[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-diseases":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,104,0,25,[9,41,73,85,110,140,166,197,217,244,267,304,329,359,380,407,437,464,497,517,542,561,582,620,641],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053923","deciphering-the-genetic-architecture-of-autoimmune-diseases-100053923",false,"NCT06948110","Deciphering the Genetic Architecture of Autoimmune Diseases","* INCLUSION CRITERIA:\n\nAny person who meets the criteria for inclusion in the study will be considered and must have the patient's signed informed consent for participation.\n\nAutoimmune Disease Diagnosis:\n\nCases:\n\n* Patients diagnosed with SLE, Sjogren's disease, scleroderma, rheumatoid arthritis, seronegative spondyloarthropathies, and systemic vasculitis, as defined by the American College of Rheumatology classification criteria.\n* Over 18 years old\n\nControls:\n\n* Family members of identified cases, and unrelated individuals. The controls would be from the same community as the patients and families studied, and of the same age and gender. Screening for autoimmune diseases and allergic diseases will be performed.\n* Over 18 years old\n\nEXCLUSION CRITERIA:\n\n-People diagnosed with a chronic viral disease: HIV, hepatitis C or HTLV-1.","ALL","18 Years","115 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","Background:\n\nAutoimmune diseases can be caused by genes people inherit from their parents. The gene changes that cause these diseases have been well studied in people with European and Asian ancestors. But some diseases behave differently in people who are native to North and South America. Researchers want to know more about the gene changes and other factors that may cause autoimmune diseases among these people. This project will be based in Peru.\n\nObjective:\n\nTo study how gene changes can lead to autoimmune diseases in people native to Peru.\n\nEligibility:\n\nPeople aged 18 years and older with an autoimmune disease. These may include systemic lupus erythematosus; Sjogren disease; scleroderma; rheumatoid arthritis; seronegative spondylo-arthropathies; and systemic vasculitis. Family members and healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 2 clinic visits; these will be 2 weeks apart. The clinics will be in Lima, Iquitos, and other sites in Peru.\n\nVisit 1: Participants will have a physical exam. They will answer questions about their health risks and habits. They will provide blood and urine samples.\n\nVisit 2: Participants will provide a second blood sample and a stool sample. They will talk about the results of their first clinical exam with researchers.\n\nThe cost of travel to and from the clinics will be provided. Participants will get $30 per visit and a snack.",[25],"Autoimmune Diseases",[27],"Systemic Lupus Erythematosus","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":21},"2026-07-16",{"date":36,"type":21},"2030-04-22",{"name":38,"class":39},"National Human Genome Research Institute (NHGRI)","NIH",2,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":40},"100054307","phase-2-metabolic-modulation-to-enhance-insulin-sensitivity-and-mitochondrial-function-in-type-1-diabetes-metmod-t1d-100054307","NCT07699380","METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)","MetMod-T1D","Inclusion Criteria:\n\n1. Adults ≥18 years to \\\u003C70 years of age with established T1D (duration ≥1 year)\n2. Currently on insulin therapy (multiple daily injections or insulin pump)\n3. HbA1c \\\u003C9.5%\n4. BMI 18.5-40 kg\u002Fm2\n5. On stable dose of RASB or statin, if indicated\n6. Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1. History of pancreatic disease (including pancreatitis) or pancreatic surgery\n2. History of cardiovascular disease or stroke within the past 6 months\n3. History of heart failure per New York Heart Association criteria\n4. History of severe edema or salt restriction requirement\n5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids\n6. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²\n7. Liver disease (ALT\u002FAST \\>3x upper limit of normal \\[ULN\\])\n8. Pregnancy, breastfeeding, or planning pregnancy during the study period\n9. Known hypersensitivity to study drug components\n10. Abnormal baseline ECG\n11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)\n12. Chronic use of anticoagulants\n13. Use of bile acid sequestering agents, inhibitors of bile acid transporters, bile acid derivatives, aluminum-based antacids, probenecid, pan-HDAC inhibitors, phase 2 metabolizing enzymes (e.g., uridine diphosphate glucuronosyl transferases), phase 1 metabolizing enzymes other than cytochrome P450 enzymes (CYPs), and OATP1B3\n14. Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein\n15. History of severe hypoglycemia requiring assistance within the past 3 months\n16. History of diabetic ketoacidosis (DKA) within the past 3 months\n17. Personal or family history of breast cancer or ovarian cancer\n18. Current participation in another clinical trial\n19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate","69 Years",{"count":50,"type":21},60,"INTERVENTIONAL",[53],"PHASE2","The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center\u002FDiabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.",[56,57,58,59,25,60,61,62,63],"Type 1 Diabetes (T1D)","Metabolic Diseases","Glucose Metabolism Disorders","Endocrine System Diseases","Immune System Diseases","Diabetes Melletus, Type 1","Nutritional and Metabolic Diseases","Combination Therapy","2026-07-09",{"date":31,"type":32},{"date":67,"type":21},"2026-06",{"date":69,"type":21},"2029-12",{"name":71,"class":72},"University of Washington","OTHER",{"id":74,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":76,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":84,"locationsCount":40},"100588953",{"count":20,"type":21},[25],[27],"2026-07-01",{"date":80,"type":32},"2026-07-02",{"date":82,"type":21},"2026-07-07",{"date":36,"type":21},{"name":38,"class":39},{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100437643","study-of-stim1-membrane-expression-100437643","NCT04978948","Study of STIM1 Membrane Expression","Study of STIM1 Membrane Expression During Autoimmune Diseases","STIMEX","Inclusion Criteria:\n\n* Diagnosis of one of the autoimmune diseases\n\nExclusion Criteria:\n\n* Treatment with rituximab in the previous 12 months","99 Years",{"count":95,"type":21},670,"The aim of this study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM.\n\nThis would allow to initiate, following this study, research and development programs on the use of anti-STIM1 antibodies in these identified autoimmune diseases of interest.",[25],[99],"autoimmune diseases","2026-06-24",{"date":102,"type":32},"2026-06-26",{"date":104,"type":32},"2021-05-11",{"date":106,"type":21},"2027-05",{"name":108,"class":72},"University Hospital, Brest",4,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":16,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":51,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":40},"100644814","early-phase-1-rd06-05-universal-cd19bcma-car-t-for-refractory-pediatric-autoimmune-diseases-100644814","NCT07674147","RD06-05 Universal CD19\u002FBCMA CAR-T for Refractory Pediatric Autoimmune Diseases","A Clinical Study of the Safety, Efficacy, and Pharmacokinetics of Universal CD19\u002FBCMA-Targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases in Children and Adolescents","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent from patient or legal guardian.\n2. Age \\>=5 to \\\u003C20 years, male or female.\n3. Important organ function meeting the following requirements (excluding abnormalities related to autoimmune disease activity): a) Bone marrow: ANC \\>=1.0x10\\^9\u002FL, hemoglobin \\>=60 g\u002FL, platelets \\>=30x10\\^9\u002FL; b) Liver: ALT \\\u003C=3xULN (except IIM-related elevation), AST \\\u003C=3xULN, total bilirubin \\\u003C=2xULN (\\\u003C=3xULN for Gilbert syndrome); c) Kidney: eGFR \\>=30 mL\u002Fmin\u002F1.73m\\^2 (lower eGFR or on renal replacement may be allowed if benefit \\> risk by investigator judgment); d) Cardiac: LVEF \\>=55% by echocardiogram; e) Pulmonary: No severe lung disease, SpO2 \\>=92%.\n4. Negative serum or urine pregnancy test for females of childbearing potential at screening.\n5. Females of childbearing potential must use highly effective contraception from at least 28 days before lymphodepletion through 12 months post-infusion. Males must use effective barrier contraception and not donate sperm from start of lymphodepletion through 12 months post-infusion.\n\n   Disease-Specific Inclusion Criteria for SLE\u002FLN:\n6. Diagnosis of SLE by 2019 EULAR\u002FACR or 2012 SLICC criteria.\n7. If renal involvement: kidney biopsy within 2 years showing active nephritis (class III, IV, V, or combination). Renal involvement defined as proteinuria \\>0.15g\u002F24h, or hematuria, or eGFR \\\u003C90.Inadequate response to standard therapy: high-dose glucocorticoid (\\>=1 mg\u002Fkg\u002Fd prednisone equivalent) + hydroxychloroquine + at least 2 DMARDs for 3 months, or intolerance, or unable to taper steroid to \\\u003C=5 mg\u002Fday at 6 months.\n8. Positive ANA, anti-dsDNA, or anti-Smith antibody.\n9. SLEDAI-2K \\>=8 and clinical SLEDAI-2K \\>=4 (renal proteinuria \\>0.5g\u002F24h or UPCR \\>500 mg\u002Fg or active urinary sediment may waive the clinical SLEDAI-2K requirement).\n10. Physician Global Assessment (PGA) \\>=1.0 (0-3 VAS).\n\n    Disease-Specific Inclusion Criteria for SSc:\n11. Diagnosis of SSc by 2013 ACR\u002FEULAR criteria.\n12. Diffuse cutaneous SSc.\n13. Evidence of active disease (e.g., new SSc within 2 years, new skin involvement or worsening mRSS within 6 months, tendon friction rubs, lung function decline, ILD progression).\n14. FVC \\>=50% and DLCO \\>=45% predicted.\n15. Failed or relapsed on conventional therapy (glucocorticoid \\>0.5 mg\u002Fkg\u002Fd prednisone equivalent + at least two immunomodulators for \\>6 months).\n\n    Disease-Specific Inclusion Criteria for IIM:\n16. Diagnosis of IIM (dermatomyositis, antisynthetase syndrome, IMNM) by 2017 ACR\u002FEULAR criteria (probability \\>=55%).\n17. Active disease: at least 2 of 6 core set abnormalities (MMT-8\\\u003C142, PhGA \\>=2 cm, PtGA \\>=2 cm, extra-muscular MDAAT \\>=2 cm, PedsQL \\>=60, CK \\>=1.5xULN).\n18. Positive myositis-specific autoantibody.\n19. Failed or relapsed on conventional therapy (glucocorticoid \\>1 mg\u002Fkg\u002Fd prednisone equivalent + at least 2 immunomodulators for \\>=6 months).\n\n    Disease-Specific Inclusion Criteria for IgAN:\n20. Biopsy-confirmed IgA nephropathy.\n21. On ACEi\u002FARB for \\>=3 months, and at least one of: a) proteinuria \\>=500 mg\u002F24h or UPCR \\>=0.5 mg\u002Fmg after \\>=3 months of steroid + at least one immunosuppressant\u002Fbiologic; b) eGFR decline \\>50% within 3 months; c) 22.intolerance to conventional therapy with benefit \\> risk.\n\nDisease-Specific Inclusion Criteria for MDR-NS:\n\n23.Meets 2025 KDIGO definition of steroid-resistant nephrotic syndrome. 24.At least one of: a) failed to achieve remission after 12 months of two different mechanism steroid-sparing agents (at least one calcineurin inhibitor); b) no remission after 3-6 months of one CNI with benefit \\> risk; c) intolerance to conventional therapy; d) coexisting systemic disease requiring long-term immunosuppression.\n\n25.Prior kidney biopsy showing minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS).\n\nExclusion Criteria:\n\n1. Co-existing autoimmune disease that may interfere with disease activity attribution or add safety risk (unless stable \\>=3 months and approved).\n2. Prior B-cell\u002FASC depletion therapy: a) Anti-CD20 or T-cell engager within 3 months (allowed if \\>3-6 months and CD19+ B-cells \\> LLN); b) Prior CD19 and BCMA dual-targeted therapy, or CD19 or BCMA targeted therapy within 6 months (allowed if \\>6 months and B-cells \\> LLN); c) Other B-cell\u002FASC targeted therapies require approval.\n3. Rapidly progressive glomerulonephritis (RPGN): \\>=50% crescents on biopsy, or doubling of serum creatinine within 2 months, or investigator judgment.\n4. Cardiac disease: NYHA class III\u002FIV heart failure, MI, angioplasty\u002Fstent, unstable angina, or other severe cardiac disease within 12 months.\n5. Severe CNS disease (traumatic brain injury, impaired consciousness, epilepsy, cerebrovascular ischemia\u002Fhemorrhage) that may affect compliance or assessment.