory myopathy fulfilling the 2017 EULAR\u002FACR classification criteria (including Dermatomyositis (DM), Polymyositis (PM), Anti-Synthetase Syndrome (ASS), and Necrotizing Myopathy (NM)).\n2. Muscle involvement with Manual Muscle Testing-8 (MMT-8) score less than 142 and at least two abnormalities found among the following five core measurements (Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), or extramuscular disease activity score ≥ 2; Health Assessment Questionnaire (HAQ) total score ≥ 0.25; muscle enzyme levels ≥ 1.5×ULN);\n3. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n4. Definition of progressive: Rapid progression of interstitial lung disease within a short period.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. ANCA-Associated Vasculitis fulfilling 2022 ACR\u002FEULAR criteria, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Positive ANCA-associated antibodies (MPO-ANCA or PR3-ANCA positive).\n3. The Birmingham Vasculitis Activity Scale (BVAS) ≥ 15 points (a total score of 63 points), indicating active vasculitis.\n4. Definition of refractory\u002Frelapsed: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission., or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n\nRefractory\u002FRelapsed Connective Tissue Disease-associated thrombocytopenia\n\n1. Diagnosis of connective tissue disease established according to the latest classification criteria, including but not limited to systemic lupus erythematosus, primary Sjögren's syndrome, antiphospholipid syndrome, and undifferentiated connective tissue disease.\n2. Confirmed diagnosis of connective tissue disease-associated thrombocytopenia, with platelet count \\\u003C30 × 10\\^9\u002FL, or \\\u003C50 × 10\\^9\u002FL accompanied by a bleeding tendency.\n3. Bone marrow morphology consistent with immune thrombocytopenia.\n4. Prior treatment with at least one course of corticosteroid pulse therapy, or high-dose corticosteroids in combination with one or more immunosuppressants (including biologics) for at least 3 months, without achieving partial remission, or inability to maintain efficacy during steroid tapering.\n\nExclusion Criteria:\n\n1. Subjects with a history of severe drug allergies or allergic tendencies.\n2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.\n3. Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis).\n4. Subjects with insufficient cardiac function.\n5. Subjects with congenital immunoglobulin deficiencies.\n6. History of malignancy within five years.\n7. Subjects with end-stage renal failure(LN is excluded).\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n9. Subjects with psychiatric disorders and severe cognitive impairments;\n10. Subjects who have participated in other clinical trials within the past 3 months prior to enrollment.\n11. Subjects who have received immunosuppressive agents or biologics with therapeutic effects for indications within 5 half-life prior to enrollment.\n12. Pregnant women or women planning to conceive.\n13. Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":169,"type":21},[114],[27,29,322,30,277,278],"Inflammatory Myopathy","2025-09-24",{"date":325,"type":38},"2025-09-29",{"date":327,"type":38},"2025-02-11",{"date":329,"type":21},"2028-03-18",{"name":287,"class":45},{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":193,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":358,"locationsCount":46},"100604475","clinical-assessment-for-rheumatologic-disease---research-and-advancement-in-safety-and-efficacy-100604475","NCT07150000","Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE","Inclusion Criteria:\n\n* Participants aged ≥ 18 years\n* Signed written informed consent to participate voluntarily in the study.\n* Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:\n* Rheumatoid arthritis (RA)\n* Psoriatic arthritis (PsA)\n* Axial spondyloarthritis (axSpA)\n* Giant cell arteritis (GCA)\n* Connective tissue diseases, including:\n\n  1. Systemic lupus erythematosus (SLE)\n  2. Systemic sclerosis (SSc)\n  3. Mixed connective tissue disease (MCTD)\n  4. Idiopathic inflammatory myopathies (IIM)\n* ANCA-associated vasculitides (AAV), including:\n\n  1. Microscopic polyangiitis (MPA)\n  2. Granulomatosis with polyangiitis (GPA)\n  3. Eosinophilic granulomatosis with polyangiitis (EGPA)\n* Autoinflammatory diseases, including\n\n  1. Familial Mediterranean fever (FMF)\n  2. Cryopyrin-associated periodic syndromes (CAPS)\n  3. TNF receptor-associated periodic syndrome (TRAPS)\n  4. Adult-onset Still's disease (AOSD)\n\n     Exclusion Criteria:\n* Refusal to participate in the study or inability to provide informed consent.