[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anca-associated-vasculitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anca-associated-vasculitis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,48,77,102,133,173,203,225,251,273,300,328,352,375,402,428,452,476,496,522,546,568,594,615],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100593731","epithelial-dysmetabolism-and-renal-fibrosis-in-anca-vasculitis-100593731",false,"NCT07010250","Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis","PROTECT-Fi","Inclusion Criteria:\n\n* Patients with an indication for initial diagnostic PBR on native kidney\n* 18 ans ≥ Age ≤ 90 ans\n* Affiliation to french health insurance\n* Patient having given consent\n\nFor the ANCA vasculitis group:\n\n• Diagnosis of ANCA vasculitis retained on renal biopsy with ANCA anti-proteinase 3 (PR3) or ANCA anti-myeloperoxidase (MPO)\n\nFor the control groups:\n\n• Diagnosis retained after the renal biopsy\n\n* Interstitial Nephritis\n* Or glomerular nephropathy such as minimal change nephropathy\n* Or Segmental hyalinosis in itscollapsing form\n* Or Extramembranous Glomerulopathy,\n* Or glomerulopathy with mesangial IgA deposits\n* Or diabetic nephropathy.\n\nExclusion Criteria:\n\n* Kidney transplant patient\n* Patient on dialysis (hemodialysis or peritoneal dialysis)\n* Patient under legal protection, guardianship or curatorship\n* Pregnancy or breastfeeding\n* Enrollement in an interventional study except studies relating to ANCA vasculitis and nephropathy with mesangial IgA deposits.","ALL","18 Years","90 Years",{"count":20,"type":21},146,"ESTIMATED","OBSERVATIONAL","The project is to explore in humans the hypothesis of the link between the alteration of tubulo-interstitial metabolism and the rate of deterioration of renal function by comparing various nephropathies.",[25,26,27,28,29,30,31],"ANCA Associated Vasculitis","Extramembranous Glomerulopathy","Nephrotic Syndrome, Minimal Change","Interstitial Nephritis","IgA Nephropathy","Segmental Hyalinosis","Diabetic Nephropathies",[33,34],"nephropathy","cohort","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2025-11-03",{"date":43,"type":21},"2029-11-02",{"name":45,"class":46},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100511985","phase-3-a-trial-to-evaluate-the-efficacy-of-pioglitazone-to-promote-renal-tolerance-in-anca-associated-vasculitis---renato-trial-100511985","NCT05946564","A Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO Trial","A Multicenter Randomized Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO","RENATO","Inclusion Criteria:\n\n* Newly-diagnosed or relapsing ANCA-associated vasculitis, i.e. granulomatosis with polyangitis (GPA) or microscopic polyangiitis (MPA), according to ACR 1990 criteria and\u002For revised Chapel Hill Consensus Conference definitions and\u002For European Medical Agency algorithm, with an active disease defined as a BVAS ≥3\n* Presence of proteinuria (UPCR \\>300 mg\u002Fg), haematuria (\\>10 RBC\u002Fhpf), and eGFR ≥15 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula) at inclusion (\\\u003C1 month)\n* Recent (\\\u003C4 weeks) renal biopsy that confirms active renal involvement of ANCA-associated vasculitis\n* Patients aged of 18 to 80 years\n* Participant written informed consent prior to participation in the study\n* Participants affiliated to a French health insurance system (registered or being a beneficiary of such a scheme)\n\nExclusion Criteria:\n\n* Alveolar haemorrhage requiring pulmonary ventilation support at inclusion\n* Patients with eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss)\n* Active cancer (except non-melanoma skin cancer) within the past 24 months\n* Active severe bacterial, viral or fungal infectious disease\n* Past history of bladder or urinary tract cancer\n* History of Class 3\u002F4 congestive heart failure symptoms, any time\n* History of Class 2 heart failure symptoms within the past 3 months and\u002For ejection fraction \\\u003C40% on recent echocardiography (\\\u003C1 month)\n* Transaminases levels above 2 times the normal range value (\\\u003C1 month) or any severe chronic liver disease\n* Positive serology for HIV, HBV (Ag HBs positivity) or active HCV infection at inclusion\n* Presence of neutropenia \\\u003C1000 cells\u002Fl (\\\u003C1 month)\n* History of intolerance to any thiazolidinedione (including Pioglitazone), to rituximab or any excipient listed in SmPc\n* Diabetic ketoacidosis, any time\n* A pre-existing or an important risk of new-onset macular edema (confirmed by an ophthalmological examination)\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 (estrogen 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* Severe neurologic or psychiatric disease (e.g., dementia or schizophrenia)\n* Kidney transplant recipients\n* Cyclophosphamide or rituximab (dose \\> 375 mg\u002Fm2) use within 26 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the first rituximab dose. Patients that have initiated induction therapy with rituximab for the actual flare, can be included in the present study within 48h following the first rituximab infusion\n* Intravenous glucocorticoids, \\>3000 mg methylprednisolone equivalent, within 4 weeks prior to screening\n* Patients who have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening\n* Current participation in another research study involving a therapeutic intervention. Participation to an observational research, or a non-interventional research is allowed\n* Patients under guardianship or curators and protected adults\n* Patients not able to understand and follow study procedures\n* Patients on AME (Aide Médicale de l'Etat = State Medical Assistance)","80 Years",{"count":58,"type":21},126,"INTERVENTIONAL",[61],"PHASE3","The RENATO trial is a multicenter randomized controlled trial that evaluates the efficacy of pioglitazone to improve renal outcomes in ANCA-associated vasculitis.\n\nPatients with biopsy-proven kidney involvement of ANCA vasculitis will be included in this trial at diagnosis. All patients will receive a standard of care immunosuppressive (SOC) therapy combining corticosteroids and rituximab (375 mg\u002Fm2\u002Fweek for 4 consecutive weals followed by 500 mg re-infusion every 6 months). They will be randomized 1:1 to receive either pioglitazone 30 mg\u002Fday or placebo for 6 months, on top of SOC. The primary objective of this trial is to demonstrate that pioglitazone reduces kidney damage, reflected by the early improvement of proteinuria and serum creatinine levels. The secondary objectives will be to assess the efficacy of this drug on the reduction of hypertension and metabolic effects of glucocorticoids, to measure its impact on vasculitis activity and to evaluate the safety profile of pioglitazone in this population.",[25,64,65],"Rapidly Progressive Glomerulonephritis","Crescentic Glomerulonephritis",[67,68],"ANCA","vasculitis",{"date":70,"type":39},"2026-07-01",{"date":72,"type":39},"2023-10-24",{"date":74,"type":21},"2028-11",{"name":45,"class":46},25,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":67,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":59,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},"100467294","biocollection-of-patients-with-anca-associated-vasculitis-100467294","NCT05364892","Biocollection of Patients With ANCA Associated Vasculitis","Biocollection of Patients With ANCA Associated Vasculitis Diagnosed Within the CERAINO Autoimmune Disease Reference Center, Part of the Global BRAISE Project (B-dependent Rare AutoImmune DiseaSES","Inclusion Criteria:\n\n* Major patients with no upper age limit.\n* Patients assessed as part of the reference centre for rare autoimmune diseases at the CHRU in Brest.\n* Patients for whom a diagnosis of ANCA-associated vasculitis is made by the physician in charge of the patient, according to the definitions of the Chapel-Hill Consensus Conference.\n* Patient affiliated with Social Security\n* Patient who has signed written informed consent\n\nExclusion Criteria:\n\n* Minor\n* Patients unable to consent.\n* Patients refusing to participate in research\n* Patient under legal protection (tutelage, curatorship)\n* Pregnant or lactating women\n* Hemoglobin (Hb) \\\u003C 7g\u002FdL",true,"99 Years",{"count":87,"type":21},100,[89],"NA","As rare disease, vasculitis affects a small number of patients, the cohorts available in the literature are few and the pathophysiological mechanisms remain to be elucidated. The collection of standardized data within a patientheque as part of a multi-year follow-up will facilitate the study of the characteristics of these diseases. This may, in particular, address the main objective of identifying predictors of relapse, as well as secondary objectives for predictive factors of mortality, infectious, cardiovascular or neoplastic complications that affect the prognosis of vasculitis in order to establish a more appropriate management of the patients concerned.",[92],"ANCA-associated Vasculitis","2026-06-24",{"date":95,"type":39},"2026-06-25",{"date":97,"type":39},"2022-10-27",{"date":99,"type":21},"2032-10-27",{"name":101,"class":46},"University Hospital, Brest",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":84,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":111,"conditions":112,"keywords":118,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":47},"100228924","studies-of-the-natural-history-pathogenesis-and-outcome-of-idiopathic-systemic-vasculitis-100228924","NCT02257866","Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis","* INCLUSION CRITERIA:\n\nSUBJECTS WITH VASCULITIS\n\n* Subjects who fulfill modified versions of the 1990 American College of Rheumatology (ACR) Classification Criteria for GPA31 and PAN\n* Subjects who fulfill the 1990 ACR Classification Criteria for EGPA, GCA, and TAK\n* Subjects who fulfill the 2012 Chapel Hill Nomenclature definition for MPA\n* Subjects with other suspected systemic or single-organ vasculitides\n\nHEALTHY VOLUNTEERS\n\n-Volunteers able to provide consent, or in the case of minors, assent\n\nEXCLUSION CRITERIA:\n\nSUBJECTS WITH VASCULITIS:\n\n* Subjects less than 3 years of age\n* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion\n* Inability to provide consent, or in the case of minors, assent\n* Subjects with bleeding diathesis or on anticoagulant medications (e.g. coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participation in nasal brushing or biopsy studies\n\nHEALTHY VOLUNTEERS\n\n* Volunteers less than 3 years of age\n* Diagnosis of vasculitis or other autoimmune\u002Fautoinflamamtory disease, including systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, mixed connective tissue disease or any overlap autoimmune syndrome\n* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion\n* Pregnant (by history of last menstrual period) or breast feeding subjects\n* Subjects with bleeding diathesis or taking anticoagulant medications (eg coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participating in nasal brushing studies","3 Years",{"count":110,"type":21},4000,"Background:\n\n\\- Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can cause many medical problems. Few tests can diagnose the disease, and none can reliably predict a relapse. Researchers want to study people s genes and follow people over time to see how the disease affects them.\n\nObjective:\n\n\\- To learn the signs, symptoms, imaging tests, genetic markers, and blood tests that can help identify people with vasculitis and predict what will happen to them over time.\n\nEligibility:\n\n* People age 3 and older who have or are thought to have vasculitis, or are related to someone with it.\n* Healthy volunteers.\n\nDesign:\n\n* Participants will be evaluated by a doctor who has expertise caring for patients with vasculitis.\n* Participants will give a blood sample. Some will give a urine sample.\n* Some participants may have brushings or biopsies taken from the inside lining of the nose.\n* Images of participants blood vessels may be taken using scans. For some scans, participants will lie on a table that moves in and out of a cylinder that takes pictures. For some scans, a contrast agent may be injected into an arm vein. Other scans may use a radioactive form of sugar. Healthy minors will not have scans.\n* Some participants will answer questionnaires. - Some participants will have their tests done at NIH. Others will have their doctor take the blood, saliva, or cheek swab samples and send them to NIH.\n* Some participants will have one visit lasting 1-2 (but sometimes up to 4) days. Some participants may have follow-up visits every 3 - 6 months, indefinitely.",[113,114,115,116,117],"Takayasu's Arteritis","Giant Cell Arteritis","Polyarteritis Nodosa","Relapsing Polychondritis","ANCA-Associated Vasculitis",[115,119,120,116,121,122],"Takayasu's Arthritis","Giant Cell Arthritis","Antineutrophil Cytoplasmic Antibodies","Natural History","2026-06-13",{"date":125,"type":39},"2026-06-16",{"date":127,"type":39},"2014-09-29",{"date":129,"type":21},"2050-01-01",{"name":131,"class":132},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":142,"conditions":143,"keywords":156,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":47},"100598885","eacvi-study-on-multimodality-cardiovascular-imaging-of-inflammatory-cardiovascular-diseases-100598885","NCT07077304","EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases","EACVI-INFLAME","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ability to provide informed non-opposition\n3. Referred for a CMR and\u002For nuclear imaging exam\n\nAND a suspicion of one of the following ICARDs :\n\n1. Suspected Myocarditis (acute or chronic, and whatever the aetiologies)\n2. Suspected Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA)\n3. Suspected Tako-Tsubo\n4. Suspected Pericarditis (acute or chronic, and whatever the aetiologies)\n5. Suspected Connective tissue disease with cardiovascular involvement:\n\n   * Systemic sclerosis\n   * Systemic lupus erythematosus\n   * Antiphospholipid syndrome\n   * Idiopathic inflammatory myopathies\n   * Rheumatoid arthritis, spondylarthritis\n6. Suspected Vasculitis with cardiovascular involvement:\n\n   * Small-vessel vasculitis (ANCA…)\n   * Large vessel vasculitis (Behcet disease, Takayasu…)\n7. Suspected Inflammatory disease with cardiovascular involvement:\n\n   * Sarcoidosis\n   * Still disease\n\nExclusion Criteria:\n\n1. Inability to provide non-opposition\n2. History of heart transplant",{"count":141,"type":21},5000,"Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases (ICARDs) encompass cardiovascular involvement in connective tissue diseases, vasculitis, and primary inflammatory cardiac processes affecting all layers of the heart. ICARDs are associated with increased cardiovascular morbidity and mortality, independently of traditional risk factors, via multiple pathophysiological mechanisms.