\n6. Malignancy history except cured non-melanoma skin cancer or carcinoma in situ, unless disease-free for \\>=3 years.\n7. Primary immunodeficiency.\n8. Uncontrolled infection (simple UTI or upper respiratory infection allowed).\n9. Known history of HIV, hepatitis C, or syphilis infection.\n10. Active or latent hepatitis B infection.\n11. Positive EBV or CMV DNA or IgM at screening.\n12. History of recurrent tuberculosis.\n13. Prior CAR-T or other transgenic immune cell therapy.\n14. Live attenuated vaccine within 4 weeks before enrollment.\n15. Allergy to any component of the cell therapy product.\n16. Hypersensitivity to tacrolimus or prior grade \\>=3 tacrolimus-related toxicity requiring hospitalization (exceptions may be approved).\n17. Participation in another clinical trial within 30 days before screening.\n18. Pregnancy, breastfeeding, or unwillingness to use effective contraception.\n19. Any other condition judged by investigator as unsuitable for study.\n\n    Disease-Specific Exclusion Criteria for SLE:\n20. Active\u002Funstable neuropsychiatric lupus (seizures, psychosis, organic brain syndrome, CVA, encephalitis, CNS vasculitis) within 90 days requiring intervention.\n21. Prior treatments: belimumab\u002Ftelitacicept within 4 weeks; ianalumab within 8 weeks unless B-cells \\> LLN; \\>1 systemic NSAID within 14 days; inability to wash out NSAID before disease activity assessment; intra-articular\u002FIM glucocorticoid within 6 weeks; immunosuppressant doses above specified limits; initiation or dose change of hydroxychloroquine within 8 weeks; ACEi\u002FARB\u002FSGLT2 inhibitor dose change within 4 weeks.\n22. Disease flare requiring increased corticosteroids (\\>20 mg\u002Fday prednisone equivalent) or new immunosuppression during screening.\n\n    Disease-Specific Exclusion Criteria for IIM:\n23. Severe rhabdomyolysis or CK \\>=20xULN.\n24. FVC \\\u003C=60% predicted, or DLCO \\\u003C=70% predicted, or worsening lung function compared to prior 3-12 months.\n\n    Disease-Specific Exclusion Criteria for SSc:\n25. Anti-centromere antibody positive without ATA or anti-RNAP3.\n26. Clinically significant respiratory disease other than ILD (severe COPD, severe asthma, recent severe respiratory infection, smoking).\n27. FVC \\\u003C50% or DLCO \\\u003C40% predicted.\n28. On lung transplant list or expected within 12 months.\n29. History of scleroderma renal crisis within 6 months.\n30. SSc-like disorders (morphea, eosinophilic fasciitis, etc.).\n31. Antifibrotic drugs within 4 weeks (colchicine, D-penicillamine, pirfenidone, tyrosine kinase inhibitors).\n32. Prior chlorambucil, bone marrow transplant, or total lymphoid irradiation.\n\n    Disease-Specific Exclusion Criteria for IgAN:\n33. Secondary IgAN (cirrhosis, celiac disease, HIV, malignancy).\n34. Other cause of chronic kidney disease (diabetic nephropathy, other primary glomerulopathy) that may interfere.\n35. Uncontrolled blood pressure.\n36. Prior treatments: hydroxychloroquine dose change within 8 weeks; biologics (infliximab, eculizumab, canakinumab) within 4 weeks; prednisone \\>30 mg\u002Fday or unstable dose; endothelin receptor antagonist within 4 weeks before lymphodepletion.\n\n    Disease-Specific Exclusion Criteria for MDR-NS:\n37. Secondary nephrotic syndrome\u002Fproteinuria (infection-related, drug-related, systemic disease) that may interfere.\n38. On maintenance dialysis, need for immediate renal replacement, or expected dialysis\u002Ftransplant within 12 months.\n39. Prior treatments: ACEi\u002FARB dose change within 4 weeks; glucocorticoid dose adjustment within 2 weeks or need for \\>10 mg\u002Fday prednisone equivalent; 40.disease flare requiring increased steroids (\\>10 mg\u002Fday) or new immunosuppression during screening.","5 Years","20 Years",{"count":120,"type":21},30,[122],"EARLY_PHASE1","This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19\u002FBCMA dual-targeting chimeric antigen receptor T-cell (CAR-T), in pediatric and adolescent patients with refractory autoimmune diseases, including systemic lupus erythematosus\u002Flupus nephritis (SLE\u002FLN), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), multidrug-resistant nephrotic syndrome (MDR-NS), and refractory IgA nephropathy (IgAN).\n\nApproximately 30 eligible patients will be enrolled and receive a single intravenous infusion of RD06-05 at an initial dose of 6×10⁶ CAR+ T cells\u002Fkg, with a potential dose escalation to 10×10⁶ CAR+ T cells\u002Fkg following review by a Safety Review Committee (SRC).",[25,125,126,127,128,129],"SLE - Systemic Lupus Erythematosus","SSc-Systemic Sclerosis","IIM- Idiopathic Inflammatory Myopathies","IgAN - IgA Nephropathy","Multi-Drug Resistant Nephrotic Syndrome","NOT_YET_RECRUITING","2026-06-23",{"date":133,"type":32},"2026-06-29",{"date":135,"type":21},"2026-07",{"date":137,"type":21},"2030-07",{"name":139,"class":72},"The Children's Hospital of Zhejiang University School of Medicine",{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":51,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":165},"100545497","clinical-performance-of-the-new-plasma-filter-px2-in-tpe-treatments-100545497","NCT06382675","Clinical Performance of the New Plasma Filter PX2 in TPE Treatments","Clinical Performance of the New Plasma Filter PX2 in Combination With the multiFiltrate and multiFiltratePRO in TPE Treatments","plasmaFlux","Inclusion Criteria:\n\n* Informed consent signed and dated by study patient and investigator\u002Fauthorized physician\n* Minimum age of 18 years\n* Patients with an indication for a therapeutical plasma exchange\n* Patients to be treated with the plasma filter PX2 in combination with the multiFiltrate or multiFiltratePRO\n* No contraindication against systemic anticoagulation\n* Ability to understand the nature and requirements of the study\n\nExclusion Criteria:\n\n* Patients with known or suspected hypersensitivity to any of the materials of the PX2 plasma filter (Polysulfone, Polyvinylpyrrolidone, Polypropylene, Polyurethane, Silicone) and trial related products\n* Patients suffering from a heparin allergy\n* Patients with a prescription for TPE treatment with the completion of \\\u003C 0.8 PV and \\> 2.0 PV\n* Any conditions which could interfere with the patient's ability to comply with the study\n* Women of childbearing age (\\\u003C 55 years) without effective means of contraception, pregnancy (pregnancy test will be conducted at start) or lactation period\n* Participation in a different interventional clinical study during the preceding 30 days\n* Previous participation in this investigation",{"count":149,"type":21},46,[151],"NA","The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.\n\nThe investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment.",[25],[155],"Therapeutical Plasma Exchange","2026-06-22",{"date":100,"type":32},{"date":159,"type":32},"2024-07-18",{"date":161,"type":21},"2027-03",{"name":163,"class":164},"Fresenius Medical Care Deutschland GmbH","INDUSTRY",7,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":51,"phases":175,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100549582","phase-1-autoimmune-disease-treatment-with-mesenchymal-stem-cells-mscs-and-car-t-cells-100549582","NCT06435897","Autoimmune Disease Treatment With Mesenchymal Stem Cells (MSCs) and CAR-T Cells","Management of Autoimmune Conditions With Mesenchymal Stem Cells (MSCs) and CAR-T Cells","Inclusion Criteria:\n\n1. older than 18 years of age.\n2. established autoimmune conditions.\n3. the KPS score over 80 points, and survival time is more than 3 months.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess treatment response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.\n4. active HBV or HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CAR-T treatment.","75 Years",{"count":120,"type":21},[176,53],"PHASE1","The purpose of this study is to assess the feasibility, safety and efficacy of mesenchymal stem cells (MSCs) in combination with CAR-T cells in treating autoimmune disease. Another goal of the study is to learn more about the safety and function of the MSCs combined with CAR-T cells and their long term effects in autoimmune disease patients.",[25],[180,181,182,183,184,185,186,187],"CAR-T","MSC","autoimmune disease","autoantibody","B cell","plasma cell","CD19","BCMA","2026-06-18",{"date":131,"type":32},{"date":191,"type":32},"2024-05-15",{"date":193,"type":21},"2027-12-31",{"name":195,"class":72},"Shenzhen Geno-Immune Medical Institute",1,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":173,"enrollmentInfo":204,"targetDuration":4,"studyType":51,"phases":205,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":196},"100474589","phase-1-car-t-cells-targeting-autoimmune-diseases-100474589","NCT05459870","CAR-T Cells Targeting Autoimmune Diseases","CAR-T Cells Targeting B Cell Related Autoimmune Diseases","Inclusion Criteria:\n\n1. age older than 18 years.\n2. expression of B cell surface molecules.\n3. the KPS score over 80 points, and survival time is more than 3 months.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess treatment response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.\n4. active HBV or HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CAR-T treatment.",{"count":120,"type":21},[176,53],"The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.",[25],[180,182,183,186,187,209,210],"CD138","BAFF-R",{"date":131,"type":32},{"date":213,"type":32},"2026-06-01",{"date":215,"type":21},"2030-12-31",{"name":195,"class":72},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":173,"enrollmentInfo":224,"targetDuration":4,"studyType":51,"phases":226,"briefSummary":227,"conditions":228,"keywords":231,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"locationsCount":40},"100632399","phase-2-proof-of-concept-study-evaluating-the-efficacy-and-safety-of-ath-063-treatment-in-patients-with-relapsedrefractory-moderately-to-severely-active-ulcerative-colitis-uc-100632399","NCT07513181","Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed\u002FRefractory Moderately to Severely Active Ulcerative Colitis (UC)","A Phase 2b, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Clinical Study to Evaluate the Efficacy and Safety of ATH-063 Induction Therapy in Patients With Biologic Relapsed\u002FRefractory Moderately to Severely Active Ulcerative Colitis (UC)","Inclusion Criteria:\n\n* Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.\n* Male or female (assigned at birth, inclusive of all gender identities) participants 18 to 75 years of age, inclusive, at the time of informed consent.\n* Male or female participants must be postmenopausal\u002Fsurgically sterile, sexually abstinent, or using 2 forms of protocol-specified contraception, including 1 physical barrier method (condom or diaphragm) plus 1 highly effective method (ie, hormonal contraception., intrauterine device, intrauterine hormone-releasing system, bilateral occlusion, vasectomy, or complete sexual abstinence). Women of childbearing potential (WOCBP) must also be nonpregnant and not breastfeeding.\n* Has a diagnosis of UC confirmed by endoscopic and histologic evidence at least 4 months before screening. If confirmation is not available in source documentation, the screening endoscopy and histology reports for this trial may serve as evidence.\n* Has moderately to severely active UC, defined as a UCDSS of 5 to 9, with an EMA subscore of 2 to 3 (obtained during the central review of the screening video endoscopy).\n* Has active UC that extends \\>15 cm beyond the anal verge, as identified at the screening colonoscopy.\n* Has documentation of moderately to severely active UC that is refractory (inadequate response - signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing indicated in the product label; or loss of response - recurrence of signs and symptoms of active disease during maintenance dosing following prior clinical benefit \\[discontinuation despite clinical benefit does not qualify as having failed biologic therapy\\]) to 1 to 2 prior approved biologic\u002Fadvanced UC therapies (ie, biologic therapies, such as antitumor necrosis factor \\[TNF\\], anti-integrin, and anti-interleukin \\[IL\\]-12\u002F23 therapies; or advanced therapies, such as sphingosine 1-phosphate \\[S1P\\] receptor modulators and Janus kinase \\[JAK\\] inhibitors \\[eg, tofacitinib\\]; one of which must have been an anti-TNF therapy; the other, if applicable, may have had the same or a different mechanism of action) when given at doses approved for the treatment of UC.