\n\nInclusion Criteria - Healthy Control Group:\n\n* Participants aged ≥ 18 years (capable of providing informed consent).\n* Signed written informed consent to participate voluntarily in the study.\n\nExclusion Criteria - Healthy Control Group:\n\n\\- Presence of a known or active rheumatologic disease.",{"count":195,"type":21},"The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs.\n\nDespite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation.\n\nThe assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy.\n\nThrough this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.",[342,343,344,345,346,347,61,348,29,349,300,350,351],"Rheumatic Diseases","Rheumatoid Arthritis (RA)","Giant Cell Arteritis (GCA)","Psoriatic Arthritis (PsA)","Axial Spondylarthritis (axSpA)","Polymyalgia Rheumatica (PMR)","Connective Tissue Disease (CTD)","Systemic Lupus Erthematosus (SLE)","Autoinflammatory Disease","Gout Arthritis","2025-08-24",{"date":354,"type":38},"2025-09-02",{"date":356,"type":38},"2025-04-01",{"date":126,"type":21},{"name":359,"class":45},"University of Bonn",{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":46},"100579726","phase-1-safety-and-efficacy-of-universal-cd19-targeting-car-t-cells-in-refractory-autoimmune-diseases-100579726","NCT06828042","Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases","A Single-center Clinical Study Evaluating the Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells（QH103） in Refractory Autoimmune Diseases","Inclusion Criteria:\n\nCommon Inclusion Criteria:\n\n1. Age between 18-80 years (inclusive), male or female.\n2. Positive expression of CD19 on peripheral blood B cells by flow cytometry.\n3. Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.\n4. Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg\u002Fday prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed \\>5 mg\u002Fday prednisone (or an equivalent dose). If the subject is receiving antimalarials and\u002For conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.\n5. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.\n6. Willing to participate in the trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\n1. Systemic Lupus Erythematosus (SLE):\n\n   * Meets the 2019 EULAR\u002FACR classification criteria for SLE.\n   * ANA titer ≥1:80, or positive for anti-dsDNA and\u002For anti-Sm antibodies.\n   * Disease activity score (SLEDAI-2000) ≥8.\n2. Sjögren's Syndrome:\n\n   * Meets the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome.\n   * Disease activity score (ESSDAI) ≥5.\n   * Positive for anti-SSA\u002FRo antibodies.\n3. Systemic Sclerosis (SSc):\n\n   * Meets the 2013 EULAR\u002FACR classification criteria for systemic sclerosis.\n   * Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.\n   * At screening, mRSS \\>10; and\u002For active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) \\\u003C70% of predicted values.\n4. Idiopathic Inflammatory Myopathies (IIM):\n\n   * Meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).\n   * For patients with muscle involvement: a. MMT-8 score \\\u003C142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25. Muscle enzyme levels ≥1.5 times the upper normal limit. b. Alternatively, MMT-8 ≥142 but with active ILD (HRCT showing ground-glass opacities).\n   * Positive for myositis-specific antibodies.\n5. ANCA-Associated Vasculitis (AAV):\n\n   * Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.\n   * Positive for ANCA antibodies (current or historical).\n   * Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.\n6. Refractory Antiphospholipid Syndrome (APS):\n\n   * Meets the 2023 ACR\u002FEULAR diagnostic criteria for antiphospholipid syndrome.\n   * Positive for medium-to-high titers of antiphospholipid antibodies (LA, anti-β2-GP1, or ACL IgG\u002FIgM), with at least two positive results within 3 months.\n   * Definition of refractory APS: Disease remains active or relapses after remission, despite 6 months of conventional therapy, including: Anticoagulants (warfarin or standard treatment with vitamin K antagonists maintaining target INR) or low-molecular-weight heparin at standard doses. Glucocorticoids and\u002For immunosuppressants.\n   * Catastrophic APS (CAPS): Must meet all four criteria: a. Involvement of three or more organs, systems, and\u002For tissues. b. Symptoms occurring within one week. c. Histological evidence of small vessel occlusion in at least one organ or tissue. d. Positive for antiphospholipid antibodies (aPL).