\n\nDiagnosis and prognosis are challenged by the heterogeneity of clinical presentations. Multimodality cardiovascular imaging - including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, and positron emission tomography (PET) - plays a central role in detecting and characterizing inflammatory involvement, and may offer prognostic insights.\n\nGiven the limited data on the diagnostic and prognostic utility of these imaging modalities in ICARDs, the EACVI-INFLAME study aims to assess the prevalence of confirmed cardiovascular involvement in patients with suspected or established ICARDs undergoing CMR and\u002For cardiac PET in a multicentric international cohort.",[144,25,145,146,147,148,149,150,151,152,153,154,155],"Myocarditis","Pericarditis","Systemic Sclerosis","Systemic Lupus Erythematosus","Idiopathic Inflammatory Myopathies","Rheumatoid Arthritis","Spondylarthritis","Behcet Disease","Takayasu Arteritis","Sarcoidosis","Still Disease","Tako Tsubo Cardiomyopathy",[157,158,159,160,161,162,163,164],"Cardiovascular disease","Auto-immune disease","Auto-inflammatory disease","Rheumatic disease","CMR","PET","multimodality imaging","ICARD","2026-06-03",{"date":167,"type":39},"2026-06-05",{"date":169,"type":39},"2025-11-19",{"date":171,"type":21},"2028-10-30",{"name":45,"class":46},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":59,"phases":183,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":202},"100640182","early-phase-1-cd19bcma-targeted-universal-car-t-cell-injection-for-the-treatment-of-autoimmune-diseases-100640182","NCT07596680","CD19\u002FBCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases","Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CD19\u002FBCMA-Targeted CAR-T Cell Injection in Patients With Autoantibody-Mediated Autoimmune Diseases","Inclusion Criteria\n\n1. General Inclusion Criteria (All Patients)\n\n   1. Voluntarily provides written informed consent.\n   2. Age ≥18 and ≤70 years, any gender.\n   3. Adequate organ function:\n\n      * ALT and AST ≤3×ULN; total bilirubin ≤2×ULN (excluding Gilbert syndrome).\n      * Creatinine ≤1.5×ULN or creatinine clearance ≥40 mL\u002Fmin.\n      * Neutrophils ≥1×10⁹\u002FL; hemoglobin ≥60 g\u002FL; platelets ≥20×10⁹\u002FL; lymphocytes \\>0.3×10⁹\u002FL.\n      * INR ≤1.5×ULN or PT ≤1.5×ULN.\n      * Resting room-air SpO₂ ≥92%.\n      * LVEF ≥50% on echocardiogram.\n   4. Negative serum or urine pregnancy test for females of childbearing potential at screening.\n   5. Highly effective contraception required from 28 days before lymphodepletion until 12 months after RD06-05 infusion for females; effective barrier contraception required from lymphodepletion until 12 months after RD06-05 infusion for males, with no sperm donation during the study.\n2. For SLE Patients\n\n   1. Diagnosis of SLE per 2019 EULAR\u002FACR or 2012 SLICC criteria.\n   2. Active disease despite ≥2 months of stable (≥2 weeks) treatment with glucocorticoids plus immunosuppressants and\u002For biologics; prednisone ≥7.5 mg\u002Fday or equivalent.\n   3. Positive ANA, anti-dsDNA antibody, and\u002For anti-Smith antibody at screening.\n   4. SLEDAI-2K \\>6 and clinical SLEDAI-2K ≥4 at screening. Patients with lupus nephritis (proteinuria \\>0.5 g\u002F24h, UPCR \\>500 mg\u002Fg, or active urinary sediment) are exempt from clinical SLEDAI-2K requirement.\n   5. Physician Global Assessment (PGA) ≥1.0 (0-3 VAS) at screening.\n3. For SSc Patients\n\n   1. Diagnosis of SSc per 2013 ACR\u002FEULAR criteria.\n   2. Diffuse cutaneous SSc at screening.\n   3. Active disease defined by at least one of: new SSc within 2 years; new\u002Fworsening skin or thoracic\u002Fabdominal involvement within 6 months; worsening skin thickening (mRSS ≥2); tendon friction rubs within 3 months; worsening respiratory symptoms with FVC decline ≥5% predicted or DLCO decline ≥10% predicted; or ILD progression on HRCT compared to 12 months prior.\n   4. Refractory or relapsing disease after \\>6 months of conventional therapy including glucocorticoids, cyclophosphamide, immunosuppressants, and\u002For biologics.\n4. For AAV Patients\n\n   1. Diagnosis of ANCA-associated vasculitis (MPA, GPA, EGPA) per 2022 ACR\u002FEULAR criteria.\n   2. Positive MPO-ANCA or PR3-ANCA.\n   3. BVAS with at least 1 major item, 3 minor items, or 2 renal items.\n   4. Failure of standard of care: no remission after ≥4 months of glucocorticoids plus cyclophosphamide\u002Frituximab; relapse after prior remission; or persistent active disease despite ≥6 months of SOC.\n5. For IIM Patients\n\n   1. Diagnosis of IIM (DM, ASS, IMNM) per 2017 ACR\u002FEULAR criteria (probability ≥55%).\n   2. Active disease defined by ≥2 abnormal core measures, or active myositis on muscle MRI, or active inflammation on muscle biopsy within 16 weeks.\n   3. Positive myositis-specific autoantibodies.\n   4. Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and\u002For biologics.\n6. For pSS Patients\n\n   1. Diagnosis of primary Sjögren's syndrome per 2016 ACR\u002FEULAR criteria.\n   2. Positive anti-SSA\u002FRo antibody.\n   3. ESSDAI ≥6 at screening.\n   4. Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and\u002For biologics.\n\nExclusion Criteria:\n\n1. General Exclusion Criteria (All Patients):\n\n   1. Coexisting autoimmune disease confounding disease activity\u002Fsafety (stable ≥3 months may be eligible with approval).\n   2. Anti-CD20 mAb\u002FT-cell engager within 3 months; CD19\u002FBCMA-targeted therapy within 6 months (exception with CD19⁺ B-cell \\> LLN and approval).\n   3. Rapidly progressive glomerulonephritis (RPGN).\n   4. NYHA III\u002FIV heart failure; severe cardiac disease within 12 months.\n   5. Severe CNS disease impairing compliance\u002Fassessments.\n   6. Malignancy history (except cured non-melanoma skin cancer\u002Fcarcinoma in situ, disease-free ≥3 years).\n   7. Primary immunodeficiency.\n   8. Uncontrolled infection (uncomplicated UTI\u002Fupper respiratory infection permitted).\n   9. Positive HIV; positive HCV (except undetectable RNA); positive syphilis.\n   10. Positive HBsAg; positive HBcAb (except undetectable HBV DNA).\n   11. Positive EBV\u002FCMV DNA\u002FIgM at screening.\n   12. Active\u002Frecurrent tuberculosis.\n   13. Prior CAR-T or genetically modified immune cell therapy.\n   14. Live attenuated vaccine within 4 weeks before enrollment.\n   15. Hypersensitivity to cell therapy product components.\n   16. Tacrolimus hypersensitivity or ≥Grade 3 toxicity requiring hospitalization.\n   17. Other clinical trial participation within 30 days before screening.\n   18. Pregnant\u002Fbreastfeeding; childbearing potential unwilling to use effective contraception.\n   19. Any other ineligible condition (investigator judgment).\n2. Exclusion Criteria for SLE\n\n   1. Active\u002Funstable neuropsychiatric SLE requiring intervention within 90 days.\n   2. Anti-BAFF\u002FAPRIL therapy within required washout period; multiple NSAIDs within 14 days; inability to hold NSAIDs; intra-articular glucocorticoids within 6 weeks; immunosuppressants exceeding dose limits; hydroxychloroquine dose adjustment within 8 weeks; ACEI\u002FARB\u002FSGLT2i adjustment within 4 weeks.\n3. Exclusion Criteria for AAV\n\n   1. Alveolar hemorrhage requiring invasive ventilation beyond screening.\n   2. Dialysis\u002Fplasmapheresis within 12 weeks.\n   3. Renal transplantation history.\n   4. Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.\n   5. High-dose IV glucocorticoids within 4 weeks.\n   6. Oral glucocorticoids \\>60mg prednisone equivalent daily for \\>6 weeks.\n   7. Specific immunosuppressants\u002Fbiologics within 4 weeks.\n   8. Concomitant strong CYP3A4 inducers.\n4. Exclusion Criteria for IIM\n\n   1. Severe rhabdomyolysis or CK ≥120×ULN at screening.\n   2. FVC ≤50% predicted or DLCO ≤40% predicted at screening.\n5. Exclusion Criteria for SSc\n\n   1. Significant respiratory disease other than ILD.\n   2. FVC \\\u003C50% or DLCO \\\u003C40% predicted at screening\u002Fbaseline.\n   3. Lung transplantation listing\u002Fexpected within 12 months.\n   4. Scleroderma renal crisis within 6 months.\n   5. Scleroderma-like disorders.\n   6. Prior chlorambucil, bone marrow transplantation, or total lymphoid irradiation.\n6. Exclusion Criteria for pSS\n\n   1. Active fibromyalgia interfering with assessment\u002Frequiring medication adjustment (stable permitted).\n   2. Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.\n   3. High-dose glucocorticoids (≥60mg\u002Fday) within 4 weeks.","70 Years",{"count":182,"type":21},30,[184],"EARLY_PHASE1","This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others.\n\nThe CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells\u002Fkg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.",[187,146,25,148,188],"SLE - Systemic Lupus Erythematosus","Sjögren Syndrome",[190],"CD19\u002FBCMA CAR-T","NOT_YET_RECRUITING","2026-05-12",{"date":194,"type":39},"2026-05-19",{"date":196,"type":21},"2026-04-30",{"date":198,"type":21},"2029-04-30",{"name":200,"class":201},"Nanjing Bioheng Biotech Co., Ltd.","INDUSTRY",2,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":209,"targetDuration":4,"studyType":59,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":47},"100558245","early-phase-1-clinical-study-on-targeted-cd19-or-cd19-bcma-car-t-therapy-for-autoimmune-diseases-100558245","NCT06548607","Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×10\\^9\u002FL, lymphocyte count \\>0.3×10\\^9\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after CAR-T reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of CAR-T and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":210,"type":21},20,[184],"This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.",[214,146,25,148,215,216],"SLE (Systemic Lupus)","Sjogren's Syndrome","Autoimmune Diseases","2026-03-04",{"date":219,"type":39},"2026-03-06",{"date":221,"type":39},"2024-09-14",{"date":223,"type":21},"2027-12-31",{"name":200,"class":201},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":232,"targetDuration":4,"studyType":59,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100616096","early-phase-1-clinical-study-of-bct301-cell-injection-therapy-for-refractory-autoimmune-diseases-100616096","NCT07301164","Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases","A Study of BCT301 (Anti-CD19 Chemically Induced Pluripotent Stem Cell (CiPSC)-Derived CAR-iT Cells) Therapy for Refractory Autoimmune Diseases","Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n1. Voluntarily sign the informed consent form.\n2. Male or female, aged 18-80 years (inclusive), with a body weight ≥40 kg.\n3. 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 treatment period and for at least 6 months after the end of the treatment. Female participants of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to enrollment and must not be breastfeeding.\n4. Participants currently receiving one or more of the following treatments at stable doses: glucocorticoids, antimalarials, immunosuppressants:\n\n   1. If the participant is receiving glucocorticoid therapy, the following conditions must be met: the maximum dose at screening and during the screening period is 30 mg\u002Fday of prednisone (or equivalent). The dose must have been stable for ≥7 days prior to screening, and adjustments during the screening period must not exceed 5 mg\u002Fday of prednisone (or equivalent);\n   2. If the participant is receiving antimalarials and\u002For conventional immunosuppressants: the treatment must have been initiated ≥12 weeks prior to screening. The dose must have been stable for ≥8 weeks prior to screening and remain stable during the screening period;\n   3. If biological agents (belimumab, telitacicept, rituximab, etc.) were used prior to the screening period, a washout period of at least 5 half-lives must be completed before screening.\n5. Peripheral blood B cells must show positive CD19 expression as detected by flow cytometry.\n\nDisease-Specific Inclusion Criteria\n\n1\\. Systemic Lupus Erythematosus (SLE)\n\n1. Meet the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE.\n2. Have moderate to severe disease activity at screening, with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score \\>6.\n3. Have inadequate response to conventional therapy or experience disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n4. Have positive serological autoantibody tests: positive antinuclear antibodies (ANAs) and\u002For anti-ds-DNA antibodies and\u002For anti-Sm antibodies.\n\n2\\. Systemic Sclerosis (SSc)\n\n1. Meet the 2013 EULAR\u002FACR classification criteria for SSc.\n2. Fulfill either (a) or (b) below:\n\n   1. Inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n   2. Disease progression: skin progression with a modified Rodnan Skin Score (mRSS) ≥10; and\u002For interstitial lung disease evidenced by ground-glass opacities on high-resolution computed tomography (HRCT); a decline in forced vital capacity (FVC) ≥10%, or a decline in FVC ≥5% accompanied by a decline in diffusing capacity for carbon monoxide (DLCO) ≥15%.