[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-lupus-erthematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-lupus-erthematosus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,41,71,98,131,159,190,215,241,265,315,337,355,382],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644879","inducible-co-stimulator-gene-with-systemic-lupus-erythematosus-100644879",false,"NCT07675837","Inducible Co-stimulator Gene With Systemic Lupus Erythematosus","Association of ICOS Gene Polymorphism With Susceptibility and Severity of Systemic Lupus Erythematosus.","ICOS\u002FSLE","Inclusion Criteria:\n\n* Patients diagnosed with SLE based on 2019 EULAR\u002FACR Male or female. willing to provide written informed consent for participation and genetic testing\n\nExclusion Criteria:\n\n* Other autoimmune diseases or chronic inflammatory disorders. Malignancy. Pregnancy or breastfeeding. Inability to provide informed consent.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},30,"ESTIMATED","OBSERVATIONAL","The aim of this study is to investigate the association between ICOS gene polymorphism and susceptibility to systemic lupus erythematosus (SLE), as well as its impact on disease severity.",[27],"Systemic Lupus Erthematosus","NOT_YET_RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":23},"2026-06",{"date":36,"type":23},"2027-07",{"name":38,"class":39},"South Valley University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":48,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100636354","phase-1-a-phase-1b2a-study-of-budoprutug-in-systemic-lupus-erythematosus-sle-100636354","NCT07564596","A Phase 1b\u002F2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)","A Phase 1b\u002F2a Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Aged 18 to 65 years at the time of consent.\n2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.\n3. Active, seropositive disease, with SLEDAI 2K \\>=6 at screening\n4. Inadequate response to at least one therapeutic intervention\n\nExclusion Criteria:\n\n1. Active neuropsychiatric SLE.\n2. Active lupus nephritis type III or IV that is expected to require induction therapy during the study or recently treated with induction therapy within 12 weeks.\n3. Prior diagnosis of, or fulfills diagnostic criteria for, other autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study\n4. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.",{"count":22,"type":23},"INTERVENTIONAL",[51,52],"PHASE1","PHASE2","Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b\u002F2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.",[27],[56,57,58,59,60,61],"Lupus","SLE","Biologics","Open-label","Monoclonal","anti-CD19","2026-04-27",{"date":64,"type":32},"2026-05-04",{"date":34,"type":23},{"date":67,"type":23},"2027-09",{"name":69,"class":70},"Climb Bio, Inc.","INDUSTRY",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":49,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":40},"100619702","phase-1-a-study-of-gr1803-in-systemic-lupus-erythematosus-100619702","NCT07348055","A Study of GR1803 in Systemic Lupus Erythematosus","A Phase Ib\u002FIIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* comfirmed diagnosis of systemic lupus erythematosus\n* SLEDAI-2K≥6分\n* written informed consent and ability to comply with protocol requirements\n* have received adequate dose of glucocorticoids, antimalarials, immunosuppressants for 3 months\n\nExclusion Criteria:\n\n* with unstable acute and chronic diseases\n* active infection\n* history of malignant tumor within 5 years","60 Years",{"count":80,"type":23},44,[51,52],"to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus",[27,84],"Auto Immune Disease",[86,87],"BCMA\u002FCD3 Bispecific Antibody","systemic lupus erythematosus","RECRUITING","2026-03-09",{"date":91,"type":32},"2026-03-10",{"date":93,"type":32},"2026-02-02",{"date":95,"type":23},"2027-12-01",{"name":97,"class":70},"Genrix (Shanghai) Biopharmaceutical Co., Ltd.",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":49,"phases":108,"briefSummary":109,"conditions":110,"keywords":118,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100562168","phase-2-covid-19-booster-and-iiv-schedule-in-immunocompromised-hosts-100562168","NCT06599658","COVID-19 Booster and IIV Schedule in Immunocompromised Hosts","The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts","CO2I2","Inclusion Criteria:\n\n\\- All participants must meet ALL the following inclusion criteria: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:\n\na) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen; b) People living with HIV (PLWH) receiving ART for ≥6 months who meet at least one of the following conditions: i) AIDS-defining illness in the last 6 months, ii) TB diagnosis in the last 6-months, iii) CD4\\<200 cells\u002FµL in the last 6 months, iv) CD4%\\<15% in the last 6 months, or v) absence of HIV viral suppression in the last 6 months; c) Inflammatory bowel disease (IBD) treated with a conventional or biologic immunosuppressive agent for ≥3 months; d) Rheumatoid arthritis or systemic lupus erythematosus (herein referred to as rheumatological disease (RD)) treated with a conventional or biologic immunosuppressive agent for ≥3 months.