\n\nNote: Meeting either criterion 3 or 4 is sufficient. Patients with thrombocytopenia may not require anticoagulant therapy.\n\nExclusion Criteria:\n\n1. History of severe drug allergies or allergic constitution.\n2. Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n3. Central nervous system (CNS) diseases caused by autoimmune or non-autoimmune conditions, including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis.\n4. Dysfunction of major organs not meeting the following criteria (exceptions allowed if abnormalities are caused by autoimmune disease): a. Bone marrow function: White blood cell count ≥3×10⁹\u002FL. Neutrophil count ≥1×10⁹\u002FL (without GSF treatment within 2 weeks prior to testing). Hemoglobin ≥60 g\u002FL. Platelet count ≥50×10⁹\u002FL. b. Liver function: ALT ≤3×ULN (exceptions for ALT elevation caused by inflammatory myopathy). AST ≤3×ULN (exceptions for AST elevation caused by inflammatory myopathy). IBIL ≤1.5×ULN (exceptions for Gilbert's syndrome). Total bilirubin ≤3.0×ULN. c. Renal function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin (calculated using the Cockcroft\u002FGault formula, exceptions for acute CrCl decline caused by the disease itself). d. Coagulation function: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN. e. Cardiac function: Stable hemodynamics.\n5. Subjects with congenital immunoglobulin deficiencies.\n6. History of malignancy within the past five years.\n7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA levels exceeding the detection limit; positive hepatitis C virus (HCV) antibodies with detectable HCV RNA in peripheral blood; positive HIV antibodies; or positive syphilis test results.\n8. Subjects with psychiatric disorders or severe cognitive impairment.\n9. Participation in other clinical trials within 3 months prior to enrollment.\n10. Previous treatment with CAR-T therapy.\n11. History of severe adverse reactions to cyclophosphamide or fludarabine.\n12. Any other reason that the investigator determine that subjects cannot be included in this study.","80 Years",{"count":369,"type":21},9,[114,58],"Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS). They affect the quality of life, while in severe cases, they can be life-threatening. Additionally, they impose a heavy economic burden on society. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy.\n\nChimeric Antigen Receptor (CAR)-T cells targeting the B cell surface molecule CD19 have achieved significant clinical progress in acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma, with several CD19 CAR-T therapies approved for marketing worldwide. Increasingly, clinical studies are exploring the use of CD19 CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated.\n\nIn this study, the investigators used γδ T cells as carrier cells to investigate the safety and efficacy of universal CAR-γδ T cells in the treatment of autoimmune diseases.",[373,29,374,61,375,302],"Systemic Lupus Erthematosus","Sjogren Syndrome","Inflammatory Myopathies","2025-08-14",{"date":378,"type":38},"2025-08-20",{"date":380,"type":38},"2025-07-01",{"date":382,"type":21},"2027-12-31",{"name":384,"class":45},"Peking University Third Hospital",{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":394,"briefSummary":395,"conditions":396,"keywords":397,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":403,"leadSponsor":405,"locationsCount":46},"100595503","phase-1-the-safety-efficacy-and-cellular-metabolic-kinetics-of-ct1192-in-treating-patients-with-anti-neutrophil-cytoplasmic-antibody-associated-vasculitis-100595503","NCT07033299","The Safety, Efficacy, and Cellular Metabolic Kinetics of CT1192 in Treating Patients With Anti Neutrophil Cytoplasmic Antibody Associated Vasculitis","A Clinical Study Exploring the Safety, Efficacy, and Cellular Metabolic Kinetics of Universal CD19\u002F20 CAR-T Cell Injection in Anti Neutrophil Cytoplasmic Antibody Associated Vasculitis","Inclusion Criteria:\n\n1. ANCA associated vasculitis that meets the 2022 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) criteria, including microscopic polyangitis, granulomatous polyangitis, and eosinophilic granulomatous polyangitis;\n2. Voluntarily sign the Informed Consent Form (ICF）; When signing the ICF, the age range is between 18 and 60 years old (including 18 and 60 years old), with no gender restrictions;\n3. No systemic active infections (such as infectious pneumonia or tuberculosis) within the first 2 weeks of screening;\n4. Women with fertility (defined as all physiologically capable women) must agree to use effective contraceptive methods from at least 28 days prior to the start of vaginal dialysis to 1 year after CT1192 infusion. Egg donation is strictly prohibited within 1 year after receiving the study treatment infusion during the study period. Male partners with fertility must agree to use effective barrier contraception methods from the start of lymphatic dialysis until 1 year after CT1192 reinfusion, and should not donate semen or sperm throughout the entire study period;\n5. Women with fertility must test negative for serum β - human chorionic gonadotropin (β - hCG) during screening and within 48 hours prior to gonorrhea treatment;\n6. Prior to screening, routine treatment (corticosteroids combined with immunosuppressants) must have been received for at least 6 months but still ineffective, or disease recurrence after remission (BVAS\\>0); During screening, ANCA related antibodies were positive for p-ANCA or c-ANCA;\n7. Birmingham vasculitis activity score (BVAS) ≥ 15 points during the screening period;\n8. Adequate organ function:\n\n1\\) Renal function: defined as a creatinine clearance rate (Cockcroft Gault) calculated without hydration assistance of ≥ 50 mL\u002Fmin; 2) Bone marrow function: defined as neutrophil count (ANC) ≥ 1.0 × 109\u002FL and hemoglobin (Hb) ≥ 90 g\u002FL. Blood transfusions and growth factors must not be used to meet these requirements within 7 days prior to eligibility screening; 3) Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN), total bilirubin ≤ 2 x upper limit of normal (ULN) 4) Coagulation function: defined as International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; 5) Pulmonary function: Blood oxygen saturation (SpO2) ≥ 92% in indoor air (measured by pulse oximeter); 6) Cardiac function: defined as a left ventricular ejection fraction (LVEF) of ≥ 50% evaluated by echocardiography (ECHO) within the first 8 weeks of screening.\n\nExclusion Criteria:\n\n1. Previously received CAR-T cell or other genetically modified T cell therapy, or had a history of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation;\n2. Screening for CD20 monoclonal antibodies such as rituximab used within the previous 6 months;\n3. Use other biological agents such as Mabolizumab during the screening period of 12 weeks;\n4. Allergic or intolerant reactions to Qinglin drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CT1192 preparations or their excipients (including dimethyl sulfoxide (DMSO)), or previous history of other severe allergies such as anaphylactic shock;\n5. Hormone use ≥ 10 mg\u002Fday of prednisone (or equivalent) within 2 weeks prior to CT1192 infusion, with the use of physiological substitutes, topical and inhaled steroids allowed;\n6. Received immunosuppressive agents that affect T cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 2 weeks prior to CT1192 infusion;\n7. Have received JAK inhibitors (tofacitinib, baritinib tablets, lukatinib, etc.) within 2 weeks prior to CT1192 infusion;\n8. Individuals with a history of ≥ grade 2 bleeding or requiring long-term anticoagulant therapy within the 30 days prior to screening; Within 30 days prior to screening, plasma exchange, plasma separation, and hemodialysis treatments have been performed;\n\n10\\. Have received attenuated live vaccine, inactivated vaccine or RNA vaccine within one month before screening; 11. Suffering from malignant tumors within 2 years prior to signing the ICF. Except for the following situations: non melanoma skin cancer that has undergone radical treatment, local prostate cancer, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesions detected by cervical smear, and breast carcinoma in situ that has been completely removed; 12. If a major surgery has been performed within 4 weeks prior to signing the informed consent form, or if a major surgery is planned during the study period, the researcher believes that it would pose unacceptable risks to the participants; During screening, there may be HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-RNA positive); 14. Individuals with central nervous system diseases prior to screening include but are not limited to: cerebrovascular accidents, encephalitis, epilepsy, seizures\u002Fconvulsions, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive dysfunction, organic brain syndrome, or psychiatric