\n* Has documentation of an inadequate response, loss of response, or intolerance to conventional standard-of-care therapy with corticosteroids (ie, prednisone and budesonide), 5-ASAs (ie, mesalamine, sulfasalazine), or other immunomodulators (ie, thiopurines, methotrexate, cyclosporine, and tacrolimus).\n* Any prior therapy, including any investigational drug, not permitted as concomitant standard-of-care therapy must have been discontinued for at least 4 weeks or 5 half-lives prior to screening, whichever is longer, or the participant must have no active drug detected at the start of screening, as determined by therapeutic drug monitoring.\n* Has screening laboratory test results within the following parameters:\n\n  1. Hemoglobin ≥8 g\u002FdL\n  2. White blood cell (WBC) ≥3×103\u002FμL\n  3. Neutrophil count ≥1.5×103\u002FμL\n  4. Platelet count ≥100,000\u002FμL\n  5. Serum creatinine ≤1.5 mg\u002FdL and\u002For creatinine clearance \\>80 mL\u002Fmin\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values must be within 2× the upper limit of normal (ULN) for the laboratory conducting the test\n  7. Total bilirubin ≤1.5×ULN at screening in participants who do not have Gilbert's syndrome\n  8. Total bilirubin ≤2×ULN at screening in participants with Gilbert's syndrome\n\nExclusion Criteria:\n\n* Clinically significant abnormal medical history, or abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening, that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.\n* Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of oral medicines (as judged by the investigator).\n* Hospitalization for exacerbation of UC requiring intravenous (IV) corticosteroids (ie, UC flare) within 12 weeks prior to screening.\n* Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation.\n* Investigator judgment that the participant is likely to require a colectomy within 12 weeks of the start of trial medication administration.\n* Has UC that is limited to the rectum or right colon.\n* Presence or history of an enteric fistula consistent with Crohn's disease (CD).\n* History of ischemic colitis.\n* History of indeterminate colitis or microscopic colitis.\n* History of radiation colitis.\n* History of CD.\n* History of colonic stricture.\n* Positive stool test result for Clostridioides difficile (C. difficile), bacterial infection, or ova and parasites at screening (for bacterial infections, only exclusionary if the active infection requires antibiotic treatment).\n* History or evidence of any extensive colonic resection or subtotal or total colectomy (with or without presence of a stoma or ileoanal pouch) that would prevent adequate evaluation of trial intervention on clinical disease activity, as per the investigator's judgment.\n* Current colonic adenomas, dysplasia, or past confirmed colonic dysplasia that has not been eradicated (participants who have had UC \\>8 years should have had a colonoscopy to screen for dysplasia within 1 year prior to the screening visit, or this can be performed as part of the screening colonoscopy). A participant with prior history of adenomatous polyps will be eligible if the polyps have been completely removed (documented), and the participant is free of polyps and does not have evidence of dysplasia on histologic evaluation at screening.\n* Any current malignancy judged by the investigator not to be in full remission (except for basal cell and in situ squamous cell carcinomas of the skin that have been fully excised and resolved). Prior malignancy must have been in remission for \\>2 years prior to screening.\n* Exposure to \\>2 prior approved biologic\u002Fadvanced UC therapies (as defined in Inclusion Criterion) when given at doses approved for the treatment of UC.\n* Use of agents that deplete B or T cells (eg, rituximab) within 12 months of first trial medication administration.\n* Participants with potentially active hepatitis B virus (HBV) infection or at risk of reactivation of HBV infection; hepatitis C virus (HCV) antibody (anti-HCV) or HCV RNA (unless history of HCV that has been cleared and documented with sustained virologic response for \\>2 years); or human immunodeficiency virus antibodies (anti-HIV)1\u002F2 at screening.\n* Has severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease; or signs or symptoms thereof.\n* History of, or concurrent, unstable ischemic heart disease or severe congestive heart failure (New York Heart Association Class III or IV).\n* History of alcohol or drug abuse or dependence within 1 year before screening that, in the opinion of the investigator, would impair the ability of the participant to comply with trial protocol requirements.\n* Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial.\n* Receiving tube feeding, defined formula diets, or total parenteral alimentation.\n* History of bleeding disorders or recent use of antiplatelet or antithrombotic agents that in the investigator's judgment preclude safely performing endoscopic procedures and biopsy within the timeframe outlined in the trial protocol.\n* Use of drugs that are inhibitors of P-glycoprotein (P-gp; eg, amiodarone, clarithromycin, cyclosporine, ketoconazole, ritonavir, verapamil) or breast cancer resistance protein (BCRP; eg, Cyclosporin A, tacrolimus, gefitinib).\n* Any other condition that precludes adequate understanding, cooperation, and compliance with trial procedures or any condition that could pose a risk to the participant's safety (including any known hypersensitivity to the trial medication products), as per the investigator's judgment.",{"count":225,"type":21},120,[53],"The primary objective of this trial is to evaluate the clinical efficacy of ATH-063 in participants with biologic\u002Fadvanced therapy relapsed\u002Frefractory moderately to severely active UC.",[229,230,25],"Ulcerative Colitis","Inflammatory Bowel Diseases",[232,233,234,235],"Colitis","Ulcerative","IBD","Biologic refractory","2026-06-04",{"date":238,"type":32},"2026-06-08",{"date":67,"type":21},{"date":241,"type":21},"2028-12-14",{"name":243,"class":164},"Athos Therapeutics Inc",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":251,"sex":16,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":51,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":196},"100572693","phase-1-phase-1-clinical-trial-to-evaluate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-dwp212525-in-healthy-volunteers-100572693","NCT06736587","Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers","A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers","Inclusion Criteria:\n\n1. Healthy adult volunteers aged 19 to 55 years\n2. Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg\u002Fm2 to ≤ 30.0 kg\u002Fm2\n3. Received a sufficient explanation on this study\n4. Eligible as subjects in the study\n\nExclusion Criteria:\n\n1. History of diseases such as clinically significant disease of hepatobiliary\n2. Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview\n3. Hemato-oncologic diseases, including malignant tumor diagnosis\n4. Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test",true,"19 Years","55 Years",{"count":255,"type":21},84,[176],"The safety and tolerability of single and multiple administration of DWP212525",[25],"2026-06-03",{"date":238,"type":32},{"date":262,"type":32},"2024-12-10",{"date":264,"type":21},"2027-03-30",{"name":266,"class":164},"Daewoong Pharmaceutical Co. LTD.",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":303},"100159702","a-multicenter-access-and-distribution-protocol-for-unlicensed-cryopreserved-cord-blood-units-cbus-100159702","NCT01351545","A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)","A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications","Inclusion Criteria:\n\n* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment\n* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment\n* Pediatric and adult patients of any age\n\nExclusion Criteria:\n\n* Patients who are receiving only licensed CBUs\n* Cord blood transplant recipients at international transplant centers\n* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)\n* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated",{"count":275,"type":21},99999,"This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.",[278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,25,293],"Hematologic Malignancies","Inherited Disorders of Metabolism","Inherited Abnormalities of Platelets","Histiocytic Disorders","Acute Myelogenous Leukemia (AML or ANLL)","Acute Lymphoblastic Leukemia (ALL)","Other Acute Leukemia","Chronic Myelogenous Leukemia (CML)","Myelodysplastic (MDS) \u002F Myeloproliferative (MPN) Diseases","Other Leukemia","Hodgkin Lymphoma","Non-hodgkin Lymphoma","Multiple Myeloma\u002F Plasma Cell Disorder (PCD)","Inherited Abnormalities of Erythrocyte Differentiation or Function","Disorders of the Immune System","Severe Aplastic Anemia","2026-06-02",{"date":236,"type":32},{"date":297,"type":4},"2011-10",{"date":299,"type":21},"2041-10",{"name":301,"class":302},"Center for International Blood and Marrow Transplant Research","NETWORK",142,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":51,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":326,"locationsCount":328},"100413408","phase-2-a-study-of-the-safety-and-activity-of-sparsentan-for-the-treatment-of-patients-with-immunoglobulin-a-nephropathy-100413408","NCT04663204","A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy","A Multi-centre, Open-label, Exploratory Trial of the Safety and Activity of Sparsentan for the Treatment of Incident (Cohort A) and Recurrent (Cohort B) Patients With Immunoglobulin A Nephropathy","SPARTAN","For Cohort A (Patients with Incident IgAN)\n\nInclusion Criteria:\n\n* The patient is willing and able to provide signed informed consent.\n* The patient can understand written and spoken English.\n* The patient is male or female, aged ≥18 years.\n* The patient has been diagnosed with biopsy-proven IgAN within the last 6 months (calculated from the date of kidney biopsy, upon which the IgAN-positive diagnosis was made, to the signing of the informed consent form).\n* The patient has a urine total protein value ≥0.5 g\u002Fday at screening.\n* The patient has an eGFR value ≥30 mL\u002Fmin\u002F1.73 m2 at screening.\n* The patient has not previously been treated with ACEI and\u002For ARB therapy for IgAN OR has not received ACEI and\u002For ARB therapy within the last 12 months.\n* The patient has a systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.\n* Women of childbearing potential (WOCBP), beginning at menarche, must agree to the use of one highly reliable (ie, can achieve a failure rate of \\\u003C1% per year) method of contraception from 7 days prior to the first dose of trial medication until 90 days after the last dose of trial medication. Highly reliable contraception methods include stable oral, implanted, transdermal, or injected contraceptive hormones associated with inhibition of ovulation, or an intrauterine device (IUD) in place for at least 3 months. One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide), from Day 1 until 90 days after the last dose of trial medication.\n\nWOCBP are defined as those who are fertile, following menarche and until becoming postmenopausal unless permanently sterile; permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as amenorrhoea for more than 24 consecutive months without an alternative medical cause; women on hormone replacement therapy must have a documented plasma follicle-stimulating hormone level ≥40 mIU\u002FmL. All WOCBP must have a negative pregnancy test at Visit 1 (serum test) and Visit 2 (urine, with positive results confirmed by serum).\n\nExclusion Criteria:\n\n* The patient has IgAN secondary to another condition (eg, systemic lupus erythematosus, liver cirrhosis).\n* The patient, in the opinion of the Investigator, has a rapidly progressive glomerulonephritis (rapid decline in GFR and crescents on biopsy).\n* The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (haemoglobin A1c \\[HbA1c\\] \\>8%), or nonfasting blood glucose \\>10 mmol\u002FL (180 mg\u002FdL) at screening.\n* The patient has undergone any organ transplantation, with the exception of corneal transplants.