\n3. Have positive SSc-related autoantibodies. 3. Antiphospholipid Syndrome (APS)\n\n1\\) Meet the 2006 Sydney criteria for primary antiphospholipid syndrome. 2) Have medium to high titers of antiphospholipid antibodies (lupus anticoagulant \\[LA\\], anti-β2-glycoprotein 1 \\[β2GP1\\] IgG\u002FIgM, or anti-cardiolipin \\[aCL\\] IgG\u002FIgM); 3) Fulfill either (a) or (b) below:\n\n1. Receiving standard treatment with warfarin or alternative vitamin K antagonists (maintaining target international normalized ratio \\[INR\\]), or standard therapeutic doses of low molecular weight heparin (LMWH), and\u002For glucocorticoids and immunosuppressants\u002Fbiologics (e.g., cyclophosphamide, cyclosporine, tacrolimus, rituximab, etc.).\n2. Meet all four criteria for catastrophic APS:\n\ni) Involvement of three or more organs, systems, and\u002For tissues; ii) Development of manifestations within one week; iii) Histopathological confirmation of small vessel occlusion in at least one organ or tissue; iv) Positive antiphospholipid antibodies (aPL).\n\n4\\. Inflammatory Myopathy (IM)\n\n1. Meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including dermatomyositis, polymyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy).\n2. Have positive myositis-specific autoantibodies.\n3. For participants with muscle involvement: a Manual Muscle Test-8 (MMT-8) score \\\u003C142, and at least two of the following five core abnormalities: Physician Global Assessment ≥2, Patient Global Assessment ≥2, or extramuscular disease activity score ≥2; Health Assessment Questionnaire (HAQ) total score ≥0.25; muscle enzyme levels ≥1.5 times the upper limit of normal; or MMT-8 ≥142 but with active interstitial lung disease (ground-glass opacities on HRCT).\n\n5\\. Sjögren's Syndrome (SS)\n\n1. Meet the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome.\n2. Have a EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5.\n3. Have positive anti-SSA\u002FRo antibodies.\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\n6\\. Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)\n\n1. Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis (AAV), including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Have a history of or currently positive ANCA.\n3. Have a Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63).\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\nExclusion Criteria:\n\nStudy participants who meet any of the following criteria will be excluded from the study:\n\n1. Any medical condition that, in the opinion of the investigator, would contraindicate participation in the study, such as a life-threatening illness.\n2. Decreased organ function reserve not attributable to the primary disease:\n\n   a) Neutrophil count \\\u003C1×10⁹\u002FL; lymphocyte count \\\u003C0.3×10⁹\u002FL; hemoglobin \\\u003C70 g\u002FL; platelet count \\\u003C50×10⁹\u002FL; b) Alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN); aspartate aminotransferase (AST) \\>3 × ULN; total bilirubin \\>2 × ULN; c) Creatinine clearance \\\u003C40 mL\u002Fmin; estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²; or serum creatinine \\>2.5 mg\u002FdL; d) Left ventricular ejection fraction (LVEF) \\\u003C45% as measured by echocardiography; e) Oxygen saturation \\\u003C92% on room air.\n3. History of alcohol or substance abuse within the past 24 weeks.\n4. History of malignancy other than B-cell lymphoma.\n5. Presence of infections including human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency, syphilis, chronic hepatitis B or C, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n6. Known active tuberculosis (TB) infection or active bacterial infection.\n7. History of myocardial infarction, coronary angioplasty or stenting, unstable angina, clinically significant arrhythmia, or other clinically significant cardiac disease within 6 months prior to screening.\n8. Symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening, except in cases of antiphospholipid syndrome (APS).\n9. History of severe allergic reaction to any component of cellular therapy or other immunotherapeutic agents.\n10. Prior organ transplant requiring ongoing immunosuppressive therapy.\n11. Concurrent participation in another clinical trial that may interfere with disease assessment or study treatment.\n12. Prior treatment with CD19- and\u002For BCMA-targeted therapy or any CAR-T cell product; except in cases where prior therapy is deemed to have clearly failed (e.g., no response, short duration of response, or disease progression) as assessed by the investigator, the current disease state warrants the study treatment, and there is no clear evidence that toxicity from prior therapy would compromise the safety of the current study.\n13. Severe psychiatric disorder or significant cognitive impairment.\n14. Pregnancy, lactation, or planned pregnancy.\n15. Any other condition that, in the judgment of the investigator, would make the participant unsuitable for enrollment in this clinical trial.",{"count":233,"type":21},10,[184],"This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.",[237,238,239,240,25,241],"System Lupus Erythematosus","Systemic Sclerosis (SSc)","Inflammatory Myositis","Antiphospholipid Syndrome","Sjogren Syndrome","2025-12-09",{"date":244,"type":39},"2025-12-24",{"date":246,"type":21},"2025-12-11",{"date":248,"type":21},"2028-12-31",{"name":250,"class":46},"Peking University Third Hospital",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":47},"100612253","characterization-of-autoreactive-b-lymphocytes-in-autoimmune-diseases-and-immune-deficiencies-100612253","NCT07251179","Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies","AutoB-Tetramer","Inclusion Criteria:\n\n* Patients aged between 18 and 70\n* Patients for whom at least one of the following conditions has been confirmed:\n* Systemic lupus erythematosus meeting the 2019 ACR\u002FEULAR classification criteria.\n* Systemic scleroderma meeting the 2013 ACR\u002FEULAR classification criteria. ANCA-associated vasculitis according to the 2022 EULAR\u002FACR classification criteria.\n* Antiphospholipid syndrome according to the 2023 ACR\u002FEULAR criteria.\n* Primary immunodeficiencies according to IUIS criteria.\n* Patients capable of understanding the objectives of the research.\n* Patients affiliated with a social security health insurance scheme (beneficiary or dependant).\n* Patients who have signed and dated the informed consent form for non-identifying genetic testing.\n\nExclusion Criteria:\n\n* Patient refusing to participate in the study\n* Patient in a period of exclusion (determined by a previous or ongoing study) Inability to provide the subject with informed consent (in an emergency or immediate life-threatening situation, difficulties in understanding the subject, etc.)\n* Patient under legal protection\n* Patient under guardianship or conservatorship",{"count":259,"type":21},200,"Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase. Many AIDs are linked to the emergence of autoreactive B cells (BCs) directed against components of the self. In healthy individuals, these autoreactive B cells are counter-selected or regulated before reaching the antibody-secreting cell compartment. However, in predisposed individuals, a breakdown in B cell tolerance can occur, leading to the formation of autoantibodies with devastating consequences, such as the emergence of systemic lupus erythematosus (SLE), rheumatoid arthritis, and vasculitis. B-cell depletion is often beneficial in these patients, but paradoxically, therapies targeting B cells are not always effective. Furthermore, B cell depletion via LB-specific antibodies (anti-CD20) or treatment with CD19 chimeric antigen receptor T cells (CAR T) leads to complete and prolonged depression of the entire B compartment without targeting the LB population responsible for the onset of the disease. To date, two pitfalls in studies of human autoreactive LBs often complicate the interpretation of results:\n\ni) the difficulty of identifying autoreactive LBs among all LBs, ii) demonstrating the pathogenicity of autoreactive B lymphocytes when they can be identified individually. We propose to quantify and phenotype these autoreactive\u002Fpathogenic B cells using high-throughput flow cytometry in several clinical situations.",[147,262,92,240,263],"Systemic Scleroderma","Primary Immunodeficiencies","2025-11-26",{"date":266,"type":39},"2025-12-04",{"date":268,"type":21},"2026-01-01",{"date":270,"type":21},"2031-12-31",{"name":272,"class":46},"University Hospital, Strasbourg, France",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":282,"studyType":22,"phases":4,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":47},"100604592","68ga-fapi-petct-in-patients-with-anca-associated-vasculitis-100604592","NCT07151521","(68)Ga-FAPI PET\u002FCT in Patients With ANCA-associated Vasculitis","Application Value of Novel PET Tracers Targeting CAF in ANCA-Associated Vasculitis","GFPIPWAAV","Inclusion Criteria:\n\n1. Age over 18 years;\n2. Meeting the 2022 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) classification criteria for ANCA-associated vasculitis;\n3. Diagnosed with concomitant interstitial lung disease based on High-Resolution Computed Tomography (HRCT) images obtained within one year prior to enrollment, interpreted by two radiologists blinded to clinical information;\n4. Complete clinical information available;\n5. Signed and dated informed consent form;\n6. Willingness to comply with the study procedures and cooperate throughout the entire study process.\n\nExclusion Criteria:\n\n1. Presence of other rheumatic diseases;\n2. Presence of other conditions that may cause interstitial lung disease or renal impairment, such as systemic lupus erythematosus, dermatomyositis, or rheumatoid arthritis;\n3. History of, or planned, hematopoietic stem cell transplantation;\n4. Presence of severe comorbidities deemed by the investigators to be unsuitable for participation in this clinical study, such as severe cardiopulmonary insufficiency, severe bone marrow suppression, or severe hepatic or renal insufficiency;\n5. Acute abdominal emergencies such as intestinal perforation or complete intestinal obstruction;\n6. Pregnant or potentially pregnant women, and lactating women;\n7. Poor treatment compliance.",{"count":182,"type":21},"6 Months","Pulmonary and renal involvement are the most common clinical manifestations of antineutrophil cytoplasmic antibody(ANCA)-associated vasculitis (AAV). Studies have shown that both interstitial lung disease (ILD) and renal dysfunction are closely associated with poor prognosis in patients with AAV. Therefore, early identification of whether AAV patients have concomitant ILD and renal involvement is of great clinical importance for assessing disease severity, stratifying prognostic risk, and developing individualized treatment strategies.\n\nPositron emission tomography (PET) is a noninvasive molecular imaging technique that can provide decision-making support for early and accurate diagnosis, timely intervention, as well as evaluation of treatment response and prognosis. In the same individual, PET enables whole-body localization of disease in a single examination, overcoming the limitation of conventional diagnostic methods that typically assess only one region at a time, thereby facilitating patient benefit.\n\nIn recent years, many novel PET tracers have been developed and introduced into clinical practice. 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) has been studied in the diagnosis of various malignant and nonmalignant diseases; it targets fibroblast activation protein (FAP) and thus reflects the distribution of cancer-associated fibroblasts (CAFs). However, its clinical significance in AAV remains to be further investigated. This study aims to use a CAF-targeted novel PET tracer to conveniently and noninvasively detect the real-time distribution of lesions in patients, providing valuable information for personalized diagnosis and treatment.",[92],[286,287,288,289,290],"ANCA-associated vasculitis","FAPI","PET\u002FCT","ILD","Kidney","2025-11-13",{"date":293,"type":39},"2025-11-17",{"date":295,"type":39},"2025-09-01",{"date":297,"type":21},"2028-07-01",{"name":299,"class":46},"Ruijin Hospital",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":59,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":47},"100608580","early-phase-1-a-study-of-anti-cd19bcma-universal-car-t-cell-therapy-rd06-05-in-patients-with-autoimmune-diseases-100608580","NCT07203404","A Study of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Aged ≥18 years and ≤75 years.\n3. Adequate organ function defined as:\n\n   1. Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500\u002FμL, absolute lymphocyte count (ALC) ≥100\u002FμL, hemoglobin (Hb) ≥80 g\u002FL, and platelet count (PLT) ≥50,000\u002FμL. Transfusions and growth factors must not have been used within 7 days prior to screening to meet these criteria.\n   2. Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), and total bilirubin \\\u003C1.5 × ULN (or \\\u003C3.0 × ULN for subjects with Gilbert's syndrome).\n   3. Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.\n   4. Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).\n4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test. Females who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.\n5. From the time of signing the informed consent form until 6 months after the completion of RD06-05 infusion, female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective methods of contraception.