\n\nExclusion Criteria:\n\n* Potential participants who meet ANY of the following criteria will be excluded:\n\n  i. Received any of the following:\n  1. Annual vaccination against influenza \\< 6 months ago\n  2. COVID-19 booster \\< 3 months ago ii. History of any of the following:\n\n  \u003C!-- -->\n\n  1. life-threatening reaction any component of the IIV or COVID-19 vaccines\n  2. Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination\n  3. Contraindication to intramuscular vaccines such as bleeding disorder, severe thrombocytopenia, etc; iii. Receiving intravenous immunoglobulins; iv. Have underlying primary inborn errors of immunity; v. Receiving chemotherapy such as cyclophosphamide \\< 6-months ago; vi. Unable to provide informed consent",{"count":107,"type":23},660,[52],"The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).\n\nThe main questions it aims to answer are:\n\n1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later?\n2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals?\n\nResearchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2.\n\nPeople living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.",[111,112,113,27,114,115,116,117],"COVID 19","Influenza","Rheumatoid Arthritis (RA)","Inflammatory Bowel Disease","Solid Organ Transplant Recipients","Immunocompromised Host","People Living With HIV",[119,120,121],"Vaccine","Immunogenicity","Safety","2026-03-06",{"date":91,"type":32},{"date":125,"type":32},"2024-11-20",{"date":127,"type":23},"2027-03-31",{"name":129,"class":39},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",3,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":18,"minAge":138,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":49,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":40},"100577015","early-phase-1-anti-cd19bcma-car-nk-cells-in-patients-with-b-cell-mediated-autoimmune-disease-100577015","NCT06792799","Anti-CD19\u002FBCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease","An Exploratory Clinical Study on the Safety and Efficacy of CD19\u002FBCMA Chimeric Antigen Receptor NK Cells in the Treatment of B Cell-related Autoimmune Diseases in Children","Inclusion Criteria:\n\n1. Patients or their legal guardians must acknowledge the risks and procedures involved and subsequently provide informed consent to participate in the clinical trial.\n2. Predicted survival time ≥ 12 weeks;\n3. ECOG: 0\\~2;\n4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% ;\n5. Renal function: eGFR≥30ML\u002Fmin\u002F1.73m2； (For patients with an eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² or those receiving renal replacement therapy, inclusion or exclusion in the study is determined at the discretion of the investigators. )\n6. Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN;\n7. Lung function: No serious lung lesions, SpO2≥92%;\n8. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-NK infusion;\n\nSLE:\n\n1. Age:≥5 years old;\n2. Diagnosed with SLE according to the 2019 EULAR\u002FACR SLE classification criteria；\n3. Still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg\u002Fkg\u002Fd or other equivalent amount of other steriod ), hydroxychloroquine and at least 2 of the following treatments(cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, Beliumab, and rituximab,etc,al); or Intolerant to standard treatments; or the dosage of steroid can not be reduced to 5mg\u002Fd after 6-month of routine treatment.\n4. SLEDAI 2K score\\>6 points;\n5. No history of Central nervous system (CNS) disease within 60 days prior to screening;\n6. No history of macrophage activation syndrome (MAS) within one month prior to screening.\n\nMDR-SRNS\n\n1. Age ≥3 years old, gender unlimited;\n2. Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes （KDIGO） Guidelines and 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 hormone replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab); Or if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin inhibitor, if 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.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;\n3. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n\nIgA nephropathy\n\n1. Age: ≥ 5 years old, male or female;\n2. IgA nephropathy pathologically confirmed by renal biopsy;\n3. Angiotensin-Converting Enzyme Inhibitors (ACE) 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;\n4. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n\nExclusion Criteria:\n\n1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, obinutuzumab), or subjects with a history of severe allergic reactions\n2. Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；\n3. Subjects with grade III or IV heart failure (NYHA classification)\n4. 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；\n5. Renal replacement therapy has been or is being performed within 3 months prior to transfusion;\n6. 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;\n7. Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening;\n8. Patients had seizure, or other active central nervous system disease;\n9. Patients with malignant diseases such as tumors before screening, or with other serious life-threatening diseases;\n10. Secondary or congenital immunodeficiency.\n11. 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 KN5601, except for lupus (determined by the investigator)\n12. 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;\n13. Received live vaccine within 4 weeks before screening;\n14. Subjects who have received B cell-targeted drug therapy within 1 month before enrollment\n15. Tested positive in Blood pregnancy test；\n16. Patients who participated in other clinical study within 3 months prior to enrollment;\n17. 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\n18. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome","3 Years",{"count":140,"type":23},36,[142],"EARLY_PHASE1","this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19\u002FBCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.",[145,27,146,147],"Autoimmune Diseases","Multi-Drug Resistant Nephrotic Syndrome","IgAN - IgA Nephropathy",[149,146,27,147],"car-nk","2025-11-24",{"date":152,"type":32},"2025-12-01",{"date":154,"type":32},"2025-01-30",{"date":156,"type":23},"2029-06-30",{"name":158,"class":39},"The Children's Hospital of Zhejiang University School of Medicine",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":168,"conditions":169,"keywords":179,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100607417","mass-spectrometry-based-immune-profiling-in-autoimmune-diseases-100607417","NCT07188285","Mass Spectrometry-based Immune Profiling in Autoimmune Diseases","Mass Spectrometry-based Immune Profiling in Peripheral Blood of Autoimmune Diseases","Inclusion Criteria:\n\n1. Male or female, and aged 18-70 at the time of screening interview (inclusive).\n2. The diagnosis of each disease meets the following standards - Systemic lupus erythematosus: 1997 ACR lupus classification standard\n\n   * Behcet's disease: 2014 ICBD Behcet's disease classification standard\n   * ANCA-associated vasculitis: 1990 American College of Rheumatology Classification Standard\n   * Rheumatoid arthritis: 1987 ARA classification standard\n   * Ankylosing spondylitis: new york standard revised in 1984\n   * Sjogren's syndrome: 2016 ACR\u002FEULAR Sjogren's syndrome classification standard\n   * Inflammatory myopathy: Bohan recommended criteria in 1977\n   * Systemic sclerosis: SSc standard formulated by American Rheumatology Association in 1980.\n   * Psoriatic arthritis: CASPAR standard in 2006\n   * Gouty arthritis: 1997 ACR gout classification standard\n3. Disease activity status, each disease should meet the disease activity index;\n4. Glucocorticoid (≤1mg\u002Fkg\u002Fd prednisone or other hormones with equivalent dose) was used before joining the group, and DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) were allowed;\n5. When participating in the trial, the patient must be informed in writing and hope that the patient can abide by the requirements of the research follow-up plan and other protocols.\n\n   Exclusion Criteria:\n\n1\\. Use IVIg or cyclophosphamide within 1.2 months, use other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) within 3 months, and use rituximab within 6 months; 2.1 months after receiving high-dose glucocorticoid (\\> 1 mg\u002Fkg\u002Fd). 3. Serious complications: including heart failure (≥ NYHA III), renal insufficiency (creatinine clearance rate ≤30 ml\u002Fmin) and hepatic insufficiency (serum ALT or AST is greater than three times the normal upper limit, or total bilirubin is greater than the normal upper limit).\n\n4\\. Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve or brain diseases (including demyelinating diseases, such as multiple sclerosis).\n\n5\\. Suffering from serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or being hospitalized due to infection, or using intravenous antibiotics to treat infection 2 months before the first dose of treatment.\n\n6\\. Chest imaging showed abnormalities of malignant tumor or current active infection (including tuberculosis) within 3 months before enrollment.\n\n7\\. Infected with HIV(HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If the serum is positive, it is recommended to consult a doctor with expertise in treating HIV or hepatitis C virus infection.\n\n8\\. Any known malignant tumor or history of malignant tumor in the past 5 years. 