disorders; 15. History of any of the following cardiovascular diseases within one month prior to screening: Grade III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant heart diseases; 16. Participate in other clinical studies within the first 3 months of screening or still within the five half lives after the last medication; 17. If there is a history or evidence of suicidal thoughts within the previous 6 months, or any suicidal behavior within the previous 12 months, the researcher believes that there is a significant risk of suicide; 18. Pregnant or lactating women; 19. The researchers determined that the participants had poor compliance, were unable or unwilling to comply with the requirements of the study protocol, or were not suitable to participate in this clinical study for other reasons.","60 Years",{"count":169,"type":21},[114],"A clinical study exploring the safety, efficacy, and cellular metabolic kinetics of universal CD19\u002F20 CAR-T cell injection in anti neutrophil cytoplasmic antibody associated vasculitis.\n\nThis study is a single arm, open label, exploratory dose escalation clinical trial aimed at evaluating the safety, efficacy, and cellular metabolic dynamics of CT1192 cells in patients with ANCA associated vasculitis.",[61],[398],"CT1192","2025-06-23",{"date":401,"type":38},"2025-06-24",{"date":380,"type":21},{"date":404,"type":21},"2027-03-31",{"name":406,"class":45},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":4},"100595698","phase-4-sglt-2-inhibitors-on-albuminuria-in-chronic-kidney-disease-patients-with-lupus-nephritis-and-anca--associated-vasculitis-100595698","NCT07035834","SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis","SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis: Study Design and Protocol","Inclusion Criteria:\n\n* patients aged more than18 years with chronic kidney disease from stage 1 to3, secondary to confirmed LN, without active LN, and AAV\n\nExclusion Criteria:\n\n* 1\\) allergy or intolerance to SGLT2i exposure within 1month before screening; 2) recurrent urinary tract infections; 3) hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase levels \\>2 times the upper normal limits); 4) an eGFR ˂30 ml\u002Fmin\u002F1.73 m2; 5) DM type I and II.",{"count":415,"type":21},40,[141],"The goal of this clinical trial is to investigate the effect of the glifozines on albuminuria in chronic kidney disease patients affected by lupus nephritis and ANCA associated renal vasculitis. It will also learn about the safety of glifozines. The main questions it aims to answer are:\n\n* Does glifozines lower the albuminuria of participants with chronic kidney disease secondary to lupus nephritis and ANCA associated renal vasculitis?\n* What medical problems do participants have when taking glifozines?\n\nParticipants will:\n\n* Take glifozines every day for 6 months.\n* Baseline, 1 month and 6-month visits will be scheduled to collect demographic, clinical, biochemical, and urinary data.\n* A psychosocial assessment will be performed.",[419,61],"Lupus Nephritis (LN)",[421,422,423,424],"Lupus Nephritis","ANCA associated vasculitis","SGLT-2 inhibitors","nephroprotection","2025-06-16",{"date":427,"type":38},"2025-06-25",{"date":429,"type":21},"2025-09",{"date":431,"type":21},"2026-12",{"name":433,"class":45},"Federico II University",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":452,"locationsCount":129},"100591451","phase-1-a-study-of-ol-108-in-relapsedrefractory-autoimmune-diseases-100591451","NCT06980597","A Study of OL-108 in Relapsed\u002FRefractory Autoimmune Diseases","An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-108) in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* General:\n* Adults aged 18-65 years old\n* ECOG 0-2\n* Adequate organ function\n* Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and must agree to use a highly effective contraceptive method starting from the time of lymphodepletion and for 2 years after dosing of the IMP\n* SLE specific:\n\n  a) Fulfilling the 1997 ACE SLE criteria\u002F 2012 SLICC criteria\u002F 2019 ACR\u002FEULAR classification criteria of SLE; b) A positive ANA titer (≥ 1:80) and\u002For presence of anti-dsDNA, or anti-Sm antibodies; c) Active disease at screening, defined as SLEDAI-2K≥8 AND clinical SLEDAI-2K≥6, AND ≥1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥2 organ systems with a BILAG B score (moderate disease activity), AND PGA≥ 1; OR biopsy proven 2003 ISN\u002FRPS class III\u002FIV +\u002F- class V lupus nephritis; d) relapsed or refractory to at least one immunosuppressant or biologic.