\n\nInclusion Criteria for Subjects with Anti-GBM Disease:\n\nDiagnosis of anti-GBM disease according to the 2012 Chapel Hill Consensus Conference definitions, meeting both of the following criteria:\n\n1. Positive for anti-GBM antibody (based on historical or screening test results);\n2. Evidence of renal involvement at screening, defined as:\n\n   1. Presence of active, pathologically confirmed anti-GBM disease (renal biopsy must have been performed within 1 year prior to the screening visit or during the screening period); and\n   2. Accompanied by proteinuria and hematuria.\n\nInclusion Criteria for Subjects with SLE\u002FLN:\n\n1. Diagnosis of SLE according to the 2019 European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.\n2. Positive for antinuclear antibody (ANA), and\u002For anti-double-stranded DNA (anti-dsDNA) antibody, and\u002For anti-Smith (anti-Sm) antibody at screening.\n3. SLEDAI-2K score \\> 6 points at screening.\n\nInclusion Criteria for Subjects with AAV\u002FAAGN:\n\n1. Diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis.\n2. Positive for anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody at screening or based on historical testing.\n3. For AAV without renal involvement: A Birmingham Vasculitis Activity Score (BVAS) version 3 score of ≥3 at screening, indicating active vasculitis.\n\nInclusion Criteria for Subjects with MN:\n\n1. Diagnosis of primary (idiopathic) membranous nephropathy confirmed by renal biopsy pathology (the renal biopsy must have been performed within 2 years prior to screening or during the screening period).\n2. Meeting the criteria for high-risk or relapsed\u002Frefractory membranous nephropathy:\n\nHigh-risk patients, defined as meeting any of the following criteria:\n\n1. Normal eGFR with urine protein \\>3.5g\u002F24h, a reduction of \\\u003C50% in urine protein after 6 months of ACEI\u002FARB treatment, and serum albumin \\\u003C25 g\u002FL or anti-PLA2R antibody \\>50 RU\u002FmL;\n2. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² and\u002For urine protein \\>8g\u002F24h for more than 6 months.\n\nRefractory\u002FRelapsed patients:\n\nRefractory patients are defined as those resistant to prior immunosuppressive therapy (persistent urine protein ≥3.5g\u002F24h with a \\\u003C50% reduction from baseline).\n\nRelapsed patients are defined as those who achieved complete or partial remission with prior immunosuppressive therapy but subsequently developed recurrent urine protein ≥3.5g\u002F24h.\n\nInclusion Criteria for Subjects with SSC:\n\n1. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria.\n2. Diagnosis of diffuse cutaneous SSc at screening.\n\nInclusion Criteria for Subjects with IIM:\n\n1.Diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, corresponding to a probability score of ≥55%). The subtypes include dermatomyositis (DM), anti-synthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).\n\nExclusion Criteria:\n\n1. Subjects with SLE\u002FLN:\n\n   1. Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs\u002Fsymptoms associated with neuropsychiatric lupus, as assessed by a qualified specialist during screening.\n   2. Drug-induced or secondary lupus.\n2. Subjects with AAV\u002FAAGN:\n\n   1. Drug-induced or secondary AAV\u002FAAGN.\n   2. Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.\n3. Subjects with Anti-GBM Disease:\n\n   1. Anuria for more than 7 days.\n   2. Dialysis dependence for more than 30 days.\n   3. Ongoing moderate or severe pulmonary hemorrhage (or cessation within the past two weeks) defined as pulmonary hemorrhage requiring assisted ventilation, supplemental oxygen, or blood transfusion.\n   4. Symptomatic congestive heart failure (NYHA Class 2-4) requiring prescription medication or clinically significant cardiogenic peripheral edema.\n4. Subjects with MN:\n\n   Secondary membranous nephropathy.\n5. Subjects with IIM:\n\n   Presence of severe rhabdomyolysis or CK level ≥120 × ULN at screening.\n6. Subjects with SSc:\n\n   1. History of scleroderma renal crisis within 1 year prior to screening.\n   2. History of cardiac tamponade within 6 months prior to screening.\n   3. Active infection of digital ulcers within 3 months prior to screening.\n   4. Presence of digital gangrene at screening.","75 Years",{"count":309,"type":21},84,[184],"An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19\u002FBCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE\u002FLN, AAV\u002FAAGN, Anti-GBM, MN, SSc, and IIM).",[313,314,25,315,316,317,318,319],"SLE","LN","ANCA-Associated Glomerulonephritis","Anti-GBM Disease","MN","SSc","IIM","2025-09-23",{"date":322,"type":39},"2025-10-02",{"date":324,"type":39},"2025-07-24",{"date":326,"type":21},"2028-07-23",{"name":200,"class":201},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":59,"phases":337,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":350,"locationsCount":47},"100538011","phase-1-the-bcmacd19-dual-targeted-car-t-cell-in-participants-with-autoimmune-kidney-diseases-100538011","NCT06285279","The BCMA\u002FCD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases","Evaluation of the Safety and Efficacy of the BCMA\u002FCD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases: A Single-center Exploratory Clinical Study","Inclusion Criteria:\n\n1. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study.\n2. Participants must be aged ≥18 and ≤65 years.\n3. Disease-specific inclusion criteria:\n\n   Active, relapsing, refractory Lupus Nephritis (LN):\n\n   LN diagnosed by kidney biopsy within the last 2 years, with pathological types III, IV, or V, and a chronicity index (CI) score≤3\n\n   Meets one of the following criteria:\n\n   Refractory LN, defined as no remission after at least one standard regimen (CTX and\u002For MMF) for 6 months.\n\n   Relapsing LN, defined as a need to increase steroid dosage to control disease activity during maintenance treatment.\n\n   Clinical criteria: eGFR \\> 45 ml\u002Fmin\u002F1.73 m²; urinary protein quantification ≥ 1.5g\u002F24h; SLE-DAI score ≥ 8.\n\n   ANCA-associated vasculitis (AAV) patients:\n\n   Diagnosed as AAV according to the 2012 Chapel Hill Consensus Conference criteria, meeting one of the following:\n\n   Newly diagnosed AAV with renal involvement:\n\n   Renal involvement must meet both:\n\n   Kidney biopsy showing pauci-immune necrotizing glomerulonephritis. Urinary red blood cells \\>30\u002Fhigh power field.\n\n   Relapsing or refractory AAV:\n\n   Relapse: Defined as an increase in BVAS V3.0 score of ≥1 after remission, requiring adjustment of immunosuppressive treatment to regain remission.\n\n   Refractory: Defined as a) less than 50% reduction in BVAS V3.0 after 6 weeks of standard induction treatment; or b) persistent disease activity (BVAS V3.0 ≥3) after 12 weeks of treatment.\n\n   Membranous nephropathy (MN) patients:\n\n   Tissue biopsy diagnosed as aPLA2R-related membranous nephropathy.\n\n   Clinical criteria for high-risk or relapsing\u002Frefractory membranous nephropathy:\n\n   High-risk patients:\n\n   Defined as meeting any of the following: eGFR normal, urinary protein \\>3.5g\u002Fd, ACEI\u002FARB treatment for 6 months with \\\u003C50% reduction in urinary protein, combined with serum albumin \\\u003C25g\u002Fl or aPLA2R \\>50RU\u002Fml; or eGFR \\\u003C60ml\u002Fmin\u002F1.73m², and\u002For urinary protein \\>8g\u002Fd for over 6 months.\n\n   Refractory\u002Frelapsing membranous nephropathy patients:\n\n   Refractory: Defined as resistance to previous immunosuppressive treatment (persistent urinary protein ≥3.5g\u002Fd with \\\u003C50% reduction compared to baseline).\n\n   Relapse: Defined as complete or partial remission achieved with previous immunosuppressive treatment, followed by reappearance of urinary protein ≥3.5g\u002Fd.\n\n   eGFR ≥ 45 ml\u002Fmin\u002F1.73 m².\n\n   IgG4-related disease patients:\n\n   Meeting the 2019 ACR\u002FEULAR diagnostic criteria for IgG4-related disease, and meeting one of the following:\n\n   Newly diagnosed active IgG4-related disease (Respond Index (RI) ≥3).\n\n   Refractory or relapsed IgG4-related disease:\n\n   Refractory: Defined as no remission with steroid or steroid plus immunosuppressant treatment (no clinical or imaging improvement, RI decrease \\\u003C2) Relapse: Defined as new progression or recurrence of clinical symptoms or imaging findings in a patient who had achieved remission, with or without elevated blood IgG4 (RI increase≥2)\n4. Expected survival ≥ 12 weeks.\n5. ECOG performance status ≤ 2.\n6. Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of \\\u003C1% per year.\n7. Participants must have adequate organ function, meeting all of the following criteria before enrollment:\n\n   1. Absolute neutrophil count ≥ 1.0×10⁹\u002FL \\[Granulocyte colony-stimulating factor (G-CSF) support is allowed, but no supportive treatment should be received within 7 days before the assessment\\].\n   2. Platelet count ≥ 50×10⁹\u002FL \\[No transfusion support (including component transfusion) or treatments aimed\n\nExclusion Criteria:\n\n1. Participants who have received the following previous treatments:\n\n   1.1 Participants who have received gene therapy before enrollment. 1.2 Participants who have been injected with live vaccines within 4 weeks prior to enrollment.\n\n   1.3 Participants who have received other investigational drug treatments within 12 weeks before apheresis.\n2. Participants with active malignancies within the past 5 years, except for tumors deemed curable and cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.\n3. Participants who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA tests (defined as HBV DNA quantification above the lower limit of detection or above the normal reference range of the testing center, or qualitative HBV DNA test positive); positive for Hepatitis C virus (HCV) antibodies with positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis test RPR.\n4. Participants with uncontrolled active infections (except for \\\u003C Grade 2 CTCAE urinary reproductive system infections and upper respiratory infections).\n5. Participants with severe heart diseases, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ III), severe arrhythmias.\n6. Participants with hypertension or diabetes that cannot be controlled with medication.\n7. Participants with unresolved toxic reactions from previous treatments to baseline or ≤ Grade 1 (according to NCI-CTCAE v5.0, except for alopecia and clinically insignificant lab abnormalities).\n8. Participants who have undergone major surgery within 2 weeks prior to enrollment or plan to have surgery during the waiting period for infusion or within 12 weeks after receiving study treatment (except for planned minor surgeries under local anesthesia).\n9. Participants with solid organ transplants.\n10. Pregnant or breastfeeding women.\n11. Participants with a history of central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, dementia, psychosis, etc.) or consciousness disorders.\n12. Participants with other unstable systemic diseases as judged by the researcher, including but not limited to severe diseases of the liver, kidneys, gastrointestinal tract, or metabolic diseases requiring medication.\n13. Participants are known to have life-threatening allergic reactions, hypersensitivity, or intolerance to FKC288 cellular products or their components.\n14. Participants judged by the researcher to have bleeding, severe thrombosis, or hereditary\u002Facquired bleeding and severe thrombosis conditions (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or patients currently undergoing thrombolytic or anticoagulant therapy.\n15. Participants who have received any B cell-depleting therapy or non-depleting B cell targeted therapy within 6 months.\n16. Participants who have received high-dose methylprednisolone treatment (cumulative dose \\> 1.5g) or cyclophosphamide pulse therapy within a month.\n17. Participants judged by the researcher to be unable to discontinue other immunosuppressants one week before apheresis, or those treated with more than 5 mg\u002Fday of prednisone (or equivalent dose of other corticosteroids).\n18. AAV patients diagnosed with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) or with active alveolar hemorrhage.\n19. Other conditions deemed by the researcher as unsuitable for enrollment.","65 Years",{"count":5,"type":21},[338],"PHASE1","This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\\^6 cells\u002Fkg, 1.0×10\\^6 cells\u002Fkg, 3.0×10\\^6 cells\u002Fkg, and an alternative dose of 0.1×10\\^6 cells\u002Fkg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).",[341,92,342,343],"Lupus Nephritis","Membranous Nephropathy - PLA2R Induced","IgG4-Related Diseases","2025-06-06",{"date":346,"type":39},"2025-06-11",{"date":348,"type":39},"2024-03-04",{"date":248,"type":21},{"name":351,"class":46},"Nanjing University School of Medicine",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":359,"targetDuration":4,"studyType":59,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":47},"100591868","early-phase-1-clinical-study-on-the-targeted-cd19-universal-car-t-cell-injection-rd06-04-for-the-treatment-of-iim-and-aav-100591868","NCT06986018","Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of IIM and AAV","Clinical Study on the Safety, Efficacy, and Pharmacokinetics of a Universal CD19-Targeted CAR-T Cell Injection (RD06-04) in the Treatment of Patients With Refractory Inflammatory Myopathy and ANCA-Associated Vasculitis","General Inclusion Criteria:\n\n1. The subject voluntarily participates in this trial and has signed the informed consent form.\n2. Age ≥18 years and ≤70 years, regardless of gender.\n3. Organ Function and Laboratory Tests:\n\n   1. Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except for Gilbert syndrome).\n   2. Renal Function: Creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood Routine: Neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60 g\u002FL, platelet count ≥50×10\\^9\u002FL, lymphocyte count \\>0.3×10\\^9\u002FL.