9. Received any vaccination within 3 months before joining the group.",{"count":167,"type":23},500,"Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an early screening and diagnosis model of autoimmune diseases.",[27,170,171,172,173,113,174,175,176,177,178],"Sjogren's Syndrome","Inflammatory Myopathies","Systemic Sclerosis (SSc)","Vasculitis","Ankylosing Spondylitis","Osteoarthritis","Gouty Arthritis (GA)","Psoriatic Arthritis (PsA)","Healthy Controls",[180,181],"autoimmune diseases","mass spectrometry","2025-09-16",{"date":184,"type":32},"2025-09-23",{"date":182,"type":23},{"date":187,"type":23},"2026-09-30",{"name":189,"class":39},"Peking University People's Hospital",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":49,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":40},"100572754","phase-1-uc-msc-cell-therapy-study-for-systemic-lupus-erythematosus-sle-patients-100572754","NCT06737380","UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients","A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Subcutaneous Administration of Umbilical Cord Derived - Mesenchymal Stromal Cell Therapy in Addition to Standard of Care as A Treatment For Active Systemic Lupus Erythematosus","Inclusion Criteria\n\n1. Age 18-75 years at the time of screening\n2. Diagnosis of systemic lupus erythematosus (SLE), meeting at least 4 of the 11 criteria included in the American College of Rheumatology (ACR) Classification Criteria and\u002For 4 of the 17 criteria (with at least one of those being clinical and at least one being immunologic) included in the Systemic Lupus International Collaborating Clinics (SLICC) Criteria, at the screening visit.\n3. Must have a positive ANA (≥1:160 titer) or positive anti-dsDNA antibody test within 6 months of the screening visit\n4. An eGFR of ≥ 30 mL\u002Fmin\u002F1.73 m2 in the screening period\n5. Prior SLE background therapy with at least one non-biologic medication (e.g. immunosuppressant and\u002For antimalarial), not including corticosteroids, is required for ≥ 12 weeks before the screening visit.\n6. SLEDAI-2K ≥6 at the time of screening\n7. Participant able and willing to provide written informed consent\n8. Must be able and willing to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria\n\n1. History of any non-systemic lupus erythematosus (non-SLE) disease that required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the 12 weeks preceding the screening visit.\n2. History of dialysis within 12 months prior to the screening visit or expected need for renal replacement therapy (dialysis or renal transplant) within a six-month period after enrollment.\n3. Use of prednisone \\>0.5 mg\u002Fkg\u002Fday (or equivalent corticosteroid) in the 4 weeks prior to the screening visit.\n4. Any change or addition to a non-biologic immunosuppressant and\u002F or antimalarial regimen (not including corticosteroids) ≤ 12 weeks prior to the Screening visit.\n5. Treatment with an interventional agent within the washout time of 90 days or 5 half-lives prior to Baseline (Day 0), whichever is longer.\n6. Receipt of any commercially available biologic agent within the washout period described above prior to Baseline (Day 0).\n7. Receipt of prior MSC therapy within the washout time of 52 weeks prior to Baseline (Day 0).\n8. Previous treatment with any type of cellular therapy e.g., Tregs or CAR-T cells, with the exception of previous MSCs.\n9. Major surgery within 90 days prior to Baseline (Day 0) or major surgery planned during the study period\n10. Confirmed positive test for active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or tuberculosis (TB).\n11. Any active infection that has not been adequately treated or completely resolved prior to Baseline (Day 0).\n12. History of cancer, apart from adequately treated squamous or basal cell carcinoma of the skin, or cervical carcinoma in situ\n13. Pregnant or breast-feeding women and women with intention to become pregnant\u002Fto breast-feed during the duration of the trial.\n14. Women and men who do not agree to use a medically acceptable form of contraception for the duration of the trial.\n15. Any other comorbidity which may render the participant unfit for study participation according to the investigator's judgement.\n16. Any other medical condition, which in the opinion of the investigator, may impact the quality or interpretation of the data obtained from the study.","75 Years",{"count":199,"type":23},10,[51],"The goal of this clinical trial is to evaluate the safety and effectiveness of UC-MSCs in adults with systemic lupus erythematosus (SLE).\n\nThe main questions this study aims to answer are:\n\n1. Can UC-MSCs improve kidney function and reduce SLE disease activity?\n2. Are UC-MSCs safe and well-tolerated in this patient population?\n\nParticipants in this study will:\n\n* Receive UC-MSCs in a single dose in addition to standard of care treatment.