\n* The patient requires any of the prohibited concomitant medications (see Section 14.4).\n* The patient has been taking any systemic immunosuppressive medications for \\>2 weeks within 6 months prior to screening.\n* The patient has a documented history of heart failure (New York Heart Association Class II-IV) and\u002For previous hospitalisation for heart failure or unexplained dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, ascites, and\u002For peripheral oedema.\n* The patient has clinically significant cerebrovascular disease (transient ischemic attack or stroke) and\u002For coronary artery disease (hospitalisation for myocardial infarction or unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularisation procedure) within 6 months prior to screening.\n* The patient has jaundice, hepatitis, or known hepatobiliary disease (including asymptomatic cholelithiasis), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2 times the upper limit of the normal range at screening.\n* The patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.\n* The patient has a screening haematocrit value \\\u003C27% or haemoglobin value \\\u003C90 g\u002FL (9 g\u002FdL).\n* The patient has a screening potassium value of \\>5.5 mmol\u002FL (5.5 mEq\u002FL).\n* The patient has a history of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).\n* The patient has a history of serious side effects or allergic response to any AngII or ERA, including sparsentan, or has a hypersensitivity to any of the excipients in the IMP.\n* The female patient is pregnant, plans to become pregnant during the course of the trial, or is breastfeeding.\n* The patient has participated in a trial of any investigational product within 28 days prior to screening, or plans to participate in such a trial during the course of this trial.\n* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the trial, including the ability to swallow the IMP whole.\n* The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.\n* Patients with a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity will be reviewed before consideration of the patient for enrolment.\n\nFor Cohort B (Recurrent IgAN following kidney transplantation)\n\nInclusion Criteria:\n\n* Male and female aged ≥18 years\n* Diagnosis of recurrent IgAN based on histological analysis of a transplanted kidney biopsied within the last 6 months\n* A time period of \\>12 months since kidney transplantation\n* UPCR ≥50 mg\u002Fmmol (≥0.44 g\u002Fg) and eGFR value ≥25 mL\u002Fmin\u002F1.73 m2\n* For patients on an ACEI and\u002For ARB, and\u002For SGLT2 inhibitor, the dosing regimen is stable for at least 6 weeks prior to and during the screening period\n* Tacrolimus treatment as part of standard of care immunosuppression following kidney transplantation\n* Systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.\n* Female patients not of childbearing potential, or of childbearing potential and agreeing to use the contraceptive methods listed in Section 5.1\n\nExclusion Criteria:\n\n* The patient has recurrent IgAN secondary to another condition or cause (eg, systemic lupus erythematosus, liver cirrhosis).\n* Evidence of alternative pathology on the kidney transplant biopsy as the main cause for proteinuria (e.g. diabetic nephropathy, chronic transplant glomerulopathy, mTORi treatment)\n* Patient has multiorgan transplants (with the exception of corneal transplants)\n* Immunosuppressive therapy (IST) regimen for kidney transplant or other chronic immunosuppressive therapies that is not stable for \\>6 weeks prior to Day 1. Exceptions include routine protocol tapering and for tacrolimus, changes in dose to meet target level\n* Treatment with enteric budesonide (nefecon) within 6 months prior to screening, or planned use of enteric budesonide (nefecon) at any time during the study.\n* Current treatment for surgical complications\n* \\\u003C3 months after anti-rejection treatment or active rejection\n* Active bacterial, fungal or viral infection and\u002For active treatment of infection including BKV, CMV, HIV, Hepatitis B and C \\\u003C3 months prior to and during the screening period\n* Current treatment for surgical complications\n* Uncontrolled diabetes mellitus (defined by HbA1C \\>8% (\\>64 mmol\u002Fmol)\n* History of heart failure (New York Heart Association (NYHA) Class II-IV)\n* Jaundice, hepatitis, or known hepatobiliary disease\n* Malignancy within the past 2 years with the exception of adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin, with no evidence or recurrence\n* Haematocrit \\\u003C27%, haemoglobin \\\u003C90 g\u002FL (9 g\u002FdL), or potassium \\>5.5 mmol\u002FL (5.5 mEq\u002FL)\n* History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition)\n* History of serious side effects or allergic response to any angiotensin II antagonist or endothelin receptor antagonist (ERA) or dual endothelin and angiotensin receptor antagonist (DEARA e.g. sparsentan)\n* The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.\n* The patient has participated in a study of any investigational product within 28 days prior to screening, or plans to participate in such a study during the course of this study.\n* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the IMP whole.\n* The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.",{"count":313,"type":21},24,[53],"To determine the nephroprotective potential of treatment with sparsentan in (1: Cohort A) patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy, and in (2: Cohort B) patients with recurrent IgAN following kidney transplantation.",[317,318,319,320,25,60],"Immunoglobulin A Nephropathy","Kidney Diseases","Glomerulonephritis, IGA","Glomerulonephritis","2026-05-29",{"date":259,"type":32},{"date":324,"type":32},"2020-12-10",{"date":193,"type":21},{"name":327,"class":72},"University of Leicester",6,{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":173,"enrollmentInfo":336,"targetDuration":4,"studyType":51,"phases":337,"briefSummary":338,"conditions":339,"keywords":345,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":355,"leadSponsor":357,"locationsCount":40},"100627972","phase-1-study-of-s-4321-in-participants-with-an-autoimmune-or-immune-mediated-disease-100627972","NCT07455578","Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease","Phase 1b, Open-Label, Exploratory Biomarker Basket Study of S-4321 in Participants With an Autoimmune or Immune-Mediated Disease","All Participants Major Inclusion Criteria:\n\n1. Adult males and females, 18 to 75 years of age (inclusive)\n2. Body mass index (BMI) ≥18.0 and \\\u003C40.0 kg\u002Fm2 with a minimum body weight of 45 kg\n3. Use of adequate contraception for both males and females. Female volunteers must be of nonchildbearing potential or if of childbearing potential, must have a negative pregnancy test.\n\nAll Participants Major Exclusion Criteria:\n\n1. Have received a PD-1 agonist, immune checkpoint agonist, immune checkpoint inhibitor, anti-CD19 or anti-CD20 agents, cell therapy, B cell modulating agents, alkylating agents, or any other immune cell depleting therapy.\n2. Have received azathioprine, cyclosporine, mycophenolate mofetil, or tacrolimus within 4 weeks\n3. Unable or unwilling to discontinue a prohibited medication\n4. Presence of clinically relevant immunosuppression\n5. Current infection or history of severe infection\n6. Any history of malignant disease, with some exceptions\n\nMajor inclusion\u002Fexclusion for each autoimmune or immune-mediated disease:\n\nFor RA:\n\n1. Confirmed diagnosis of moderate to severe active RA by the American College of Rheumatology (ACR) 2010\u002FEuropean League Against Rheumatism (EULAR) criteria for at least 3 months prior to the Screening 1 visit, and:\n\n   1. ≥6 swollen joint count based on 66 joint count\n   2. ≥6 tender joint count based on 68 joint count\n   3. Seropositive for RF and\u002For ACPA\n   4. Elevated hsCRP ≥1.2 times greater than the ULN\n   5. Does not have Class IV RA according to ACR revised criteria\n2. Inadequate response to, or loss of response, or intolerance to:\n\n   1. \\>1 conventional synthetic DMARD after 3 months of therapy OR\n   2. \\>1 biologic DMARD\u002Ftargeted synthetic DMARD after 3 months of therapy\n   3. Has not failed 3 or more bDMARDs and\u002For tsDMARDs\n\nFor PsA:\n\n1. Confirmed diagnosis of adult-onset PsA classified by the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 3 months prior to the Screening 1 visit, with all of the following:\n\n   1. Active PsO defined by at least 1 psoriasis lesion\n   2. Active disease defined by \\>3 swollen joints and \\>3 tender joints using the 76\u002F78 swollen and tender joint count\n2. Received standard doses of NSAIDs for \\>4 weeks or csDMARDs for \\>3 months and has been on a stable dose for \\>8 weeks, or participant has intolerance to NSAIDs or DMARDs\n3. Participants may be TNF inhibitor therapy naïve or may have received 1 prior TNF inhibitor\n4. Has not had inadequate response or intolerance to 2 or more bDMARDs or csDMARDs\n\nFor PsO:\n\n1. Confirmed diagnosis of moderate to severe plaque PsO for at least 6 months, with all of the following:\n\n   1. Psoriasis Area and Severity Index (PASI) \\>12 points\n   2. Static Physician's Global Assessment (sPGA) \\>3 points\n   3. Body surface area (BSA) of PsO involvement \\>10%\n2. Cannot have a clinically significant flare within 12 weeks\n3. Does not have history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis\n4. Has not had inadequate response to more than 2 prior bDMARDs\n\nFor CLE (with or without systemic manifestations):\n\n1. Histologically confirmed diagnosis of CLE with or without systemic manifestations for at least 6 months\n2. Has active skin manifestations as measured by CLASI-A \\>10 or CLASI-A \\>8, if there is no alopecia or mucous membrane lesions\n3. Participant must have an active CLE lesion despite an adequate trial of antimalarial treatment for at least 6 months.\n4. Cannot have active lupus nephritis or moderate-to-severe or chronic kidney disease with eGFR \\\u003C45 mL\u002Fmin\u002F1.73m2\n5. Cannot have active neuropsychiatric SLE\n\nFor AD:\n\n1. Confirmed diagnosis of AD as defined by the American Academy of Dermatology: Guidelines of Care for the Management of Atopic Dermatitis for at least 12 months\n\n   1. Eczema Area and Severity Index (EASI) \\>16\n   2. Validated Investigator Global Assessment (vIGA-AD) \\>3\n   3. BSA of AD involvement \\>10%\n   4. PP-NRS) \\>4 (average of daily scores) during the 7 days prior to dosing\n2. Inadequate response to existing topical medications within 6 months or has a history of intolerance to topical therapy as defined by at least 1 of the following:\n\n   1. Inability to achieve good disease control after use TCS for at least 4 weeks\n   2. Documented history of clinically significant AEs with the use of TCS\n   3. Failed systemic therapies intended to treat AD within 6 months\n\nAdditional inclusion\u002Fexclusion criteria will apply.",{"count":313,"type":21},[176],"This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of multiple doses of S-4321 in adults with autoimmune or immune-mediated disease including rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), cutaneous lupus erythematosus (CLE) with or without systemic manifestations, or atopic dermatitis (AD).",[25,340,341,342,343,344],"Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Psoriasis (PsO)","Cutaneous Lupus Erythematosus (CLE)","Atopic Dermatitis (AD)",[346,347,348,349,350,344,342,341,343,351],"Autoimmune","Immune-mediated","S-4321","Seismic Therapeutic","Rheumatoid Arthritis","Cutaneous Lupus","2026-05-28",{"date":213,"type":32},{"date":67,"type":21},{"date":356,"type":21},"2027-09",{"name":358,"class":164},"Seismic Therapeutic AU Pty Ltd",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":51,"phases":368,"briefSummary":369,"conditions":370,"keywords":371,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":376,"leadSponsor":378,"locationsCount":196},"100637490","early-phase-1-safety-and-efficacy-of-ksvcbd-injection-in-autoimmune-diseases-100637490","NCT07613411","Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases","A Clinical Study to Evaluate the Safety and Efficacy of KSVCBD Injection in Patients With Autoimmune Diseases","Inclusion Criteria:\n\n1. Age 18-65 years (inclusive), any gender.