\n   4. Coagulation Function: International normalized ratio (INR) ≤1.5×ULN, or prothrombin time (PT) ≤1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest while breathing room air.\n   6. Echocardiography shows left ventricular ejection fraction (LVEF) ≥50%.\n4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test result during screening.\n5. Females of childbearing potential must agree to use highly effective contraception from at least 28 days before the start of lymphodepletion until 12 months after the infusion of RD06-04. Males of reproductive potential must agree to use an effective barrier method of contraception from the start of lymphodepletion until 12 months after the infusion of RD06-04 and must not donate semen or sperm during the entire trial period.\n\nFor IIM participants:\n\n1\\. Diagnosed with IIM (including probable or definite diagnosis, i.e., a probability of ≥55%) according to the 2017 ACR\u002FEULAR classification criteria. Currently, the ENMC considers that the subtypes of IIM mainly include dermatomyositis (DM), antisynthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).\n\nFor AAV participants:\n\n1\\. Meets the diagnostic criteria for ANCA-associated vasculitis as established by the 2022 ACR\u002FEULAR, including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), and eosinophilic granulomatosis with polyangiitis (EGPA).\n\nExclusion Criteria:\n\n1. As determined by the investigator, the primary diagnosis is a rheumatic autoimmune disease other than the disease under study, which the investigator believes may confound the efficacy evaluation of the study disease.\n2. Clinically significant central nervous system disease or pathological changes not caused by the non-study disease within 12 months prior to screening.\n3. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (such as kidney, lung, heart, liver) or plans for such transplantation in the future.\n4. For IIM patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n5. History of, or current significant cardiovascular dysfunction.\n6. History of malignancy within 5 years prior to signing the ICF.\n7. Pregnant or breastfeeding women.\n8. History of recurrent infections requiring hospitalization and intravenous antibiotics (e.g., three or more episodes of the same type of infection within the past year).\n9. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n10. History of drug or alcohol abuse within 1 year prior to screening.\n11. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":360,"type":21},12,[184],"This is an open-label, investigator-initiated clinical trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with refractory IIM and AAV. The study plans to enroll a total of 12 participants, with 6 cases each for IIM and AAV. Enrollment for both diseases will proceed in parallel. The dose will be 6×10\\^6 CAR+T cells\u002Fkg (±30%), and patients will receive a single infusion of RD06-04.",[148,117],[365],"CD19-Targeted Universal CAR-T","2025-05-15",{"date":368,"type":39},"2025-05-22",{"date":370,"type":21},"2025-06-14",{"date":372,"type":21},"2026-12-31",{"name":374,"class":46},"Peking University People's Hospital",{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":59,"phases":384,"briefSummary":385,"conditions":386,"keywords":391,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":400,"locationsCount":47},"100591308","phase-1-ucar-t-cell-therapy-targeting-cd19-bcma-in-patients-with-relapse-refractory-autoimmune-diseases-100591308","NCT06978738","UCAR T-cell Therapy Targeting CD19\u002F BCMA in Patients With Relapse\u002F Refractory 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\n* 1.Age ≥ 18 years old (inclusive), regardless of gender.\n* 2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.\n* 3.Functional requirements for major organs are as follows:\n\n  1. Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 \\^ 9\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g\u002FL; C. Platelets ≥ 30 × 10 \\^ 9\u002FL.\n  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≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);\n  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);\n* 4.ECOG score 0-1.\n* 5.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.\n* 6.Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n* 7.Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.\n\nExclusion Criteria:\n\n* 1.Subjects with a history of severe drug allergies or allergic constitutions;\n* 2\\. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;\n* 3\\. Subjects with insufficient cardiac function;\n* 4\\. Subjects with congenital immunoglobulin deficiencies;\n* 5\\. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.\n* 6\\. 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;\n* 7\\. Subjects with mental illness and severe cognitive dysfunction;\n* 8\\. Pregnant women or women planning to conceive;\n* 9.Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":383,"type":21},18,[338],"This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19\u002FBCMA CAR T-cells in With Relapse\u002FRefractory Autoimmune Diseases.",[147,387,388,146,117,389,390],"Autoimmune Hemolytic Anemia","Myasthenia Gravis","Inflammatory Myopathy","IgG4-RD",[392,393],"Universal Allogeneic CAR T-cells","CD19\u002FBCMA CAR T-cells","2025-05-11",{"date":396,"type":39},"2025-05-18",{"date":398,"type":21},"2025-05",{"date":74,"type":21},{"name":401,"class":46},"Changzhou No.2 People's Hospital",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":335,"enrollmentInfo":409,"targetDuration":4,"studyType":59,"phases":411,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":47},"100568731","phase-1-anti-cd19-car-t-cell-therapy-in-refractory-systemic-autoimmune-diseases-100568731","NCT06685042","Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases","CATARSIS","Inclusion criteria\n\n* General\n\n  1. Subjects must understand and voluntarily sign an informed consent form, including written consent for data protection;\n  2. Adults aged ≥ 18 years and \\\u003C 65 years at time of consent;\n  3. Male subjects, unless surgically sterile, must agree to use two acceptable methods for contraception (e.g., spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the Informed Consent Form (ICF) until 12 months after dosing of the IMP;\n  4. Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl index \\\u003C1) starting from the time of signing the ICF and for 12 months after dosing of the IMP;\n  5. Must be able to adhere to the study visit schedule and other protocol requirements;\n  6. Double vaccination (2 doses) against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.\n* SLE subjects\n\n  a) Fulfilling the 2019 ACR\u002FEULAR classification criteria of SLE; b) Presence of anti-dsDNA, anti-histone, anti-nucleosome or anti-Sm antibodies; c) Active disease at screening, defined as ≥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); d) Insufficient response to glucocorticoids and at least 2 of the following treatments: hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, rituximab.\n* SSc subjects\n\n  1. Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc;\n  2. Diffuse SSc with respective autoantibody profile;\n  3. Signs for fast progression including i) disease duration ≤5 years (from onset of first non-Raynaud manifestation), ii) mRSS score 10-35 at screening, iii) elevated acute phase reactant levels (CRP ≥ 6 mg\u002FL, ESR ≥ 28mm\u002Fh or platelet count ≥ 330 000\u002Fmm3), iii) mRSS increase ≥ 3 units or involvement of one new body area or mRSS increase ≥ 2 units in one body area or ≥1 tendon friction rub over 6 months;\n  4. Insufficient response to glucocorticoids and to at least 2 of the following treatments:\n\nmycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab.\n\n* DM\u002FPM subjects\n\n  a) Fulfilling the 2017 ACR\u002FEULAR classification criteria for probable or definite DM or PM57, b) Muscle weakness as defined by 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 \\>1.3 times upper limit of normal, VAS global extra muscular activity ≥ 2 cm; c) Presence of at least one myositis-specific antibody; d) Insufficient response to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, and intravenous immunoglobulins.\n* AAV subjects\n\n  1. Fulfilling the 2022 ACR\u002FEULAR classification criteria for MPA\u002FGPA\u002FEGPA,\n  2. Presence of ANCA to either proteinase 3 or myeloperoxidase;\n  3. At least one major or three non-major items or at least two renal items of hematuria and proteinuria on the BVAS;\n  4. Failure of at least 1 of the following treatments: glucocorticoids, cyclophosphamide, or B-cell targeting therapy.\n\nExclusion criteria\n\n* Clinically suitability for a less burdensome and\u002For approved therapeutic approach, as judged by the investigator;\n* ANC \\\u003C 1.000\u002Fmm3, ALC \\\u003C 500\u002Fmm3 or hemoglobin \\\u003C 8 g\u002Fdl, absolute CD3+ T cell count ≤100\u002Fµl;\n* Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.\n* Relevant cardiovascular disease: recent history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, significant arrhythmia, congestive heart failure, or left ventricular ejection fraction \\\u003C 50%, as determined by echocardiography\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study;\n* Impaired renal function, i.e., eGFR \\\u003C 30 ml\u002Fmin;\n* Patients with evidence on thorax CT of advanced fibrotic interstitial lung disease and whose latest pulmonary function test showed a Forced Vital Capacity (FVC) \\\u003C 40% of predicted or a Diffusing Capacity for Carbon Monoxide (DLCO) \\\u003C 30% of predicted\n* Any concomitant severe active infection, including HIV (even with negative viral load), active hepatitis B (either positive for Hepatitis B core antibody \\[HBcAb\\] or positive hepatitis B surface antigen \\[HBsAg\\] and NAT tests) and\u002For C (\\\u003C12 weeks between achievement of a sustained virological response to the specific treatment and apheresis) according to the American Association for the Study of Liver Diseases guidelines, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If the presence of latent tuberculosis is established, then treatment according to local guidelines must have been initiated before enrolment;\n* Pregnant or lactating females;\n* Known hypersensitivity to either any drug components or any auxiliary medicinal products scheduled during trial participation, including during lymphodepletion;\n* Malignancy in the last 5 years before screening. The inclusion of patients with previously completely resected carcinoma in situ who have not required treatment other than surgery is allowed.\n* Previous CAR T cell administration;\n* A therapeutic schedule not compatible with the wash-out requirements for the leukapheresis procedure (section 5.8.1 of CSP) and the medications permitted during the study (section 7.11 of CSP);\n* Concurrent treatment with other investigational agents or participation in other investigational trials.\n* Treatment, as part of an investigational clinical trial, with an experimental product with a definite or potential effect on T or B-cells in the previous 2 years.\n* Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis;\n* Subjects who are younger than 18 years or are incapable of understanding the aim, importance, and consequences of the study and giving legal informed consent;\n* Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration or may interfere with the interpretation of results;\n* Subjects who possibly are dependent on the Sponsor, the Principal Investigator, or the Investigator (e.g., family members).\n* Limited to patients diagnosed with SLE: patients with a history of severe central nervous system (CNS) involvement, including those who have presented aseptic meningitis, cerebral vasculitis, cerebrovascular disease, demyelinating syndrome, myelopathy, seizure disorder, status epilepticus, and severe lupus headache, will be excluded.\n* Patients meeting the classification criteria for multiple connective diseases such as overlapping SLE and Sjogren's Syndrome (SS) or SLE and Rheumatoid Arthritis (RA) and patients diagnosed with Mixed Connective Tissue Disease (MCTD).",{"count":410,"type":21},8,[338,412],"PHASE2","The CATARSIS study explores the use of anti-CD19 CAR T-cell therapy as a novel approach for treating refractory systemic autoimmune diseases, specifically SLE, SSc, DM\u002FPM, and AAV. These life-threatening conditions often resist current therapies, and B cells play a key role in their pathogenesis. The study employs CD19-CAR\\_Lenti, an autologous CAR T-cell product targeting CD19-positive B cells, aiming to reduce inflammation and autoimmunity. This open-label, single-dose, phase I basket trial will assess the safety, feasibility, and preliminary efficacy of CAR T-cell therapy, focusing on adverse events, infection rates, and overall response at 24 weeks. Eight participants will be included.",[415,416,25,417,418],"Lupus Erythematosus, Systemic","System; Sclerosis","Dermatomyositis","Polymyositis","2025-04-10",{"date":421,"type":39},"2025-04-11",{"date":423,"type":39},"2024-11-29",{"date":425,"type":21},"2025-12",{"name":427,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":335,"enrollmentInfo":435,"targetDuration":4,"studyType":59,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":451,"locationsCount":47},"100577108","phase-2-bcma-cd19-car-t-therapy-for-refractory-autoimmune-diseases-100577108","NCT06794008","BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases","An Open, Single-Arm, Single-Center Clinical Study Assessing the Safety and Efficacy of BCMA-CD19 Targeted Chimeric Antigen Receptor T-Cell Therapy in Multiple Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age, 18-65 years old (inclusive), weight \\>=45kg, male and female;\n2. The diagnosis of each disease meets the following criteria:\n\nSystemic lupus erythematosus: 1997 ACR classification criteria or 2012 SLICC classification criteria Sjögren's syndrome: 2002 International Classification of Sjögren's Syndrome Inflammatory myopathies: 1977 Bohan Recommendation Systemic sclerosis: 1980 ACR classification criteria or 2013 ACR-EULAR classification criteria Behcet's disease: 1989 International Classification Criteria for Behcet's disease ANCA-associated vasculitis: 1990 ACR classification criteria IgG4-related disease: 2011 IgG4-RD composite diagnostic criteria Antiphospholipid syndrome: 2006 revision of the Sapporo APS classification criteria Acquired thrombotic thrombocytopenic purpura: consistent with a clinical diagnosis of TTP, including microscopic evidence of thrombocytopenia and red blood cell fragmentation (e.g., red blood cell fragmentation) 3. Multiple treatment regimens are ineffective or ineffective (including but not limited to high-dose glucocorticoids, adequate immunosuppressants and biologics) 4. Use of glucocorticoids (\\\u003C=1mg\u002Fkg\u002Fd prednisone or equivalent doses of other hormones), DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) must be on stable treatment for 4 weeks before receiving the first study drug, and no increase in hormone dose and other immunosuppressants throughout the study.