\n* Provide blood and urine samples for laboratory assessments, including biomarkers and immune profiling (e.g., cytokines, complement proteins, and autoantibodies).\n* Attend regular clinic visits for physical exams, disease activity scoring, and imaging tests to monitor kidney health.\n* Complete assessments for safety, such as monitoring for adverse events and changes in laboratory values.\n\nThis study aims to provide new insights into treatment options for SLE and lupus nephritis, addressing an unmet medical need in this population.",[57,56,27,203,204],"Systemic Lupus Erythematosus","Systemic Lupus Erythematosus (SLE)",[87,57,56],"2025-09-04",{"date":208,"type":32},"2025-09-11",{"date":210,"type":32},"2025-01-07",{"date":212,"type":23},"2026-07",{"name":214,"class":70},"LiveKidney.Bio",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":49,"phases":225,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":40},"100603428","phase-1-safety-pharmacokinetics-immunogenicity-bcd-256-1-and-divozilimab-in-subjects-with-systemic-lupus-erythematosus-100603428","NCT07136389","Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus","An Open-label, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Immunogenicity BCD-256 and Divozilimab in Monotherapy and Combination Therapy With Single and Multiple Intravenous Administration to Subjects With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Signed informed consent to participate in the study and the subject's ability to comply with the requirements of the clinical study protocol.\n2. Age from 18 to 70 years at the time of signing the informed consent form.\n3. Body weight from 45 kg, BMI of 18 to 30 kg\u002Fm2.\n4. Diagnosed with SLE in accordance with at least 4 classification criteria of SLICC (2012), including 1 clinical sign or 1 immunological manifestation.\n5. Disease activity according to the SLEDAI score of 6-12.\n6. CLASI-A ≥ 9 at screening, at least one skin lesion with R-CLASI ≥ 6 at screening.\n7. Positive test for antinuclear antibodies at screening (titer ≥ 1:160) and\u002For increased level of double-stranded DNA antibody (≥ 2 ULN).\n8. History of the disease ≥24 weeks at the time of signing the informed consent form.\n9. Active skin disease according to the CLASI scale, despite the use of topical and systemic glucocorticoids and\u002For antimalarial drugs for at least 3 months at the time of signing the informed consent form.\n10. Women of childbearing potential have a negative pregnancy test at screening.\n11. Willingness of men and women of childbearing potential to use two highly effective contraception methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose. In this study, a woman is considered to be of childbearing potential if she is postmenarcheal, did not reach menopause (amenorrhea for ≥12 months, which cannot be explained by any other cause than menopause), and did not undergo surgical sterilization (removal of ovaries, fallopian tubes, and\u002For uterus).\n\nExclusion Criteria:\n\n1. Presence of active lupus nephritis or chronic kidney disease (urine protein to creatinine ratio \\>2.0 or estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73m2).\n2. A history of CNS associated with SLE, involvement including, but not limited to, the following symptoms: seizures, impaired consciousness, psychosis, delirium or confusion, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, multiple mononeuritis, or demyelinating syndromes.\n3. The presence of uncontrolled neuropsychiatric disorders, severe depression and\u002For suicide attempts at the time of signing the ICF or within 1 year prior to signing the informed consent form, as well as the risk of suicide and\u002For any mental illness as assessed by the investigator.\n4. A history of antiphospholipid syndrome.\n5. Use of the following groups of drugs before signing ICF:\n\n   * abatacept, belimumab, tocilizumab or tumor necrosis factor (TNF) inhibitors within 3 months or 5 half-lives prior to screening (whichever is longer);\n   * rituximab, atacicept, ocrelizumab or other biological agents targeting B cells within 9 months prior to screening;\n   * cyclosporine, tacrolimus, pimecrolimus, sirolimus, imiquimod, intravenous immunoglobulin, intravenous and oral cyclophosphamide, and plasmapheresis within 3 months prior to screening;\n   * thalidomide or lenalidomide within 2 months prior to screening;\n   * receiving oral glucocorticoids at a dose of \\> 20 mg \u002Fday in terms of prednisone or dose changes for at least 4 weeks prior to screening;\n   * other immunosuppressive or disease modifying treatments for SLE under at least one of the following conditions:\n\n     1. the drugs were started less than 3 months before screening,\n     2. the dose was changed within 1 month prior to screening,\n     3. the medications were taken in doses exceeding the specified amounts: antimalarial drugs (hydroxychloroquine up to 6.5 mg\u002Fkg\u002Fday, quinacrine up to 5 mg\u002Fkg\u002Fday, chloroquine 3 mg\u002Fkg\u002Fday), dapsone 150 mg\u002Fday, methotrexate 20 mg\u002Fweek, azathioprine 200 mg\u002Fday, 6-mercaptopurine 1.5 mg\u002Fkg\u002Fday, and mycophenolate mofetil 2 g\u002Fday or mycophenolate sodium 1440 mg\u002Fday.