\n2. Subjects diagnosed with the following autoimmune disease: moderate\u002Fsevere refractory Systemic Lupus Erythematosus, elapsed\u002Frefractory Systemic Sclerosis, relapsed\u002Frefractory ANCA-Associated Vasculitis, refractory Idiopathic Inflammatory Myopathy, active Sjögren's Syndrome, chronic\u002Frefractory Immune Thrombocytopenia, refractory Antiphospholipid Syndrome, relapsed\u002Frefractory pemphigus, relapsed\u002Frefractory IgG4-Related Disease.\n3. Having adequate organ function as required by the protocol.:\n4. Voluntarily adhere to the contraception requirements as specified in the protocol.\n5. Willing to comply with all study procedures and voluntarily participate in this study and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Previous or current active malignancy, including patients with cancer-associated polymyositis\u002Fdermatomyositis. Exceptions are cured or relapse-free for at least 3 years: cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical treatment, or ductal carcinoma in situ after radical surgery.\n2. Severe pulmonary disease within the past 1 year, such as moderate\u002Fsevere pulmonary arterial hypertension (pulmonary artery systolic pressure \\>50 mmHg on echocardiography), requirement for oxygen therapy via reservoir mask or non-invasive\u002Finvasive ventilator support at screening.\n3. Use of any of the protocol specified drugs or treatments within the specified timeframes.\n4. History or current symptoms of severe central nervous system (CNS) disease within the past 6 months.\n5. Known severe allergy to the study drug or any of its components.\n6. Presence of uncontrolled fungal, bacterial, or viral infection, or other infections considered by the investigator to make the subject unsuitable for participation.\n7. History of major organ transplant or hematopoietic stem cell\u002Fbone marrow transplantation.\n8. History of other autoimmune diseases requiring systemic treatment, other than the target indication.\n9. History of non-IIM conditions such as drug induced myopathy, HIV associated myopathy, thyroid myopathy, or family history of myopathy.\n10. Pregnant or breastfeeding women.\n11. Use of any live vaccines within 6 weeks before enrollment.\n12. Participation in another interventional clinical study and receipt of an active investigational drug within 3 months prior to signing the ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period.\n13. Psychiatric disorders with depression or suicidal tendencies.\n14. Any other factors considered by the investigator to make the subject unsuitable for enrollment or to affect the subject's participation or completion of the study.","65 Years",{"count":50,"type":21},[122],"KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, early exploratory clinical study is designed to evaluate the safety and preliminary efficacy of KSVCBD injection in patients with Autoimmune Diseases.",[25],[25,372],"Immunotherapy","2026-05-22",{"date":321,"type":32},{"date":213,"type":21},{"date":377,"type":21},"2029-03-31",{"name":379,"class":72},"Chinese PLA General Hospital",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":16,"minAge":387,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":51,"phases":390,"briefSummary":391,"conditions":392,"keywords":397,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":196},"100639684","early-phase-1-cd19bcma-ucar-t-for-b-cell-related-autoimmune-disease-100639684","NCT07586267","CD19\u002FBCMA UCAR-T for B Cell-Related Autoimmune Disease","An Exploratory Clinical Study Evaluate the Safety and Efficacy of Universal Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA in the Treatment of B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n  1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n  2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n  3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n  4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n  5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n\n  1. Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n  2. Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n  3. SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both)；Patients with severe refractory SLE-ITP, characterized by a platelet count of \\\u003C30×10⁹\u002FL or \\\u003C50×10⁹\u002FL accompanied by bleeding tendency, regardless of the SLEDAI-2K score.\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Telitacicept or rituximab).\n  2. if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n  3. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n  4. Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n  1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n  2. \\>50% decline in eGFR within 3 months;\n  3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n  2. Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n  3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ;or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","3 Years",{"count":389,"type":21},15,[122],"This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[25,393,129,394,395,396],"Systemic Lupus Erthematosus (SLE)","IgA Nephropathy (IgAN)","Systemic Sclerosis (SSc)","ANCA Associated Systemic Vasculitis",[398,129,393,394,395,399],"UCART","ANCA associated systemic vasculitis","2026-05-12",{"date":402,"type":32},"2026-05-14",{"date":404,"type":21},"2026-05-08",{"date":215,"type":21},{"name":139,"class":72},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":416,"conditions":417,"keywords":421,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":436},"100596078","natural-history-of-type-1-interferonopathies-insights-from-a-european-cohort-100596078","NCT07040774","Natural History of Type 1 Interferonopathies: Insights From a European Cohort","EU-IFNp","Inclusion Criteria:\n\n* Genetically confirmed patient with type I interferonopathy\n* Patient affiliated to a social security scheme or beneficiary of such a scheme.\n\nExclusion Criteria:\n\n\\- Opposition of the patient and\u002For parental authority if the patient is a minor, to participation in the study.",{"count":415,"type":21},500,"Type I interferonopathies are rare autoinflammatory disorders caused by genetic defects and associated with significant morbidity and mortality. These diseases are refractory to conventional immunosuppressive therapies. They typically occur in childhood, although disease onset in adulthood has been observed. The clinical spectrum is wide and mainly involves the central nervous system. Joint involvement is also common, and more rarely, haematological features such as cytopenias or immunodeficiency may be observed.\n\nNearly all patients show consistent over-activation of the type I IFN pathway, as evidenced, the expression of IFN-stimulated genes, the so-called 'interferon signature'. To date, the natural history of interferonopathies remains unclear.\n\nIn this context, the establishment of a natural history of type I interferonopathy in patients is proposed to elucidate the pathophysiological mechanisms and identify biomarkers for diagnosis, prognosis, and disease activity, with the aim of better characterising the diversity of interferonopathies.\n\nThe main objective is to characterise the evolution of the pathology in paediatric and adult patients with type I interferonopathies.\n\nThe overall aim of this research is to propose therapeutic options tailored to patient phenotypes and to better define patient sub-groups in order to optimise the preparation of future clinical trials.",[418,419,420,25],"Genetic Disease","Immune Dysfunction","Neurological Diseases or Conditions",[422,423,424,425,426,427],"Immune dysfuntion","Neurological disease","Autoimmune diseases","Genetics diseases","Interferon","Aicardi-Goutieres Syndrom",{"date":429,"type":32},"2026-05-13",{"date":431,"type":32},"2025-10-01",{"date":433,"type":21},"2045-10",{"name":435,"class":72},"Imagine Institute",32,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":51,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":463},"100552184","testimonials-and-navigation-in-rheumatology-100552184","NCT06469788","Testimonials and Navigation in Rheumatology","Improving COVID-19 Vaccine Uptake Among Racial and Ethnic Minority Groups With Rheumatic Diseases","TANGO","Inclusion Criteria:\n\n* Adults (18+ years) with known AIRD\n* Black race and\u002For Latinx ethnicity\n* Individuals who have not obtained the updated COVID-19 vaccine series (self-report)\n\nExclusion Criteria:\n\n-Lack of access to phone",{"count":446,"type":21},1170,[151],"The overall goal of this study is to determine whether a novel, multi-modal, patient-directed behavioral intervention initiated in rheumatology clinics is an effective approach to improve uptake of updated COVID-19 vaccine.",[450,25],"Rheumatologic Disease",[452,453],"COVID-19 vaccination","Rheumatic Diseases","2026-05-01",{"date":456,"type":32},"2026-05-06",{"date":458,"type":32},"2024-12-18",{"date":460,"type":21},"2028-05-31",{"name":462,"class":72},"University of Alabama at Birmingham",3,{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":16,"minAge":472,"maxAge":473,"enrollmentInfo":474,"targetDuration":4,"studyType":51,"phases":476,"briefSummary":477,"conditions":478,"keywords":481,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":196},"100620825","single-cell-immune-response-to-controlled-gluten-ingestion-in-pediatric-celiac-disease-100620825","NCT07362654","Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease","Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease","CELLiomicS","Inclusion Criteria:\n\n* Age 8 to 14 years at study entry.\n* Diagnosis of celiac disease according to ESPGHAN 2020 criteria.\n* At least 18 months on a strict gluten-free diet (GFD).\n* Adequate adherence to the GFD, demonstrated by negative fecal gluten immunogenic peptides (GIP) prior to inclusion.\n* Asymptomatic from a gastrointestinal perspective in the preceding weeks.\n* Ability to swallow the gluten\u002Fplacebo preparation.\n* Written informed consent from parents\u002Flegal guardians and assent from the child.\n\nExclusion Criteria:\n\n* Obesity defined as BMI ≥ 95th percentile according to WHO criteria.\n* Diagnosed inflammatory bowel disease or diabetes mellitus.\n* Acute infectious illness at the time of inclusion.\n* Chronic hepatic, pulmonary, renal, or rheumatologic disease.\n* History of severe acute reactions to accidental gluten ingestion.\n* Use of oral corticosteroids or immunosuppressive therapy in the previous 3 months.\n* Any condition that, in the opinion of the investigators, may contraindicate participation or compromise study integrity.","8 Years","14 Years",{"count":475,"type":21},51,[151],"This study investigates how the immune system of children with celiac disease responds to controlled, small amounts of gluten. Children on a strict gluten-free diet are randomly assigned to receive either placebo, 50 mg of gluten, or 5 g of gluten once daily for three days, simulating real-life accidental exposure or dietary transgression. Blood samples are collected on Day 1 (before gluten intake) and Day 8 (five days after the last dose). Stool and urine samples are also collected for complementary analyses.\n\nUsing single-cell ribonucleic acid (RNA) sequencing, T-cell receptor sequencing, microRNA profiling, and exploratory metabolomics, the study aims to characterize changes in immune cell populations and gene expression after gluten exposure. The objective is to determine whether even very small amounts of gluten induce measurable systemic immune responses and whether these responses differ according to the dose administered. Understanding these mechanisms may support the development of new biomarkers and improve clinical management of pediatric celiac disease.",[479,480,25],"Celiac Disease","Gluten Sensitivity",[479,482,483,484,485,486,487],"Gluten Exposure","Single-Cell RNA Sequencing","Gluten-Free Diet","Immune Response","Pediatrics","Omics","2026-04-22",{"date":490,"type":32},"2026-04-27",{"date":492,"type":32},"2025-07-07",{"date":494,"type":21},"2026-11",{"name":496,"class":72},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":51,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":196},"100597490","car-t-therapy-for-refractory-autoimmune-diseases-100597490","NCT07059169","CAR-T Therapy for Refractory Autoimmune Diseases","An Exploratory Clinical Study of the Safety, Tolerability, and Initial Efficacy of Targeted Cluster of Differentiation 19 (CD19) CAR-T Therapy for Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age ≥18 years old, regardless of gender, signed with informed consent (ICF).