\n\n5\\. Subjects voluntarily participate in this study and voluntarily sign the informed consent form; 6. Subjects who have the possibility of having children or whose partners have the possibility of having children must agree to use effective contraception throughout the study period (but cannot use oral estrogen, use estrogen vaginal ring, etc.) 7. Additional enrollment criteria for different diseases (related to the degree of disease activity):\n\n1. Patients with Behcet's disease must be active patients who meet the following conditions, and the active phase is defined as the emergence of new symptoms or the deterioration of existing symptoms, and one of the following conditions must be met:\n\n   A. Organ involvement: involvement of any major organ (e.g., ocular lesions, vascular lesions, central nervous system, gastrointestinal system); B. 100% increase in the number of oral or genital ulcers \\>=compared to the onset of oral\u002Fgenital ulcers compared to the first day; or an increase in the number of oral or genital ulcers by 3; C. Canker disease is at least 12 months; D. History of several oral ulcers per month E. Arthritis: \\>=50% increase in the number of swollen joints, or 3 more swollen joints; F. Skin lesions (non-oral\u002Fgenital ulcers): \\>= physician overall lesion score increased by \\>=50% or by two points in the total score.\n2. Patients with active inflammatory myopathy need to meet the following additional conditions:\n\n   Active myositis as defined by the Baseline Freehand Muscle Strength Test (MMT-8) of no more than 125\u002F150 and at least 2 additional CSMs that meet the criteria specified below:\n\n   a) Visual Analogue Scale\\[VAS\\] of patient global activity ≥2 cm, b) physician's global disease activity ≥2 cm, c) Health Assessment Questionnaire (HAQ) Disability Index ≥ 0.25 d) Elevation of at least one muscle enzyme \\[including creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), and aspartate aminotransferase (AST)\\] with a minimum level of 1.3 x upper limit of normal e) Global Extramuscular Disease Activity Score, with a minimum of 1.0 cm on a 10 cm VAS scale \\[This measure is a physician's comprehensive assessment based on the assessment of physique, skin, bone, gastrointestinal, lung, and cardiac activity scale activity scores using the Myositis Disease Activity Assessment Tool (MDAAT).\n\n   f) To ensure that we are able to recruit patients with active DM with severe rash who may not meet the MMT-8 criteria above, we recommend the use of additional inclusion criteria so that the International Myositis Assessment and Clinical Study (IMACS) Improved Definition (DOI) can be achieved: 1) MDAAT \\> on the 10 cm VAS scale 3 cm skin VAS score, and 2) at least 3 of the above 5 criteria.\n3. ANCA-associated vasculitis:\n\n   A. Comply with GPA\u002FMPA\u002FEGPA classification standards; B. Patients with severe vasculitis activity (meeting at least one of the following conditions);\n\n   a) Renal involvement is characterized by one of the following: i. Evidence of glomerulonephritis in any of the following situations: Renal biopsy shows focal necrotizing glomerulonephritis. Active urinary sediment characterized by glomerular hematuria and proteinuria ii. Patients with prior normal or no prior renal disease document, estimated glomerular filtration rate (eGFR) \\\u003C50 ml\u002Fmin\u002F1.73 m2, and prior chronic kidney disease (eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m2) showed a reduction in eGFR of at least 25% compared with the previous one.\n\n   b) Pulmonary hemorrhage due to active vasculitis satisfies all three of the following: i. Chest X-ray or CT scan showing diffuse pulmonary infiltrates ii. Pulmonary infiltrates that cannot be explained by other causes (e.g., volume overload or pulmonary infection) iii. At least one of the following: Evidence of alveolar hemorrhage on bronchoscopy or bloody bronchoalveolar lavage Hemoptysis was observed Unexplained anemia (\\\u003C10 g\u002FdL) or decreased hemoglobin (\\>1 g\u002FdL) and less than 10g\u002FdL Increased carbon dioxide dispersion\n4. Additional Enrollment Criteria for Systemic Sclerosis:\n\n   Subjects are at high risk of fatal outcomes based on the following prognostic factors: Subjects must have the following \"a\" , and at least one of \"b\" or \"c\".\n\n   a) Diffuse cutaneous scleroderma with an mRSS score of \\>=16, validated by the same physician at 2 different times \\>= 1 day apart and separated by \\\u003C 28 days.\n\n   b) Presence of SSc-related lung disease with FVC \\\u003C 70% or 70% predicted DLCO \\\u003C after hemoglobin correction and evidence of alveolitis obtained by high-resolution chest CT scan or PAL.\n\n   c) History of SSc-related nephropathy, no disease activity before enrollment screening. A history of hypertensive renal crisis with scleroderma is included in this criterion and is defined as follows: i. History of new-onset hypertension based on any of the following (must be repeated and confirmed at least 2 hours apart within 3 days of the first event) with change from baseline SBP\\>=140 mmHg DBP\\>=90 mmHg SBP rose by \\>=30 mmHg compared to baseline DBP increased by \\>=20 mmHg compared to baseline AND ii. One of the following 5 characteristics Serum creatinine increased \\>= \\>50% from baseline proteinuria: \\>=2+; Creatinine ratio \\> upper limit of normal Thrombocytopenia: \\\u003C100, 000 plts\u002Fmm3 Hemolysis: increased by blood smear or reticulocyte count\n5. Additional enrollment criteria for systemic lupus erythematosus A. The SLEDAI score of the patient before enrollment \\>= 7 points B. Failure to receive the following treatments: oral prednisone \\>=20 mg\u002Fd; Cyclophosphamide 0.4 to 0.6 g\u002Fm2 once every two weeks for 6 months, or other immunosuppressants such as mycophenolate mofetil 2 g\u002Fday for 3 months without remission.\n6. Additional enrollment criteria for antiphospholipid syndrome A. Cardiolipin antibody, lupus anticoagulant factor, and anti-β2-glycoprotein 1 antibody were all positive before enrollment.\n\n   B. History of thromboembolism or morbid pregnancy confirmed by clear objective evidence.\n7. Sjögren's disease additional enrollment criteria A. Positive anti-Ro\u002FSSA antibody screen. B. ESSDAI\\>= 6 POINTS\n8. Additional enrollment criteria for IgG4-related diseases (confirmed: A+ B+C) A. Clinical examination showing the presence of characteristic diffuse\u002Flocal swelling or masses in a single or multiple organs.\n\nB. Blood tests show elevated serum IgG4 concentration (135 mg\u002Fdl). C. Histopathological examination shows significant lymphocytic and plasmacytic infiltration and fibrosis or IgG4+ plasmacyte infiltration (IgG4+\u002FIgG+ cell ratio \\>40% and \\>10 IgG4+ plasma cells\u002FHPF).\n\nExclusion Criteria:\n\n1. Use of rituximab or other monoclonal antibodies within 1.6 months.\n2. Received high-dose glucocorticoids (\\>1 mg\u002Fkg\u002Fd) within 1 month.\n3. Serious complications: including heart failure (\\>= NYHA Class III), renal insufficiency (creatinine clearance \\\u003C=30 ml\u002Fmin), hepatic insufficiency (serum ALT or AST greater than three times the upper limit of normal, or total bilirubin greater than the upper limit of normal)\n4. Other severe, progressive, or uncontrollable hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral diseases (including demyelinating diseases such as multiple sclerosis).\n5. Known allergies, hyperreactivity, or intolerance to IL-2 or its excipients.\n6. Have a serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), or hospitalization for infection, or use of intravenous antibiotics for treatment of infection 2 months prior to the first dose of treatment.\n7. Chest imaging showing malignancy or current activity within 3 months prior to the first use of study drug Abnormalities in sexually transmitted infections (including tuberculosis).\n8. Infection with HIV (HIV antibody-positive serology) or hepatitis C (Hep C antibody-positive serology).\n\nIf seropositive, it is advisable to consult a physician with expertise in the treatment of HIV or hepatitis C virus infection.\n\n10\\. Any known malignancy or history of malignancy within the past 5 years (with the exception of non-melanoma skin cancer, non-melanoma skin cancer with no signs of recurrence or surgically cured cervical tumor within 3 months prior to the use of the first investigational agent).\n\n11\\. Have an uncontrolled mental or emotional disorder, including a history of drug and alcohol abuse within the past 3 years, which may preclude the successful completion of the study.\n\n12\\. Received or anticipated receipt of any live viral or bacterial vaccine injection within 3 months prior to the first injection of study dose, during the study, or within 4 months after the last injection of study dose. Bacillus Calmette-Guérin vaccination within 12 months of screening.\n\n13\\. Pregnant, lactating women (WCBP) who are unwilling to use medically approved contraception during treatment and for 12 months after the end of treatment.\n\n14\\. Males whose partner is of childbearing potential but who are unwilling to use appropriate medically approved contraception during treatment and for 12 months after the end of treatment.\n\n15\\. Patients with inflammatory myopathies should additionally exclude: 3) Adolescent DM or PM, myositis overlaps with another connective tissue disease, cancer-associated myositis, inclusion body myositis, or any other non-immune-mediated myopathy.\n\n4\\) Severe muscle impairment is defined as a baseline global muscle impairment score of MDI (Myositis Injury Index) \\>=5cm on 10 cm VAS.\n\n16\\. ANCA-associated vasculitis requires additional exceptions: positive anti-GBM antibodies.",{"count":436,"type":21},50,[412],"The objective of this study is to evaluate the efficacy and safety of BCMA\u002FCD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.",[147,389,238,92,343,240,440,151,241],"Acquired Thrombotic Thrombocytopenic Purpura",[442,443,444],"CAR-T","CD19","BCMA","2025-04-01",{"date":447,"type":39},"2025-04-02",{"date":449,"type":39},"2024-12-26",{"date":223,"type":21},{"name":374,"class":46},{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":462,"conditions":463,"keywords":464,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":475},"100508228","avacostar---pass-100508228","NCT05897684","Avacostar - (PASS)","Avacostar - A Post Authorization Safety Study (PASS) to Evaluate the Incidence of Safety Events of Interest in Patients Treated With Avacopan for ANCA-associated Vasculitis (AAV)","Avacostar","Inclusion Criteria:\n\n* Diagnosis of AAV (MPA or GPA), as determined by the Investigator according to their usual practice.\n* Active, severe AAV at the time of commencing avacopan or non-avacopan SoC induction therapy, in the opinion of the Investigator.\n* Age ≥18 years of either sex.\n* Has provided written informed consent.\n* Has commenced within the previous 6 months, or is planned to commence avacopan, cyclophosphamide or rituximab for the treatment of severe, active AAV outside of an interventional clinical study.