\n6. Laboratory test values:\n\n   * absolute neutrophil count \\\u003C1,500\u002FµL (1.5×109\u002FL);\n   * lymphocyte count \\\u003C800\u002FµL cells×109\u002FL (0.8×109\u002FL);\n   * platelets \\\u003C75,000\u002FµL (75×109\u002FL);\n   * hemoglobin ≤ 9 g\u002FdL (≤ 90 g\u002FL);\n   * serum creatinine \\>1.5×ULN, OR for subjects with a creatinine level \\>1.5×ULN, creatinine clearance\u002Fglomerular filtration rate \\\u003C30 mL\u002Fmin ;\n   * total bilirubin \\> 1.5 × ULN (for subjects with Gilbert's syndrome, total bilirubin levels should not exceed 50 µmol\u002FL);\n   * AST or ALT \\>2×ULN;\n   * alkaline phosphatase \\>2×ULN.\n7. Concomitant diseases and\u002For conditions that significantly increase the risk of AEs during the study:\n\n   * uncontrolled hypertension (subjects with arterial hypertension not controlled by 3 antihypertensive drugs (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg));\n   * stable angina pectoris, functional class III-IV according to the Canadian Cardiovascular Society, CCS;\n   * acute coronary syndrome less than 6 months before the start of therapy in the study;\n   * congestive heart failure (NYHA III-IV);\n   * clinically significant arrhythmia at the opinion of the investigator that are not amenable to the maximum possible antiarrhythmic therapy (therapy should be stable for 4 weeks before the first dose of BCD 256\u002Fdivozilimab);\n   * moderate or severe asthma, stage III-IV chronic obstructive pulmonary disease, history of angioneurotic edema, severe respiratory failure;\n   * any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.\n8. Any active skin diseases other than SLE that may interfere with the study and effect assessment (e.g., psoriasis, drug-induced lupus, vitiligo, rosacea, local skin infections).\n9. Documented presence of one or more systemic concomitant diseases requiring systemic glucocorticoid therapy (e.g., asthma, IBD, psoriasis, acute uveitis). Oral, rectal or any injectable route of administration will be considered systemic.\n\n   Exception: concomitant diseases requiring the use of glucocorticoids by other methods of administration (for example, topical, inhalation, intranasal, into the conjunctival sac, etc.) are allowed. Subjects with endocrinopathy requiring only hormone replacement therapy are also eligible.\n10. A history of herpes infection: herpes encephalitis, ocular herpes, and disseminated herpes infection.\n11. Documented diagnosis of chickenpox, cytomegalovirus infection, infectious mononucleosis, herpes zoster, genital herpes, herpetic gingivostomatitis within 3 months before signing the ICF and during the screening period.\n12. A current diagnosis or a history of a severe immunodeficiency of any origin.\n13. A history of or active or latent tuberculosis (positive Diaskintest®, QuantiFERON or T-SPOT.TB test, in the absence of signs of pulmonary tuberculosis on chest X-ray or CT). Subjects who have ongoing social contacts with active tuberculosis should also not be included in the clinical study.\n14. A documented diagnosis of any other chronic infection that, in the opinion of the investigator, can increase the risk of infectious complications .\n15. Active infectious diseases (requiring hospitalization, parenteral use of antibacterial, antimycotic or antiprotozoal drugs) within 8 weeks prior to signing the ICF and during the screening period.\n16. Systemic antibacterial, antimycotic or antiprotozoal therapy within 8 weeks prior to signing the ICF and during the screening period.\n17. Scheduled vaccination with live, live attenuated vaccines or non-live vaccines within 1 month prior to screening and throughout the study, and within 4 months after the last dose of the study drug or divozilimab.\n18. Established HIV infection, hepatitis B, active hepatitis C .\n19. COVID-19, major surgery within 4 weeks prior to signing the ICF or major surgery planned for the period of participation in the study.\n20. Simultaneous participation in other clinical studies, as well as previous participation in other clinical studies less than 3 months before signing the ICF, prior participation in the main period of this study.\n\n    Exception: subjects who dropped out of this study at screening.\n21. Comorbidities (including, but not limited to, metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, gastrointestinal disorders), including disorders ongoing at the time of screening, which, in the opinion of the investigator, may affect the course of SLE, the results of assessment of its symptoms, or create an unacceptable risk to the subject from study therapy.