\n2. Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).\n3. Patients who have been treated with ≥ 2 immunosuppressive agents for 3 months, or require ≥ 15mg glucocorticoids to maintain stable condition, or are intolerant to standard treatment, or have relative contraindications, and whose disease activity meets the following criteria:\n\n   1. For SLE patients, SLEDAI ≥ 8 points;\n   2. For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;\n   3. For SSc patients, the modified skin score (mRSS) score ranges from 10 to 35 (including cutoff values) and is associated with interstitial pneumonia (ILD);\n   4. For DM patients, diagnosed for at least 1 year;\n   5. For ANCA-AAV patients, Birmingham Vasculitis Activity Score(BVAS) score ≥ 15 and ANCA antibodies.\n4. Eastern Cooperative Oncology Group(ECOG) 0-1 points;\n5. The evaluation of important organ functions meets the following conditions:\n\n   1. Blood count: hemoglobin ≥ 60g\u002FL, platelet count ≥ 30 × 109\u002FL;\n   2. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormalities observed on electrocardiogram;\n   3. Renal function: estimated glomerular filtration rate(eGFR) ≥ 30 mL\u002Fmin\u002F1.73m2;\n   4. Liver function: Aspartate Aminotransferase(AST) and Alanine Transaminase(ALT) ≤ 3.0 upper limit of normal(ULN), total bilirubin ≤ 2.0 ULN;\n   5. Pulmonary function: diffusion capacity of the lung for carbon monoxide(DLCO) ≥ 40% expected value; forced vital capacity(FVC) ≥ 50% of expected value;\n   6. Having single or intravenous blood collection standards and no other contraindications for cell collection;\n6. The urine pregnancy test results of subjects of childbearing age are negative, and they agree to take effective contraceptive measures during the trial period, until one year after infusion;\n7. The patient or their guardian agrees to participate in this clinical trial and signs an informed consent form, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study.\n\nExclusion Criteria:\n\n1. Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;\n2. Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;\n3. Active or uncontrollable infections that require systemic treatment within the first week of screening;\n4. Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;\n5. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus(HBV) DNA titer in peripheral blood is greater than the normal reference value; Or hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer detection greater than the normal reference range; Or positive for human immunodeficiency virus (HIV) antibodies; Or those who test positive for syphilis; Or positive for cytomegalovirus (CMV) DNA detection;\n6. Received live vaccine within 4 weeks prior to screening;\n7. Pregnancy test positive individuals;\n8. Patients with malignant tumors and other malignant diseases before screening, in addition to fully treated cervical cancer in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;\n9. Screening patients who have participated in other clinical trials within the first three months;\n10. Other researchers believe that it is not suitable to participate in this study.",{"count":505,"type":21},20,[151],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19 CAR-T in the treatment of refractory autoimmune diseases.",[25],"2026-04-21",{"date":488,"type":32},{"date":512,"type":32},"2025-08-04",{"date":514,"type":21},"2027-03-31",{"name":516,"class":164},"LiangZou",{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":173,"enrollmentInfo":523,"targetDuration":4,"studyType":51,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":196},"100499882","treatment-strategies-for-igg4-rd-patients-with-superficial-organ-involvement-100499882","NCT05789030","Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement","Inclusion Criteria:\n\n* 1\\. Fulfillment of the 2019 American College of Rheumatology\u002FEuropean League against Rheumatology (ACR\u002FEULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment; 3. The addition of glucocorticoids was started at lower than 10 mg\u002Fd.\n\nExclusion Criteria:\n\n* 1\\. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.",{"count":50,"type":21},[151],"This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with superficial organ involvement: prednisone plus iguratimod and prednisone plus leflunomide.",[25],[528,529,530,531,532],"Immunoglobulin G4-Related Disease","treatment strategies","iguratimod","leflunomide","relapse","2026-04-01",{"date":535,"type":32},"2026-04-07",{"date":537,"type":32},"2022-07-01",{"date":539,"type":21},"2026-04-30",{"name":541,"class":72},"Peking Union Medical College Hospital",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":385,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":16,"minAge":387,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":51,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":559,"leadSponsor":560,"locationsCount":196},"100631939","early-phase-1-allogeneic-cd19bcma-car-t-for-b-cell-related-autoimmune-disease-100631939","NCT07507201","Allogeneic CD19\u002FBCMA CAR-T for B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n* 1)Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n* 2)Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n* 3)Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n* 4)Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n* 5)Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n* 1)Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n* 2)Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n* 3)SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both).\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n* a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n* b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n* c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n* d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n* a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n* b) \\>50% decline in eGFR within 3 months;\n* c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n* a) Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n* b) Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* c) Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ; or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.",{"count":389,"type":21},[122],"This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[25,393,129,394,395,396],[398,129,553,128,395,554],"Systemic Lupus Erthematosus","ANCA-Associated Vasculitis (AAV)","2026-03-30",{"date":557,"type":32},"2026-04-02",{"date":533,"type":21},{"date":69,"type":21},{"name":139,"class":72},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":51,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":463},"100573505","early-phase-1-a-study-of-mrna-encoding-cd19cd3-t-cell-engager-abo2203-in-patients-with-refractory-autoimmune-diseases-100573505","NCT06747156","A Study of mRNA Encoding CD19\u002FCD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases","A Clinical Study to Investigate Safety, Tolerability, and Preliminary Efficacy of mRNA Encoding CD19\u002FCD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent.\n2. Diagnosis of autoimmune diseases according to the corresponding disease classification criteria.\n3. Inadequate response to SoCs or relapsed after the treatment.\n4. Patients were on a stable dose of SoCs for at least 4 weeks prior to enrollment.\n5. Sufficient organ function.\n\nExclusion Criteria:\n\n1. Active infection, including tuberculosis, active or relapsed peptic ulcer, etc.\n2. Severe hypogammaglobulinemia or IgA deficiency.\n3. Active hepatitis or with a history of severe liver disease.\n4. History of rapid allergic reactions, eczema or asthma that cannot be controlled by topical corticosteroids.\n5. Severe cardiovascular diseases.\n6. History of cancer within past 5 years.\n7. Have other serious medical conditions.\n8. Received any of B cell targeted therapies and biologic therapies within the defined time window.\n9. History of severe allergies or known allergies to any active or inactive component of the study drug(s).\n10. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.",{"count":569,"type":21},66,[122],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of mRNA encoding CD19\u002FCD3 T cell engager (ABO2203) in patients with refractory autoimmune diseases who received inadequate response or relapsed from standard of care (SoC). The trial included dose escalation and dose expansion parts.",[25],"2026-03-22",{"date":575,"type":32},"2026-03-24",{"date":577,"type":32},"2024-12-23",{"date":579,"type":21},"2028-12",{"name":581,"class":72},"Ruijin Hospital",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":590,"targetDuration":592,"studyType":22,"phases":4,"briefSummary":593,"conditions":594,"keywords":609,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":196},"100513772","clonal-hematopoiesis-of-immunological-significance-100513772","NCT05969821","Clonal Hematopoiesis of Immunological Significance","Immuno-inflammatory Manifestations With or Without Clonal Hematopoiesis: Ambispective Cohort Study","CHIS","Inclusion Criteria:\n\n* Age \\>=18 years old;\n* Confirmed dysimmune manifestations: clinical or biological abnormality or systemic disease;\n* Presence or absence of myeloid or lymphoid blood disease according to World Health Organization (WHO) classification\n\nExclusion Criteria:\n\n* Persons benefiting from special protection: adults under guardianship and curatorship;\n* People hospitalized without their consent and not protected by law; persons deprived of liberty;\n* Persons not affiliated to the social security system",{"count":591,"type":21},5000,"10 Years","Ambispective, national, multicenter observational cohort study aimed at characterizing the satellite dysimmune manifestations of clonal hematopoiesis, including Vexas (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome.",[60,25,595,596,597,598,599,600,601,602,603,604,605,606,607,608],"Inflammation","Autoinflammatory Diseases","Vexas Syndrome","Hematopoiesis Clonal","Clonal Hematopoiesis of Indeterminate Potential","Hematologic Diseases","Myelodysplastic-Myeloproliferative Diseases","Leukemia Myelomonocytic Chronic","Myelodysplastic Syndromes","Myeloproliferative Disorders","Lymphoproliferative Disorders","Lymphoma","Leukemia","Monoclonal Gammopathy of Undetermined Significance",[595,596,610,25,599,601,605,608],"Vexas syndrome","2026-03-19",{"date":613,"type":32},"2026-03-23",{"date":615,"type":21},"2026-04",{"date":617,"type":21},"2045-09",{"name":619,"class":72},"Assistance Publique - Hôpitaux de Paris",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":627,"enrollmentInfo":628,"targetDuration":4,"studyType":51,"phases":629,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":637,"leadSponsor":639,"locationsCount":196},"100630690","cluster-of-differentiation-19-cd19b-cell-maturation-antigen-bcma-chimeric-antigen-receptor-t-cell-car-t-therapy-for-refractory-autoimmune-diseases-100630690","NCT07490951","Cluster of Differentiation 19 (CD19)\u002FB Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Refractory Autoimmune Diseases","A Clinical Study on the Safety, Tolerability and Preliminary Efficacy of Targeted CD19\u002FBCMA CAR-T Therapy in the Treatment of Refractory Autoimmune Diseases (ADs)","Inclusion Criteria:\n\n1. Age: 18\\~70 years old, male or female; provided written informed consent form (ICF).\n2. Diagnosis of one of the following diseases:\n\n   1. Systemic lupus erythematosus (SLE), diagnosed according to the European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 criteria, with Antinuclear Antibody (ANA) \\> 1:80 or positive anti-dsDNA antibody;\n   2. Sjögren's syndrome (SS), diagnosed according to the 2016 ACR\u002FEULAR criteria, with at least positive anti-Sjögren's-syndrome-related antigen A antibody (SSA) antibody;\n   3. Systemic sclerosis (SSc), diagnosed according to the 2013 ACR\u002FEULAR criteria, with ANA \\> 1:80 or positive anti-Scleroderma (SCL)-70 antibody;\n   4. Dermatomyositis (DM), meeting the 1975 Bohan and Peter criteria for DM or the 2020 European Neuromuscular Centre (ENMC)-DM classification criteria;\n   5. Antisynthetase syndrome (ASS), meeting the 2010 Conners classification criteria or the 2011 Solomon classification criteria;\n   6. Immune-mediated necrotizing myopathy (IMNM), meeting the 2020 ACR\u002FEULAR classification criteria;\n   7. Rheumatoid arthritis (RA), meeting the ACR\u002FEULAR classification criteria for RA;(8) Antineutrophil Cytoplasmic Antibody (ANCA)-associated vasculitis (AAV), including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), or eosinophilic granulomatosis with polyangiitis (EGPA), diagnosed according to the 2022 ACR\u002FEULAR criteria, with positive ANCA (any of c-ANCA, p-ANCA, anti-Proteinase 3 (PR3), or anti-Myeloperoxidase (MPO) positive).