\n\nExclusion Criteria:\n\n• Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.",{"count":461,"type":21},500,"The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years.",[92],[465],"anti-neutrophil cytoplasmic antibody (ANCA)-AAV","2025-01-29",{"date":468,"type":39},"2025-01-31",{"date":470,"type":39},"2023-09-11",{"date":472,"type":21},"2030-12-01",{"name":474,"class":201},"Vifor Fresenius Medical Care Renal Pharma",35,{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":16,"minAge":484,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":494,"locationsCount":47},"100577171","early-access-avacopan-in-real-world-anca-associated-vasculitis-100577171","NCT06794827","Early-access Avacopan in Real-world ANCA-associated Vasculitis","Evaluating Clinical Practice of Early Access Avacopan Treatment for ANCA-associated Vasculitis in European Countries","AVAC-EUR","Inclusion Criteria:\n\n* Established diagnosis of GPA or MPA\n* Treatment (initiation) with avacopan\n* Informed consent for use of medical data\n\nExclusion Criteria:\n\n* If there is no AAV disease activity present that can be supported by an objectifiable clinical measure or assessment\n* If a subject is below 16 years old","16 Years",{"count":87,"type":21},"The current study proposal aims to investigate the clinical practice variation of the initial use of avacopan for AAV patients in Europe. The study will describe patient characteristics and organ-specific clinical benefit of avacopan treatment in a unique, first-experience cohort of AAV patients. By studying the clinical practice variation of first-experience avacopan treatment, this study will be uniquely positioned to identify pivotal issues on the real-life implementation of avacopan treatment. These observational data can ultimately serve to address current knowledge gaps on avacopan treatment in AAV patients, improve the care and drug-access for AAV patients with avacopan treatment and generate new areas of research.",[25],"2025-01-22",{"date":490,"type":39},"2025-01-27",{"date":492,"type":39},"2023-11-01",{"date":372,"type":21},{"name":495,"class":46},"Leiden University Medical Center",{"id":497,"slug":498,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":506,"conditions":507,"keywords":509,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":47},"100551644","neutrophil-extracellular-traps-in-different-forms-of-systemic-sclerosis-100551644","NCT06462768","Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis","Neutrophil Extracellular Traps in Systemic Sclerosis","NETOSE","Inclusion Criteria:\n\n\\*For patients of group 1:\n\n* Patients with systemic sclerosis (ACR-EULAR Criteria)\n* Patients taking care of in internal medicine or in dermatology department's of the university hospital of Reims\n* Patients consenting to participate to the study\n* Patients enrolled in the national healthcare insurance program\n\nFor patients of group 2:\n\n* Patients with other connective tissue disease (ACR specific-disease criteria)\n* Patients taking care of in internal medicine or in dermatology department's of the university hospital of Reims\n* Patients consenting to participate to the study\n* Patients enrolled in the national healthcare insurance program\n\nFor patients of group 3 (healthy volunteers)\n\n* Patients eligible for blood donation (blood donation regulation criteria of January 11th 2022 decree)\n* Patients without medical history of autoimmune systemic or chronic inflammatory systemic disease,\n* Patients without current or past neoplasy disease,\n* Patients without chronic metabolic pathology\n* Patients without treatment by anti inflammatory or corticotherapy for the last 15 days,\n* Patients without infectious pathology or inflammatory acute for the last 15 days\n* Patients consenting to participate to the study\n\nExclusion Criteria for patients of all groups:\n\n* Patients\u002FHealthy volunteers under 18 years old\n* Patients\u002FHealthy volunteers protected by the law\n* Patients\u002FHealthy volunteers not consenting to participate to the study after information\n* Patients with inflammatory pathology or infectious acute intercurrent pathology in the last 15 days before inclusion\n* Pregnant or breastfeeding women",{"count":505,"type":21},260,"Systemic SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and\u002For fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve Reactive Oxygen Species (ROS).\n\nNeutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of Neutrophil Extracellular Traps (NETs) in other auto-immune diseases such as Systemic Lupus Erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called \"NETosis\". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE.\n\nThe investigators recently highlighted this phenomenon in SSc, especially in patients with vascular complications and\u002For at a early stage of the disease. The investigators will now explore the factors implicated in this dysregulation of NETosis in SSc.",[146,508,147,417,25],"Other Connective Tissue Disease",[510,511,512],"Systemic sclerosis","NETosis","polymorphonuclear neutrophil","2024-06-12",{"date":515,"type":39},"2024-06-17",{"date":517,"type":39},"2023-11-27",{"date":519,"type":21},"2029-04-27",{"name":521,"class":46},"CHU de Reims",{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":335,"enrollmentInfo":529,"targetDuration":4,"studyType":59,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":47},"100548373","early-phase-1-the-safety-and-efficacy-of-anti-cd19-car-t-cells-in-patients-with-relapsedrefractory-autoimmune-diseases-100548373","NCT06420154","The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed\u002FRefractory Autoimmune Diseases","An Exploratory Clinical Study to Evaluating the Safety and Efficacy of Infusiing Anti-CD19-CAR-T Cells Injection (Anti-CD19-CAR-T Cells) in Patients With Relapsed\u002FRefractory Autoimmune Diseases","Common Inclusion Criteria:\n\n1. Voluntarily participate in clinical research. The person or legal guardian fully understands and informs the research and signs the informed consent form (ICF), and is willing to follow and complete all trial procedures;\n2. Aged 18-65 years old;\n3. ECOG score ≤ 2 points;\n4. Expected survival period is at least 12 weeks;\n5. Have good intravenous access (for apheresis) and have no other contraindications to blood cell separation;\n6. When screening patients, laboratory tests must meet the following requirements and they must not have received cell growth factors within 7 days before screening hematology assessment (long-acting colony-stimulating factor (G-CSF\u002FPEG-CSF) requires an interval of 2 weeks):\n\n\u003C!-- -->\n\n1. Absolute neutrophil count ≥1.0×10\\^9\u002FL;\n2. Hemoglobin ≥60 g\u002FL (without red blood cell transfusion within 14 days);\n3. Platelets ≥50×10\\^9\u002FL;\n4. Absolute lymphocytes (ALC) ≥ 0.5×10\\^9\u002FL;\n5. Serum total bilirubin ≤1.5×upper limit of normal (ULN);\n6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;\n7. Creatinine \\\u003C1.5×ULN and endogenous creatinine clearance ≥60 mL\u002Fmin. 7. The cardiac ejection fraction is ≥45%, echocardiography (ECHO) confirms that there is no pericardial effusion (except for a small amount or physiological), and the electrocardiogram results have no clinical significance; 8. Baseline oxygen saturation \\>92% under non-oxygenation conditions; 9. Women of childbearing age must have a negative serum or urine pregnancy test report (women who have undergone surgical sterilization or women who are at least 2 years postmenopausal are not considered women of childbearing potential).\n\nCommon Exclusion Criteria:\n\n1. Have active central nervous system diseases, such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;\n2. Fungal, bacterial, viral or other infections exist or are suspected and are not controlled or require intravenous antibiotic treatment; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed;\n3. Suffering from hepatitis B (hepatitis B virus surface antigen and hepatitis B DNA \\>1000 copies\u002Fml) or hepatitis C (positive hepatitis C antibody test); syphilis infection (antibody positive); human immunodeficiency virus (HIV) infection;\n4. Past medication:\n\n\u003C!-- -->\n\n1. CD19 targeted therapy;\n2. Inject live vaccines within 4 weeks before enrollment;\n3. Immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor) used within 4 weeks before enrollment;\n4. Use immunostimulatory or immune enhancer treatment (such as tacrolimus, cyclosporine, interferon-α, interferon-β, IL-2) within the 5 half-lives before apheresis;\n5. Have used systemic cytotoxic drugs within 2 weeks before enrollment, including daily or weekly low-dose maintenance chemotherapy (cyclophosphamide, ifosfamide, bendamustine, clotrexate or Melphalan, vincristine, etc.);\n6. Long-acting growth factors within 14 days before apheresis (such as pegfilgrastim) or short-acting growth factors within 5 days before apheresis or drugs used for cell mobilization (such as granulocyte colony-stimulating factor\u002Fnon- Gestin, Plexafor);\n7. The use of pharmacological doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided within 4 days before enrollment.\n\n5\\. Have a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina or other clinically significant heart diseases within 12 months before enrollment; 6. History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kosterman syndrome, Swachmann-Diamond syndrome, etc.; 7. History of symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment. Subjects need to take prophylactic anticoagulant drugs; 8. Have suffered from other malignant tumors in the past or at the same time (except for basal cell carcinoma of the skin, carcinoma in situ of the breast\u002Fcervix and other malignant tumors that have been effectively controlled without treatment in the past five years); 9. Use of other investigational pharmaceutical products within 30 days before screening; 10.Women of childbearing age who are pregnant or breastfeeding (because chemotherapy has potentially dangerous effects on the fetus or baby); 11.Male and female subjects who are unwilling to undergo birth control within 6 months from the signing of the informed consent form to the completion of the last administration of the study drug; 12.Any medical activity that may interfere with the evaluation of the safety or efficacy of the study; 13.According to the investigator's judgment, the subject is unlikely to complete all study visits or procedures required by the protocol, including follow-up visits or comply with the requirements for participation in the study; 14.Those who have used any CAR-T cell products or other genetically modified T cell therapies in the past.\n\nSpecific inclusion\u002Fexclusion criteria:\n\nRelapsed and refractory systemic lupus erythematosus： Inclusion criteria：\n\n1. Comply with the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) SLE classification criteria;\n2. In the moderate to severe active stage of the disease, SELENA-SLEDAI score \\>6;\n3. And have at least one British Island Lupus Assessment Group Index (BILAG-2004) Category A (severe performance) or two Category B (moderate performance) organ scores, or both;\n4. Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the 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: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide,tacrolimus,cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc.\n\nExclusion criteria:\n\n1. Combined with neuropsychiatric lupus;\n2. Thrombotic thrombocytopenic purpura (TTP)\u002Fmicrothrombotic vasculopathy (TMA).\n\nRelapsed and Refractory Sjogren's Syndrome Inclusion criteria：\n\n1. Meet the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary sjogren's syndrome;\n2. Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the 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: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc.\n\nExclusion criteria:\n\n1. Combined with liver cirrhosis;\n2. Combined with aplastic anemia (AA), myelodysplastic syndrome (MDS) or other myeloproliferative diseases (MPD);\n3. Drug-induced thrombocytopenia;\n4. Thrombotic thrombocytopenic purpura (TTP)\u002Fmicrothrombotic vasculopathy (TMA).\n\nRelapsed, Refractory\u002FProgressive Diffuse Scleroderma\n\nInclusion criteria： 1.Comply with the 2013 ACR classification criteria for scleroderma and comply with diffuse manifestations; 2.Combined with interstitial pneumonia: chest HRCT shows interstitial changes with ground glass exudation and the predicted value of FVC or DLCO in pulmonary function testing is \\\u003C70%; 3.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the 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: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.; 4.Definition of progress:\n\n1. Definition of skin progression: mRSS increase \\>10%;\n2. Definition of lung disease progression: FVC decreases by 10%, or FVC decreases by 5% and DLCO decreases by 15% (OMERACT progression).\n\n   Exclusion criteria:\n   1. New York heart function class IV;\n   2. There is moderate to severe pulmonary hypertension (mean pulmonary artery pressure on echocardiography \\>40 mmHg);\n   3. FVC \\\u003C45% predicted value;\n   4. DLCO \\\u003C40% predicted value;\n   5. Significant abnormalities on HRCT are not caused by SSc;\n   6. Persistent unexplained hematuria (5 red blood cells under high power) or creatinine clearance \\\u003C40ml\u002Fmin;\n   7. Patients who have had autologous stem cell transplantation in the past;\n   8. There are signs of renal crisis;\n   9. Active antral vasodilation.\n\n   Relapsed Refractory\u002FProgressive Inflammatory Myopathy\n\n   Inclusion criteria： 1.Comply with the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including DM, PM, ASS and NM); 2.For those with muscle involvement, the MMT-8 score is lower than 142 and there are at least two abnormal findings in the following five core measurements (PhGA, PtGA or extramuscular disease activity score ≥ 2 points; HAQ total score ≥ 0.25; muscle enzymes level is 1.5 times the upper limit of the normal range); 3.Myositis antibody positive; 4.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the 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: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc.\n\n   5.Definition of progressive: Rapidly progressive interstitial pneumonia occurring in a short period of time.\n\n   Exclusion criteria:\n   1. Drug-induced myositis\n   2. Inclusion body myositis;\n   3. Tumor-related myositis (myositis occurring within 2 years after tumor diagnosis).\n\n   Relapsed and Refractory ANCA-Associated Vasculitis\n\n   Inclusion criteria：\n\n   1.Meet the 2022 ACR\u002FEULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; 2.Positive ANCA-related antibodies (MPO-ANCA or PR3-ANCA positive); 3.Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis; 4.There must be at least one major item, at least 3 minor items, or at least two renal items in the BVAS assessment: hematuria and proteinuria; 5.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the 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: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.;\n\n   Exclusion criteria:\n\n   1.Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2; 2.If the patient has alveolar hemorrhage, invasive pulmonary ventilation is required and the duration is expected to exceed the screening time; 3.Dialysis or plasma exchange is required during the screening period; 4.Have received a kidney transplant.