\n* IIM specific:\n\n  a) Fulfilling the 2017 ACR\u002FEULAR classification criteria for DM, PM, ADM, ASS and IMNM; b) Active disease as defined by at least one of the following criteria: at least one muscle enzyme \\> ULN in the past 4 weeks, active disease by EMG\u002Fmuscle biopsy\u002FMRI in the past 3 months, active DM rash; c)MMT \\\u003C 142 and 2 of the following criteria: VAS patients Global ≥ 2 cm, VAS physician Global ≥ 2 cm, HAQ \\> 0.25, at least one muscle enzyme \\> 1.5x ULN, MDAAT ≥ 2 ; d) CDASI ≥14 if with skin involvement; e) At least one myositis-specific or associated antibody positive; f)relapsed or refractory to at least one immunosuppressant or biologic.\n* SSc specific:\n\n  a)Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc; b) Active disease as defined by one of following: new or progressing skin manifestation\u002Fvital organ involvement within 6 months prior to screening, CRP≥6 mg\u002FL, ESR≥28 mm\u002Fh, platelet ≥330 × 10⁹\u002FL; c) mRSS score \\>10; d)relapsed or refractory to at least one immunosuppressant or biologic.\n* AAV specific:\n\n  1. Fulfilling the 2022 ACR\u002FEULAR classification criteria for MPA\u002FGPA; b) Presence of ANCA to either proteinase 3 or myeloperoxidase; c)At least one major or three non-major items or at least two renal items of hematuria and proteinuria on the BVAS; d)relapsed or refractory to at least one immunosuppressant or biologic.\n\nExclusion Criteria:\n\n* Active uncontrolled infection\n* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load\n* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load\n* HIV antibody positive\n* Syphilis antibody positive\n* Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI)\n* History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections)\n* Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)\n* Uncontrolled hypertension (blood pressure ≥160\u002F100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment\n* history of organ transplant\n* Pregnancy or lactating women\n* Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug\n* Use of biologics within 3 months, stem cell transplant or CAR-T within 6 months prior to the start of study drug\n* Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1\n* Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome.\n* Limited to patients diagnosed with SLE: patients with active neuropsychatric SLE\n* Limited to patients diagnosed with IIM: Severe involvement of respiratory muscles affecting ventilatory function; permanent muscle weakness related to IIM; other inflammatory or non-inflammatory myopathy: inclusion body myositis, infectious myopathy, metabolic myopathy, muscular dystrophy or a family history of muscular dystrophy, drug-induced or endocrine-induced myositis, and juvenile myositis\n* Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure\n* Limited to patients diagnosed with AAV: Central nervous system vasculitis; Alveolar hemorrhage requiring invasive pulmonary ventilation",{"count":442,"type":21},44,[114],"This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed\u002Frefractory autoimmune diseases.",[173,300,29,61],"2025-05-12",{"date":448,"type":38},"2025-05-20",{"date":450,"type":21},"2025-06",{"date":126,"type":21},{"name":453,"class":45},"Beijing GoBroad Hospital",{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":479},"100563094","phase-4-avacopan-vs-reduced-dose-glucocorticoids-in-anca-associated-vasculitis-100563094","NCT06611696","Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis","Avacopan With Short-term Reduced-dose Glucocorticoids vs Reduced-dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-associated Vasculitis","ARRIA","Inclusion Criteria:\n\n1. Provision of written informed consent by a patient or a surrogate decision maker\n2. Age=\\>18 years\n3. New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis, microscopic polyangiitis) consistent with the 2012 Chapel Hill consensus definitions and 2022 EULAR\u002FACR classification criteria\n4. Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA\n\nExclusion Criteria:\n\n1. Prior treatment for ANCA-associated vasculitis before trial entry\n2. ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml\u002Fmin) or alveolar hemorrhage (oxygen inhalation more than 2L\u002Fmin)\n3. Presence of another multisystem autoimmune disease\n4. Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection\n5. Desire to bear children, pregnancy or lactating\n6. History of malignancy within the past 5 years or any evidence of persistent malignancy\n7. Ongoing or recent (last 1 year) evidence of active tuberculosis\n8. History of severe allergy or anaphylaxis to monoclonal antibody therapy\n9. Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg\n10. Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months\n11. Past history of medication of avacopan\n12. Patients can not take avacopan and prednisolone orally\n13. Other conditions, in the investigator\\'s opinion, inappropriate for the trial entry",{"count":463,"type":21},160,[141],"The goal of this clinical trial is to learn if avacopan in combination with short-term (4 weeks) reduced-dose glucocorticoid and rituximab works to treat patients with newly-onset ANCA-associated vasculitis. It will also learn about the long-term safety of avacopan. The main questions it aims to answer are:\n\nIs avacopan in combination with short-term reduced-dose glucocorticoid and rituximab as effective as the combination of 20 week reduced-dose glucocorticoid and rituximab in the proportion of the patients achieving remission? Does avacopan lower the relapse rate compared to the 6 monthly rituximab maintenance therapy? What medical problems do participants have when taking long-term avacopan?\n\nParticipants will:\n\nBe treated with avacopan in combination with short-term (until 4 weeks) reduced-dose glucocorticoid and rituximab (at 0 week) or reduced-dose glucocorticoid (until 20 weeks) and rituximab (at 0, 26, 52 and 78 weeks).\n\nBe assessed at 0, 4, 8, 16, 26, 52, 78 and 104 weeks regarding disease status (remission\u002Frelapse), disease activity by Birmingham Vasculitis Activity Score ver3, disease damage by Vasculitis Damage Index and adverse events.\n\nThe primary endpoint is remission rates at 26 weeks.",[61],[468,469,254,253],"microscopic polyangiitis","granulomatosis with polyangiitis","2025-05-01",{"date":472,"type":38},"2025-05-04",{"date":474,"type":38},"2024-11-15",{"date":476,"type":21},"2028-09-30",{"name":478,"class":45},"Chiba University",22,{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":193,"sex":488,"minAge":489,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":492,"conditions":493,"keywords":501,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":516,"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":491,"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.",[344,347,61,28,494,343,345,495,496,497,498,499,500],"IgG4-Related Diseases","Connective Tissue Disease","Sarcoidosis","Interstitial Lung Disease Due to Systemic Disease (Disorder)","Interstitial Lung Disease (ILD)","Asthma Bronchiale","COPD",[502,200,503,504,505,506,28,494,507,508,495,496,509],"Autoimmune Diseases","Large Vessel Vasculitis","Giant Cell Arteritis","Polymyalgia Rheumatica","ANCA Associated Vasculitis","Rheumatoid Arthritis","Psoriatic Arthritis","Interstitial Lung Disease","2025-04-07",{"date":512,"type":38},"2025-04-10",{"date":474,"type":38},{"date":515,"type":21},"2026-07",{"name":359,"class":45},{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":367,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":4},"100579235","phase-1-safety-and-efficacy-of-universal-car-t-cells-uwd-cd19-combined-with-immunosuppressants-in-the-treatment-of-refractory-autoimmune-diseases-100579235","NCT06821659","Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age between 18-80 years (inclusive), male or female.\n2. \\>40kg.\n3. Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.\n4. Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg\u002Fday prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed \\>5 mg\u002Fday prednisone (or an equivalent dose). If the subject is receiving antimalarials and\u002For conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.\n5. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.\n6. Willing to participate in the trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\nSystemic Lupus Erythematosus (SLE):\n\n1. Meets the 2019 EULAR\u002FACR classification criteria for SLE.\n2. ANA titer ≥1:80, or positive for anti-dsDNA and\u002For anti-Sm antibodies.\n3. Disease activity score (SLEDAI-2000) ≥8.\n\nSjögren's Syndrome:\n\n1. Meets the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome.\n2. Disease activity score (ESSDAI) ≥5.\n3. Positive for anti-SSA\u002FRo antibodies.\n\nSystemic Sclerosis (SSc):\n\n1. Meets the 2013 EULAR\u002FACR classification criteria for systemic sclerosis.\n2. Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.\n3. At screening, mRSS \\>10; and\u002For active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) \\\u003C70% of predicted values.\n\nIdiopathic Inflammatory Myopathies (IIM):\n\n1. Meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).\n2. For patients with muscle involvement: a. MMT-8 score \\\u003C142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25. Muscle enzyme levels ≥1.5 times the upper normal limit. b. Alternatively, MMT-8 ≥142 but with active ILD (HRCT showing ground-glass opacities).\n3. Positive for myositis-specific antibodies.\n\nANCA-Associated Vasculitis (AAV):\n\n1. Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.\n2. Positive for ANCA antibodies (current or historical).\n3. Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.\n\nExclusion Criteria:\n\n1. Subjects with a history of alcohol abuse or substance abuse within the past 24 weeks;\n2. Subjects with other psychiatric disorders such as schizophrenia or major depressive disorder;\n3. Subjects with a history of malignancies other than B-cell lymphoma;\n4. Subjects with overlapping diseases that affect the assessment of disease activity;\n5. Subjects with infections such as human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency virus infection, or chronic hepatitis B or C;\n6. Subjects with known active tuberculosis (TB) infection or bacterial infections;\n7. Subjects with a history of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, active arrhythmia, or other clinically significant heart diseases within 6 months prior to screening;\n8. Subjects with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n9. Subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels ≥3×ULN, or bilirubin \\>1.5×ULN, excluding abnormalities caused by theautoimmune disease;\n10. Subjects with chronic kidney failure stage 4 or above, defined as an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² or serum creatinine \\>2.5 mg\u002FdL;\n11. At the screening visit, subjects with any of the following significant hematologic abnormalities caused by bone marrow suppression, excluding abnormalities due to the autoimmune disease:\n\n    1. Hemoglobin \\\u003C70 g\u002FL;\n    2. Absolute neutrophil count \\\u003C500\u002Fmm³;\n    3. Platelet count \\\u003C50,000\u002Fmm³;\n12. Subjects with a history of severe adverse reactions to cyclophosphamide or fludarabine;\n13. Subjects with a prior history of CAR-T therapy;\n14. Subjects who received live vaccines within 30 days prior to CAR-T cell infusion;\n15. Subjects deemed unsuitable for participation in the study by the investigator.",{"count":369,"type":21},[114,58],"Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy. Clinical studies are exploring the use of CD19-targeting CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, we investigate the safety and efficacy of universal CD19-targeting CAR T cells in the treatment of autoimmune diseases.",[373,29,375,61,374],"2025-02-10",{"date":529,"type":38},"2025-02-12",{"date":531,"type":21},"2025-03-01",{"date":533,"type":21},"2028-12-31",{"name":384,"class":45},{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":545,"conditions":546,"keywords":549,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":46},"100565491","rare-autoimmune-self-management-programme-development-100565491","NCT06642870","Rare AutoImmune SElf-management Programme Development","Rare Autoimmune Self-management Programme Development","RAISE","Inclusion Criteria:\n\n1. Diagnosis of a rare rheumatic condition made by hospital doctor or secondary care: including lupus, systemic vasculitis, myositis, Sjogren syndrome (participant self-report)\n2. Ability to give informed consent (with translation support if needed)\n\nExclusion Criteria:\n\n\\-",{"count":544,"type":21},360,"The rare autoimmune rheumatic diseases (RAIRDs) are life-long multi-system diseases that are life or organ threatening. RAIRDs can impair quality of life similar to chronic diseases such as heart failure. The aim of the study is to explore content and structure of a support programme for people with RAIRDs in focus groups and survey meetings.",[373,547,548,29,61,374],"Systemic Vasculitis","Inflammatory Myositis",[550,551,552],"Rare autoimmune rheumatic diseases","Self-management","Psychological support","2024-10-14",{"date":555,"type":38},"2024-10-15",{"date":557,"type":21},"2024-10",{"date":559,"type":21},"2026-04",{"name":561,"class":45},"University of the West of England"]