\n3. Patients who have received treatment with ≥ 2 immunosuppressants for 3 months,or require prednisone ≥ 15 mg daily to maintain stable disease,or are intolerant to standard therapy, or have relative contraindications to standard therapy,and meet the following disease activity criteria:\n\n   1. For SLE patients: SLEDAI score ≥ 8;\n   2. For SS patients: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 14;\n   3. For SSc patients: modified Rodnan Skin Score (mRSS) score 10-35 (inclusive), and\u002For complicated with interstitial lung disease (ILD);\n   4. For DM patients: disease duration ≥ 1 year, and meeting all of the following:a. Skin rash Visual Analogue Scale (VAS) score (based on MDAAT) ≥ 3 cm, with at least 3 abnormal Cutaneous, Skeletal Muscle, Systemic (CSM) items;b. Active inflammation demonstrated by muscle biopsy, muscle MRI, or muscle ultrasound;c. Elevation of at least one muscle enzyme \\[creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST)\\] to a minimum level of 1.3 × upper limit of normal (ULN);\n   5. For ANCA-AAV patients: Birmingham Vasculitis Activity Score (BVAS) ≥ 15, with positive ANCA.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n5. Organ function meeting the following criteria:\n\n   1. Hematology: hemoglobin ≥ 60 g\u002FL, platelet count ≥ 20 × 10⁹\u002FL;\n   2. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormality on electrocardiogram;\n   3. Renal function: estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m²;\n   4. Hepatic function: AST and ALT ≤ 3.0 × ULN, total bilirubin ≤ 2.0 × ULN;\n   5. Eligible for leukapheresis or venous blood collection, with no other contraindications to cell collection.\n6. Female subjects of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the study until 1 year after infusion.\n7. The patient or legal guardian agrees to participate in this clinical study, signs the informed consent form, and demonstrates understanding of the purpose and procedures of the study.\n\nExclusion Criteria:\n\n1. Prior treatment with CAR-T cell therapy;\n2. Suffering from severe cardiac, hepatic, pulmonary, hematological, or endocrine diseases, for whom the investigator determines that the risks of participation outweigh the benefits;\n3. Active infection requiring systemic therapy or uncontrolled infection within 1 week prior to screening;\n4. Prior hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or acute graft-versus-host disease (GVHD) of Grade 2 or higher within 2 weeks prior to screening;\n5. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal reference range;or positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal reference range;or positive for human immunodeficiency virus (HIV) antibody;or positive for syphilis;or positive for cytomegalovirus (CMV) DNA;\n6. Administration of live vaccines within 4 weeks prior to screening;\n7. Positive pregnancy test;\n8. Patients with malignant tumors or other malignant diseases prior to screening, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ after radical surgery;\n9. Patients who participated in other clinical trials within 3 months prior to screening;\n10. Any other conditions deemed by the investigator to render the subject ineligible for this study.","70 Years",{"count":505,"type":21},[151],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19\u002FBCMA CAR-T in the treatment of refractory autoimmune diseases.",[25],[633,180],"CD19\u002FBCMA","2026-03-18",{"date":575,"type":32},{"date":573,"type":21},{"date":638,"type":21},"2029-12-31",{"name":640,"class":164},"Shenzhen Genocury Biotech Co., Ltd.",{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":16,"minAge":387,"maxAge":366,"enrollmentInfo":648,"targetDuration":4,"studyType":51,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":196},"100569019","phase-1-anti-cd19-chimeric-antigen-receptor-t-cells-for-refractory-autoimmune-diseases-100569019","NCT06688799","Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases","A Single-Center, Open-Label, Non-Randomized, Single-Arm Clinical Study on the Treatment of Refractory Autoimmune Diseases With CD19-CAR T Cells","Inclusion Criteria:\n\n1\\. Systemic lupus erythematosus (SLE) 1.1. Refractory systemic lupus erythematosus (SLE) and \u002F or refractory lupus nephritis (LN)\n\n1. Male or female patients, aged 3-65 years (including 3 and 65 years);\n2. Systemic lupus erythematosus that meets the 2019 American Society of Rheumatology (ACR) \u002F European Association of Rheumatology Consortium (EULAR) classification criteria (see Annex 2);\n3. Nuclear antibody (ANA) test is clearly positive, namely ANA titer 1:80 (based on the equivalent results of Hep-2 immunofluorescence or enzyme immunoassay) and \u002F or the test at the screening visit (based on ELISA test, 30 IU \u002F mL).\n4. Refractory systemic lupus erythematosus (SLE) and \u002F or refractory lupus nephritis (LN):\n\n\u003C!-- -->\n\n1. Patients take at least 7.5 mg of prednisolone daily to maintain low disease activity or a SLEDAI 2K score (see attachment 3) of 8 or higher.\n2. Recurrence of disease activity after failure of conventional therapy or after remission. Definition of conventional treatment: using corticosteroids (1 mg \u002F kg \u002F day) and cyclophosphamide for 6 months; or any of the following immunomodulatory drugs for more than 3 months: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents such as rituximab, belimumab, and teacept.\n\n5\\) Physical strength status score (ECOG): 0-2 points; 6) The estimated survival period of 90 days; 1.2. Immune thrombocytopenia in refractory lupus (SLE-ITP)\n\n1. Age range: 18-70 years (including 18 and 70 years), gender limitation.\n2. Patients with refractory systemic lupus erythematosus (immune thrombocytopenia): meeting SLE 2019 ACR \u002F EULAR classification criteria, with at least 2 consecutive routine blood tests showing platelets lower ; no abnormal morphology of blood cells in peripheral blood smear; morphological characteristics of bone marrow cells meeting immune thrombocytopenia. Refractory systemic lupus erythematosus (immune thrombocytopenia) was defined as at least 1 course of MP shock (1g 3 days) or high-dose hormone (1mg \u002F kg d equivalent dose of glucocorticoid) combined with 1 or more immunosuppressive agents. Thrombocytopenia except for other than non-SLE causes, such as infection, myelosuppression, macropleic, hypersplenism, etc.\n3. Clinician assessment of the patients condition allowed the use of 10mg prednisone or its equivalent dose during the study and allowed the discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).\n\n   1.3. refractory lupus thrombotic microangiopathy (SLE-TMA)\n\n\u003C!-- -->\n\n1. Age range: 18-70 years (including 18 and 70 years), gender limitation.\n2. Meet SLE-TMA standard; meet one of the following criteria, associated with SLE Microvascular hemolytic anemia, associated with elevated lactate dehydrogenase and peripheral blood smear fragmentation; and thrombocytopenia, except for other reasons; Renal biopsy suggested a TMA.\n\nRefractory systemic lupus erythematosus was defined as no TMA response with at least 1 course of MP shock (1g 3 days) or high-dose hormone (1mg \u002F kg d equivalent dose glucocorticoid) combined with 1 or more immunosuppressants.\n\nThe clinician assessed the patients condition allowed a glucocorticoid dose of up to 10mg prednisone or its equivalent dose during the study and allowed discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).\n\n1.4.SLE Myelitis\n\n1. Age: 18-60 years old.\n2. Diagnosis: meet the diagnostic criteria for SLE.\n3. Myelitis: acute or subacute paraplegia, sensory plane, sphincter dysfunction, and tendon reflex or plantar reflex abnormalities; including but not limited to spinal cord lesions confirmed by MRI. And other causes of myelitis.\n4. Severity: lower limb muscle strength grade 3\n5. Refractory \u002F recurrent nature:\n\nRefractory: ineffective against high-dose hormone shock therapy and \u002F or combined with other immunosuppressants; Relapse: at least two recurrences in the past 12 months, or three times in the past 24 months, and one recurrence in the 12 months prior to screening.\n\n1.5.SLE Pulmonary arterial hypertension (SLE-PAH)\n\n1. Age range: 18-70 years (including 18 and 70 years), gender is unlimited.\n2. Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n\u003C!-- -->\n\n1. confirmed as systemic lupus erythematosus according to the 1997 ACR or EULAR \u002F ACR revision standard in 2019;\n2. meeting the diagnostic criteria for PAH confirmed by a right heart catheter (as defined by 2022 ESC \u002F ERS guidelines for the treatment of pulmonary hypertension): 1) mean pulmonary artery pressure (mPAP) 20mmHg at rest; 2) pulmonary vascular wedge pressure (PAWP) 15mmHg,and pulmonary vascular resistance (PVR)\\> 2 WUs at rest;\n3. PAH did not reach risk stratification for patients in the low-risk group. Low-risk patients need to meet: 1) WHO cardiac function grades I-II; 2) 6 min walking distance (6 MWD)\\> 440 m; 3) BNP \\\u003C50 ng\u002FL, or NT-proBNP \\\u003C300 ng\u002FL; 4) right atrial pressure (RAP) \\\u003C8mmHg and heart index (CI) 2.5 L · min 1 · m 2.\n4. Subjects had received a standard dose of treatment before the first dose of study drug, including glucocorticoids (prednisone 0-30mg \u002F day, or other equivalent) for at least 4 weeks; antimalarials, single-agent immunosuppressors (allowed to apply immunosuppressors limited to: mycophenol ester or mycophenolic acid 1.5g \u002F day, azathioprine or 6-mercaptopurine 2mg \u002F kg \u002F day, methotrexate 15mg \u002F week, leflunomide 20mg \u002F day) for at least 12 weeks and not increased or replaced within 24 weeks after medication. Less than three (including prostaglandin analogues, endothelin receptor, antagonists, PDE-5 inhibitors, guanylate cyclase agonists) and have been stable for at least 4 weeks and do not increase or change within 24 weeks after drug treatment.\n5. Clinician assessment of the patients condition allowed the use of glucocorticoids not to 10mg prednisone or its equivalent dose during the study and allowed the withdrawal of all immunosuppressive agents (excluding hydroxychloroquine).\n\n1.6.SLE-Protein loss enteropathy (SLE-PLE)\n\n1. Age range: 18-70 years (including 18 and 70 years).\n2. Refractory SLE-PLE:\n\n\u003C!-- -->\n\n1. confirmed as systemic lupus erythematosus according to the 1997 ACR or EULAR \u002F ACR revision standard in 2019;\n2. Meet the SLE-PLE standard: meet one of the following standards. Clinical symptoms and laboratory findings associated with PLE, including hypoalbuminemia (urinary protein loss, severe liver disease or malnutrition, which is not completely explained by other pathological mechanisms) Refractory systemic lupus erythematosus was defined as no PLE response after at least 1 course of MP shock (1g 3 days) or high-dose hormone (1mg \u002F kg d equivalent dose of glucocorticoids) combined with 1 or more immunosuppressants.\n\nThe clinician assessed the patients condition allowed a glucocorticoid dose of up to 10mg prednisone or its equivalent dose during the study and allowed discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).\n\n（3）Blood pregnancy tests were negative for women of reproductive age within 7 days before trial pretreatment; any fertile male and female patient must agree to effective contraception throughout the study and for at least 2 years. According to the researchers, a patient with fertility means a biological ability to have a living baby and a normal sexual life. Female patients without fertility (i. e., meet at least one following criteria): hysterectomy or bilateral oophorectomy, or medical confirmation of ovarian failure, or postmenopause (at least 12 consecutive months of menopause in the absence of pathological or physiological causes).