\n\n   Relapsed\u002FRefractory\u002FCatastrophic Antiphospholipid Syndrome\n\n   Inclusion criteria：\n   1. Meet the diagnostic criteria for primary antiphospholipid syndrome revised in Sydney in 2006;\n   2. Positive medium-to-high titer phospholipid antibodies (LA, B2GP1 or acL IgG\u002FIgM, more than two positive tests within 12 weeks);\n   3. Definition of relapse and refractory: use of warfarin anticoagulation or standard treatment instead of vitamin K antagonists (i.e., maintenance of the INR required for treatment) or use of standard therapeutic doses of low molecular weight heparin (LMWH), as well as use of hormones and cyclophosphamide treatment Recurrence of thrombosis;\n   4. Catastrophic antiphospholipid syndrome requires the following four criteria:\n\n   \u003C!-- -->\n\n   1. Involving three or more organs, systems and\u002For tissues;\n   2. Symptoms appear within 1 week;\n   3. Histology confirms small blood vessel obstruction in at least one organ or tissue;\n   4. aPL positive.\n\n   Exclusion criteria:\n   1. Obstetric APS;\n   2. APS merged with other CTDs;\n   3. APS involves the nervous system.",{"count":530,"type":21},9,[184],"This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.",[534,215,146,389,25,240],"Systemic Lupus Erythematosus (SLE)",[536,443,216],"CAR T","2024-05-14",{"date":539,"type":39},"2024-05-17",{"date":541,"type":21},"2024-05-27",{"date":543,"type":21},"2027-05-27",{"name":545,"class":46},"First Affiliated Hospital of Wenzhou Medical University",{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":552,"targetDuration":4,"studyType":59,"phases":553,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":47},"100537407","refractory-anca-associated-vasculitis-and-lupus-nephritis-treated-with-bcma-targeting-car-t-cells-100537407","NCT06277427","Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells","Inclusion Criteria:\n\n1. Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);\n2. If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL\u002Fminute\u002F1.73 m2;\n3. The following test values within 3 days before the collection of mononuclear cells meet the following standards:\n\n   1. Absolute lymphocyte count: ≥ 0.5 × 10 \\^ 9\u002FL \\[The use of granulocyte colony-stimulating factor (G CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination\\];\n   2. Absolute neutrophil count: ≥ 1.0 × 10 \\^ 9\u002FL \\[The use of granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination\\];\n   3. Platelets: Subject platelet count ≥ 50 × 10 \\^ 9\u002FL (subjects are not allowed to receive blood transfusion support within 7 days before the screening period laboratory examination);\n   4. Hemoglobin: ≥ 8.0 g\u002FdL (allowing the use of recombinant human erythropoietin) \\[subjects have not received red blood cell (RBC) infusion within 7 days prior to the screening period laboratory examination\\];\n   5. Creatinine clearance rate: (CrCl) or glomerular filtration rate (GFR) (Cockcroft Gault formula) ≥ 30 mL\u002Fmin;\n   6. Total bilirubin (serum): Total bilirubin (serum) ≤ 1.5 × ULN; Blood bilirubin\\>1.5 × Gilbert subjects from ULN can be enrolled with the consent of the sponsor\n   7. AST and ALT: ≤ 3.0 × ULN;\n   8. Plasma prothrombin time (PT), international standardized ratio (INR), partial prothrombin time (APTT): PT ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN\n4. Willing to sign an informed consent form.\n5. \\- for refractory ANCA-associated vasculitis\n\n   ①According to the 2022ACR\u002FEULAR criteria, diagnosed with AAV (GPA or MPA subtype), who has not achieved remission (BVAS score of 0) for ≥ 3 months after receiving standardized treatment. Severe patients who have previously undergone standardized treatment to induce remission and are now relapsing after maintenance therapy; ②The patient is currently or has a positive ANCA during the course of the disease; ③Severe illness (severe organ involvement or life-threatening) requiring treatment (BVAS score ≥ 3.0); The definition of severe illness is vasculitis with life-threatening or organ manifestations.\n6. \\- for refractory LN\n\n   * According to the 2019 American Society of Rheumatology (ACR) criteria, diagnosed with systemic lupus erythematosus, within 6 months prior to infusion, confirmed by renal tissue biopsy according to the 2003 International Society of Nephrology (ISN)\u002FSociety of Nephropathology (RPS) criteria as active, proliferative lupus nephritis (LN), type III or IV \\[excluding III (C), IV S (C), and IV G (C)\\], or type III\u002FIV combined with type V, And have received standard treatment that is ineffective or relapses after disease remission. ②Positive anti-nuclear antibodies (ANA) and\u002For anti-dsDNA antibodies during the screening period. ③The SLE Disease Activity Index (SLEDAI-2000) score during the screening period is ≥ 8. SLEDAI-2000 clinical score ≥ 6 points, but low complement and\u002For anti ds-DNA positivity can be selected. ④The estimated survival period is at least 3 months.\n\nExclusion Criteria:\n\n-Subjects who meet any of the following criteria should be excluded from this study:\n\n1. Pregnant or lactating women;\n2. If combined with alveolar hemorrhage, invasive pulmonary ventilation is required;\n3. Refractory GPA and MPA: Combined with other autoimmune diseases involving multiple organ systems, such as EGPA, SLE, IgA vasculitis (Henoch Schönlein), rheumatoid arthritis, inflammatory myositis, anti-glomerular basement membrane disease, or cryoglobulinemia vasculitis;\n4. Difficult to treat LN: severe extrarenal clinical manifestations such as lupus encephalopathy, pulmonary hemorrhage, lupus myocarditis, lupus enteritis, and lupus crisis; Other autoimmune diseases other than combined SLE, including dermatomyositis\u002Fpolymyositis, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, etc;\n5. Individuals who are known to have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any component of PRG-1801 or drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab, albumin), or have experienced severe allergic reactions in the past;\n6. A history of malignant tumors within 5 years (① subjects with cervical carcinoma in situ who have been completely removed and have not experienced recurrence or metastasis for at least 3 years may participate in this study. ② subjects with basal cell or squamous cell carcinoma who have been completely removed and have not experienced recurrence for at least 3 years may participate in this study);\n7. Obvious evidence of cardiovascular disease as follows: a N-terminal B-type natriuretic peptide (NT proBNP)\\>8500ng\u002FL; b. The New York Heart Association (NYHA) classifies heart failure as Grade IV; c. Patients who received hospitalization for unstable angina or myocardial infarction within 6 months prior to the first administration, or patients who received percutaneous cardiac intervention and received the most recent stent placement within 6 months or coronary artery bypass grafting within 6 months;\n8. Received the following medication treatment within the prescribed time before single collection: ① Received B cell depletion therapy such as rituximab within 24 weeks; ② Received biological agents (such as TNF) within 4 weeks or 2 half-lives - Treatment with inhibitors, interleukin receptor inhibitors, belizumab, and tamoxifen; ③ Received treatment such as immunosuppressants within 2 weeks or 5 half-lives ; ④ If systemic glucocorticoids need to be used for a long time from 2 weeks before single collection to the study period, the dose of the hormone should not exceed 10mg\u002Fday; ⑤ Received plasma exchange or immunosorbent therapy within 24 weeks, and received intravenous immunoglobulin (IVIG) therapy within 4 weeks.\n9. Vaccinate with live\u002Fattenuated vaccines within 4 weeks prior to single collection or during the study period;\n10. Chronic and active hepatitis B ( the HBV DNA test is higher than 500IU\u002Fml), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, or syphilis infection;\n11. There is an active infection that requires intravenous injection of antibiotics or hospitalization treatment;\n12. Major surgery or surgical treatment caused by any reason within 4 weeks prior to enrollment;\n13. Any serious and\u002For uncontrollable comorbidities that the researcher believes may interfere with the evaluation during the research process;\n14. Participated in other intervention clinical trials within 3 months prior to enrollment or within 5 drug half-lives (whichever is longer);\n15. Other conditions determined by the researcher as unsuitable for lymphocyte clearance or cell infusion, or other unsuitable patients for study.",{"count":5,"type":21},[89],"Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis.",[341,25],[442,557,558,444],"Lupus nephritis","ANCA associated vasculitis","2024-02-17",{"date":561,"type":39},"2024-02-26",{"date":563,"type":39},"2024-02-05",{"date":565,"type":21},"2027-01-31",{"name":567,"class":46},"Lingli Dong",{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":335,"enrollmentInfo":575,"targetDuration":4,"studyType":59,"phases":577,"briefSummary":579,"conditions":580,"keywords":582,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":592,"locationsCount":47},"100513424","phase-4-efficacy-and-safety-for-telitacicept-in-the-remission-maintenance-treatment-of-anca-associated-vasculitis-ttcazarem-100513424","NCT05965284","Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)","A Prospective, Open-label, Controlled, Single Center Clinical Study of the Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis","Inclusion Criteria:\n\n1. Patients age 18 to 65 years, both genders can be included.\n2. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR\u002FEULAR classification criteria of GPA or MPA.\n3. Patients who are in complete remission after combined treatment with glucocorticoids and Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score (BVAS version 3) of 0. And the daily dosage of prednisone are no more than 10mg (or equivalent).\n4. Patients have to be ANCA-positive at diagnosis or during the course of their disease.\n\nExclusion Criteria:\n\n1. Patients with TPMT gene mutation.\n2. Patients who had been treated with either AZA but relapsed in the past.\n3. Patients who had been treated with either AZA but had to stop due to adverse events or intolerance.\n4. Patients who have planned for pregnancy in next 1.5 years.\n5. Patients with severe liver dysfunction(defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD(eGFR\\\u003C30ml\u002Fmin).\n6. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;\n7. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;\n8. Patients who had other autoimmune diseases.\n9. Patients with malignancy.\n10. Patients who are not eligible according to the judge of the principal investigators or site investigators.",{"count":576,"type":21},40,[578],"PHASE4","This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.",[92,581],"Maintenance Therapy",[92,583,584,585],"Telitacicept","Azathioprine","Relapse rate","2023-07-20",{"date":588,"type":39},"2023-07-28",{"date":590,"type":39},"2023-03-09",{"date":372,"type":21},{"name":593,"class":46},"Chinese SLE Treatment And Research Group",{"id":595,"slug":596,"hasResults":11,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":335,"enrollmentInfo":601,"targetDuration":4,"studyType":59,"phases":602,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":614,"locationsCount":47},"100513236","phase-4-efficacy-and-safety-for-rituximab-combined-with-telitacicept-in-the-treatment-of-anca-associated-vasculitis-ttcaavrem-100513236","NCT05962840","Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)","A Prospective, Randomized, Single-blinded Placebo-controlled, Single Center Clinical Study of the Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis","Inclusion Criteria:\n\n1. Patients age 18 to 65 years, both genders can be included.\n2. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR\u002FEULAR classification criteria of GPA or MPA.\n3. Patients have severe active AAV according to the 2021 ACR\u002Fvasculitis foundation definition.\n4. Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.\n\nExclusion Criteria:\n\n1. Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.\n2. Patients who had other autoimmune diseases.\n3. Patients with severe liver dysfunction (defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD (eGFR\\\u003C30ml\u002Fmin).\n4. Patients who are pregnant or have planned for pregnancy in next 2 years.\n5. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection.\n6. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection.\n7. Patients with malignancy.\n8. Patients who are not eligible according to the judge of the principal investigators.",{"count":576,"type":21},[578],"This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.",[25],[583,606,607],"relapse rate","remission maintain treatment","2023-07-19",{"date":610,"type":39},"2023-07-27",{"date":612,"type":39},"2023-06-29",{"date":372,"type":21},{"name":593,"class":46},{"id":616,"slug":617,"hasResults":11,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":622,"targetDuration":623,"studyType":22,"phases":4,"briefSummary":624,"conditions":625,"keywords":626,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":47},"100463472","multicenter-cohort-study-of-aav-in-hunan-of-china-100463472","NCT05315141","Multicenter Cohort Study of AAV in Hunan of China","Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China","Inclusion Criteria:\n\n* Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent\n\nExclusion Criteria:\n\n* Do not agree to sign informed consent",{"count":461,"type":21},"5 Years","This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death.",[25],[25,627,628],"ESRD","Outcome","2022-04-06",{"date":631,"type":39},"2022-04-07",{"date":633,"type":39},"2022-03-16",{"date":635,"type":21},"2027-03-16",{"name":637,"class":46},"Xiangya Hospital of Central South University"]