\n\n2\\. Sjogrens Syndrome (SS) 2.1.SS-ITP\n\n1. The age at screening was 18 \\~ 65 years old (including 18 and 65 years old);\n2. Classification classification of primary Sjogrens Syndrome according to the 2002 International Classification or ACR \u002F EULAR in 2016, the diagnosis of primary Sjogrens syndrome for at least 6 months;\n3. Positive antinuclear antibody (titer 1:80) at screening, and \u002F or anti-SSA antibody, and \u002F or anti-SSB antibody;\n4. Active relapse \u002F refractory SS should meet at least one of the following scenarios:\n5. Relapse \u002F refractory immune thrombocytopenia: refractory to first-line therapy, platelet-inducing drugs in second-line therapy and \u002F or rituximab therapy \u002F hormone dependence or intolerance, platelet \\\u003C30109 \u002F L, and PGA\\> 1.\n\n2.2.SS Myelitis\n\n1. Age: 18-60 years old.\n2. Diagnosis: Meet the diagnostic criteria for Sjogrens syndrome (SS) (such as the American College of Rheumatology (ACR) criteria).\n3. The diagnosis of NMOSD requires neurological evaluation and MRI imaging confirmation, meeting the NMOSD diagnostic criteria as follows:\n\n   The NMOSD diagnostic criteria for AQP 4-IgG positivity; At least 1 core clinical feature; AQP 4-IgG using the best available assay.\n4. Severity: lower limb muscle strength grade 3\n5. Infractability and recurrence:\n\nRefractory: ineffective against high-dose hormone shock therapy and \u002F or combined with other immunosuppressants; Relapse: at least two recurrences in the past 12 months or three in the past 24 months and one in the 12 months prior to screening.\n\n2.3.SS-PAH\n\n1）Age range: 18-70 years (including 18 and 70 years), gender is unlimited. 2）Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n1. Meet the 2002 AECG classification criteria or 2016 ACR \u002F EULAR classification criteria, and diagnosed as primary Sjogrens syndrome;\n2. meeting the diagnostic criteria for PAH confirmed by a right heart catheter (as defined by the 2022 ESC \u002F ERS guidelines for the treatment of pulmonary hypertension): 1) mean pulmonary artery pressure (mPAP) 20mmHg at rest; 2) pulmonary vascular wedge pressure (PAWP) 15mmHg; and pulmonary vascular resistance (PVR)\\> 2 WUs at rest;\n3. PAH did not reach risk stratification for patients in the low-risk group. Low-risk patients need to meet: 1) WHO cardiac function grades I-II; 2) 6 min walking distance (6 MWD)\\> 440 m; 3) BNP \\\u003C50 ng\u002FL, or NT-proBNP \\\u003C300 ng\u002FL; 4) right atrial pressure (RAP) \\\u003C8mmHg and heart index (CI) 2.5 L · min 1 · m 2.\n4. Subjects had received a standard dose of treatment before the first dose of study drug, including glucocorticoids (prednisone 0-30mg \u002F day, or other equivalent) for at least 4 weeks; antimalarials, single-agent immunosuppressors (allowed to apply immunosuppressors limited to: mycophenol ester or mycophenolic acid 1.5g \u002F day, azathioprine or 6-mercaptopurine 2mg \u002F kg \u002F day, methotrexate 15mg \u002F week, leflunomide 20mg \u002F day) for at least 12 weeks and not increased or replaced within 24 weeks after medication. Less than three (including prostaglandin analogues, endothelin receptor, antagonists, PDE-5 inhibitors, guanylate cyclase agonists) and have been stable for at least 4 weeks and do not increase or change within 24 weeks after drug treatment.\n5. Clinician assessment of the patients condition allowed the use of glucocorticoids not to 10mg prednisone or its equivalent dose during the study and allowed the withdrawal of all immunosuppressive agents (excluding hydroxychloroquine).\n\n3\\. Systemic sclerosis (SSc) 3.1.SSc-ILD And skin sclerosis\n\n1. the diagnosis of SSc was confirmed according to the 2013 ACR \u002F EULAR classification criteria\n2. Course of disease for 6 years after the first presentation of non-Raynaud phenomenon\n3. Age is 18 years old, 70 years old, gender is not limited in patients with ILD (1) ILD confirmed by chest HRCT, range 20%, ground glass shadow or grid shadow (2) Lung function: FVC% 60%, and DLCO 40% (3) MMF or CTX for more than 3 months (shortness of breath aggravation, or 5% decrease in FVC% or 10% decrease in DLCO%, or chest HRCT aggravation, except for infection and other factors)\n4. Skin sclerosis:\n\n(1) Patients with dcSSc (2) mRSS 12 points, or new skin involvement areas or skin progression (mRSS 3 points) were recorded in the past 6 months (3) Previous application of hormones \u002F immunosuppressants \u002F JAK inhibitors \u002F biological agents has poor efficacy 3.2.SSc-PAH\n\n1)Age range: 18-70 years (including 18 and 70 years), gender is unlimited. 2)Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n1. Meet the 1980 ACR or ACR \u002F EULAR classification criteria in 2013 and make a diagnosis of systemic sclerosis.\n2. meeting the diagnostic criteria for PAH confirmed by a right heart catheter (as defined by the 2022 ESC \u002F ERS guidelines for the treatment of pulmonary hypertension): 1) mean pulmonary artery pressure (mPAP) 20mmHg at rest; 2) pulmonary vascular wedge pressure (PAWP) 15mmHg; 3) and pulmonary vascular resistance (PVR)\\> 2 WUs at rest;\n3. PAH did not achieve risk stratification for patients in the low-risk group. Low-risk patients need to meet: 1) WHO cardiac function grades I-II; 2) 6 min walking distance (6 MWD)\\> 440 m; 3) BNP \\\u003C50 ng\u002FL, or NT-proBNP \\\u003C300 ng\u002FL; 4) right atrial pressure (RAP) \\\u003C8mmHg and heart index (CI) 2.5 L · min 1 · m 2.\n4. Subjects had received a standard dose of stable treatment before the first dose of study drug, including glucocorticoids (prednisone 0-30mg \u002F day, or equivalent) for at least 4 weeks; antimalarials, single-agent immunosuppressive agents (limited to moxachenolate or mycophenolic acid 1.5g \u002F day, azathioprine or 6-mercaptopurine 2mg \u002F kg \u002F day, methotrexate 15mg \u002F week, leflunomide 20mg \u002F day) for at least 12 weeks and not increased or replaced within 24 weeks after treatment. Less than three (including prostaglandin analogues, endothelin receptor, antagonists, PDE-5 inhibitors, guanylate cyclase agonists) and have been stable for at least 4 weeks and do not increase or change within 24 weeks after drug treatment.\n5. Clinician assessment of the patients condition allowed the use of glucocorticoids not to 10mg prednisone or its equivalent dose during the study and allowed the withdrawal of all immunosuppressive agents (excluding hydroxychloroquine).\n\n4\\. Antiphospholipid syndrome (APS)\n\n1. Selected patients or their legal representatives shall voluntarily sign the informed consent form.\n2. Age range: 18-70 years (including 18 and 70 years), gender is unlimited.\n3. Patients with refractory APS (immune thrombocytopenia, microangiopathic APS): APS with microangiopathy and \u002F or immune thrombocytopenia (APS-ITP).\n\nPatients with refractory microangiopathic APS: according to the 2023 ACR \u002F EULAR classification criteria for APS nephropathy, myocardial lesions, alveolar hemorrhage, adrenal hemorrhage or microthrombosis, or meet the 2003 CAPS classification criteria. Refractory APS was defined as a shock to corticosteroids or high-dose hormone combined with at least one immunosuppressive agent (including CTX, tacrolimus, MMF and cyclosporin) induced remission for 3 months with continued progression or no resolution of microangiopathy.\n\nPatients with refractory APS-ITP: at least 2 consecutive routine blood tests showed platelets lower than 50109 \u002F L; microscopic morphology of blood cells in peripheral blood smear; morphological characteristics of bone marrow cells were immune thrombocytopenia. Refractory APS-ITP (immune thrombocytopenia) was defined as receiving at least 1 course of MP shock (1g 3 days) or a high dose of hormone (1mg \u002F kg d equivalent dose of glucocorticoid) combined with 1 or more immunosuppressive agents did not achieve at least partial response. Except thrombocytopenia other non-APS causes, such as infection, bone marrow suppression, macropleism and hypersplenism.\n\nThe clinician assessed the patients condition allowed a glucocorticoid dose of up to 10mg prednisone or its equivalent dose during the study and allowed discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).\n\n5\\. Idiopathic inflammatory myopathy (IIM)\n\n1. Age range: 1870 years (including 18 and 70 years), gender unlimited, weight 40 kg at screening.\n2. Classification criteria: IIM patients: must meet the \"positive\" or \"very likely\" diagnosis (Lundberg et al 2017) according to the EULAR \u002F ACR adult idiopathic inflammatory myopathy (IIM) classification criteria, or by the 2010 Connors et al.\n3. Definition of refractory IIM: at least one immunosuppressive agent (e. g., azathioprine, methotrexate, mycophenolate, cyclosporine, tacrolimus, cyclohamide, leflunomide, etc.) that has received stable doses for over 2 months, When corticosteroids were reduced to 10mg daily prednisone or its equivalent dose or above, At least one of the following deterioration occurred: (i) ILD progression, The symptoms of shortness of breath worsened after the activity, Or an increased ILD score for lung HRCT, Or pulmonary function FVC% predicted decrease greater than 5%, Or DLco% decrease of\\> 10%; And (ii) deterioration of myositis, MMT-8 decreased\\> 5 points \u002F 150 points, Or creatine kinase elevated\\> 100U \u002F L.\n4. Definition of recurrent IIM: The reappearance of active IIM after 6 months of sustained disease remission causes new organ involvement or aggravation of the original involved organ, or the need for increased glucocorticoids and immunosuppressive agents.\n5. The clinician assessing the patients condition allowed the use of glucocorticoid doses not exceeding 10mg prednisone or its equivalent dose during the study period and permitted the discontinuation of all immunosuppressants.\n\n6\\. Anti-neutrophil cytoplasic antibody-associated vasculitis (AAV: GP A\u002FMPA)\n\n1. Severe patients diagnosed with GPA or MPA according to 2022 ACR \u002F EULAR criteria, treated with cyclophosphamide or hormone with rituximab (BVAS score of 0), or relapsed with maintenance therapy with rituximab or cyclophosphamide.(Recurrence is defined as the occurrence of at least one primary item, or 3 secondary items, or an abnormality of 1 or 2 secondary items in two consecutive follow-ups);\n2. The patient is positive for ANCA (anti-MPO or PR3 antibody) at present or during the course of the disease.\n\n   Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. intracranial hypertension or cerebral consciousness disorder: Intracranial pressure is kept above 15mmHg; Organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment and other brain lesions that require intervention.\n\n2\\. Symptomatic heart failure or severe arrhythmia: Left ventricular ejection fraction (LVEF) \\\u003C45% within 12 months prior to screening; Abnormal electrocardiogram (ECG): left bundle branch, double bundle branch block or other clinically significant abnormal electrocardiogram; Congenital long QT interval (QT) syndrome or Fridericia correction formula (QTcF) 470 ms; Congestive heart failure (New York Heart Association Class III or IV); 3. Severe respiratory failure or other respiratory symptoms that are difficult to control: 4. Along with other types of malignant tumors; 5. Diffuse endovascular coagulation; 6. Sepsis or other infections that are difficult to control: uncontrolled active systemic bacterial, viral, fungal or parasitic infections (except nail fungal infections) or other clinically significant active diseases; 7. Uncontrolled diabetes: fasting blood glucose (FBG)≥8.0mmol\u002FL, 2 hours postprandial blood glucose (PBG) 15 mmol\u002FL, glycated hemoglobin (HbA 1 c) after at least 3 months of diet, exercise or related treatment; combined with diabetic ketoacidosis or other uncontrollable diabetic complications; 8. Received organ transplantation (excluding bone marrow transplantation); 9. eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2； 10. Patients who cannot continue the immunosuppressive agents for 7 days, or repeat the disease and the investigators evaluate the risk of serious adverse reactions.",{"count":649,"type":21},18,[176,53],"The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases.",[25],[654,655],"Refractory Autoimmune Diseases","CD19 CAR-T","2026-03-06",{"date":658,"type":32},"2026-03-10",{"date":660,"type":32},"2024-11-23",{"date":662,"type":21},"2026-12",{"name":664,"class":72},"Beijing GoBroad Hospital"]