\n22. Lymphoproliferative diseases or solid tumors (including basal cell carcinoma in situ) with a remission duration of less than 5 years, except for cured cervical cancer in situ.\n23. Impossibility of intravenous administration of drugs.\n24. Hypersensitivity or allergy to any of the components of BCD-256 and divozilimab. A history of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or hybrid proteins.\n25. Pregnancy or breastfeeding, or planning pregnancy or fatherhood throughout the study and for 6 months after the last dose of the drug.","70 Years",{"count":224,"type":23},135,[51],"The goal of this clinical trial to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of BCD-256 alone and in combination with anti-CD20 therapy (divozilimab) as second- or later-line therapy in subjects with skin lesions due to mild to moderate systemic lupus erythematosus. The study consists of the first stage (cohorts 1-5) and the second stage (cohorts A - D).",[27],[229,230,231],"divozilimab","anti-BDCA2","anti-CD20","2025-08-14",{"date":234,"type":32},"2025-08-22",{"date":236,"type":32},"2025-03-27",{"date":238,"type":23},"2026-11-01",{"name":240,"class":70},"Biocad",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":49,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":40},"100579726","phase-1-safety-and-efficacy-of-universal-cd19-targeting-car-t-cells-in-refractory-autoimmune-diseases-100579726","NCT06828042","Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases","A Single-center Clinical Study Evaluating the Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells（QH103） in Refractory Autoimmune Diseases","Inclusion Criteria:\n\nCommon Inclusion Criteria:\n\n1. Age between 18-80 years (inclusive), male or female.\n2. Positive expression of CD19 on peripheral blood B cells by flow cytometry.\n3. Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.\n4. Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg\u002Fday prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed \\>5 mg\u002Fday prednisone (or an equivalent dose). If the subject is receiving antimalarials and\u002For conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.\n5. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.\n6. Willing to participate in the trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\n1. Systemic Lupus Erythematosus (SLE):\n\n   * Meets the 2019 EULAR\u002FACR classification criteria for SLE.\n   * ANA titer ≥1:80, or positive for anti-dsDNA and\u002For anti-Sm antibodies.\n   * Disease activity score (SLEDAI-2000) ≥8.\n2. Sjögren's Syndrome:\n\n   * Meets the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome.\n   * Disease activity score (ESSDAI) ≥5.\n   * Positive for anti-SSA\u002FRo antibodies.\n3. Systemic Sclerosis (SSc):\n\n   * Meets the 2013 EULAR\u002FACR classification criteria for systemic sclerosis.\n   * Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.\n   * At screening, mRSS \\>10; and\u002For active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) \\\u003C70% of predicted values.\n4. Idiopathic Inflammatory Myopathies (IIM):\n\n   * Meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).\n   * For patients with muscle involvement: a. MMT-8 score \\\u003C142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25. Muscle enzyme levels ≥1.5 times the upper normal limit. b. Alternatively, MMT-8 ≥142 but with active ILD (HRCT showing ground-glass opacities).\n   * Positive for myositis-specific antibodies.\n5. ANCA-Associated Vasculitis (AAV):\n\n   * Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.\n   * Positive for ANCA antibodies (current or historical).\n   * Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.\n6. Refractory Antiphospholipid Syndrome (APS):\n\n   * Meets the 2023 ACR\u002FEULAR diagnostic criteria for antiphospholipid syndrome.\n   * Positive for medium-to-high titers of antiphospholipid antibodies (LA, anti-β2-GP1, or ACL IgG\u002FIgM), with at least two positive results within 3 months.\n   * Definition of refractory APS: Disease remains active or relapses after remission, despite 6 months of conventional therapy, including: Anticoagulants (warfarin or standard treatment with vitamin K antagonists maintaining target INR) or low-molecular-weight heparin at standard doses. Glucocorticoids and\u002For immunosuppressants.\n   * Catastrophic APS (CAPS): Must meet all four criteria: a. Involvement of three or more organs, systems, and\u002For tissues. b. Symptoms occurring within one week. c. Histological evidence of small vessel occlusion in at least one organ or tissue. d. Positive for antiphospholipid antibodies (aPL).\n\nNote: Meeting either criterion 3 or 4 is sufficient. Patients with thrombocytopenia may not require anticoagulant therapy.\n\nExclusion Criteria:\n\n1. History of severe drug allergies or allergic constitution.\n2. Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n3. Central nervous system (CNS) diseases caused by autoimmune or non-autoimmune conditions, including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis.\n4. Dysfunction of major organs not meeting the following criteria (exceptions allowed if abnormalities are caused by autoimmune disease): a. Bone marrow function: White blood cell count ≥3×10⁹\u002FL. Neutrophil count ≥1×10⁹\u002FL (without GSF treatment within 2 weeks prior to testing). Hemoglobin ≥60 g\u002FL. Platelet count ≥50×10⁹\u002FL. b. Liver function: ALT ≤3×ULN (exceptions for ALT elevation caused by inflammatory myopathy). AST ≤3×ULN (exceptions for AST elevation caused by inflammatory myopathy). IBIL ≤1.5×ULN (exceptions for Gilbert's syndrome). Total bilirubin ≤3.0×ULN. c. Renal function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin (calculated using the Cockcroft\u002FGault formula, exceptions for acute CrCl decline caused by the disease itself). d. Coagulation function: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN. e. Cardiac function: Stable hemodynamics.\n5. Subjects with congenital immunoglobulin deficiencies.\n6. History of malignancy within the past five years.\n7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA levels exceeding the detection limit; positive hepatitis C virus (HCV) antibodies with detectable HCV RNA in peripheral blood; positive HIV antibodies; or positive syphilis test results.\n8. Subjects with psychiatric disorders or severe cognitive impairment.\n9. Participation in other clinical trials within 3 months prior to enrollment.\n10. Previous treatment with CAR-T therapy.\n11. History of severe adverse reactions to cyclophosphamide or fludarabine.\n12. Any other reason that the investigator determine that subjects cannot be included in this study.","80 Years",{"count":250,"type":23},9,[51,52],"Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS). They affect the quality of life, while in severe cases, they can be life-threatening. Additionally, they impose a heavy economic burden on society. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy.\n\nChimeric Antigen Receptor (CAR)-T cells targeting the B cell surface molecule CD19 have achieved significant clinical progress in acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma, with several CD19 CAR-T therapies approved for marketing worldwide. Increasingly, clinical studies are exploring the use of CD19 CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated.\n\nIn this study, the investigators used γδ T cells as carrier cells to investigate the safety and efficacy of universal CAR-γδ T cells in the treatment of autoimmune diseases.",[27,172,254,255,171,256],"Sjogren Syndrome","ANCA Associated Vasculitis (AAV)","Antiphospholipid Syndrome",{"date":258,"type":32},"2025-08-20",{"date":260,"type":32},"2025-07-01",{"date":262,"type":23},"2027-12-31",{"name":264,"class":39},"Peking University Third Hospital",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":18,"minAge":272,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":276,"conditions":277,"keywords":302,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":130},"100599630","cardiovascular-risk-in-children-with-chronic-conditions-study-100599630","NCT07086989","Cardiovascular Risk in Children With Chronic Conditions Study","CR3C","Inclusion criteria:\n\n1. Individuals aged between 6 and 25 years;\n2. Diagnosed with a chronic childhood condition\u002Fdisease associated with an increased risk of early cardiovascular disease;\n3. Provided informed consent (if over 18 years old) or had informed consent provided by their legal guardian (if under 18 years old) following appropriate information about the study.\n\nChronic childhood conditions\u002Fdiseases associated with increased risk of early cardiovascular disease are defined according to the 2019 American Heart Association recommendations (https:\u002F\u002Fdoi.org\u002F10.1161\u002FCIR.0000000000000618), as well as other conditions\u002Fdiseases for which at least two large-scale epidemiological studies have demonstrated an increased risk of cardiovascular disease.\n\nExclusion criteria:\n\n1. Severe intellectual and developmental disability;\n2. Decompensated heart failure;\n3. Severe primary immunodeficiency;\n4. Ongoing intravenous chemotherapy;\n5. Infectious diseases posing a public health risk; or\n6. History of regular alcohol or drug use.","6 Years","25 Years",{"count":275,"type":23},300,"Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes.\n\nRecent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops.\n\nIdentifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.",[278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,27,299,300,301],"Kidney Transplant","Familial Hypercholesterolaemia","Type 1 Diabetes Mellitus (T1DM)","Type 2 Diabetes Mellitus (T2DM)","Chronic Kidney Disease","Kawasaki Disease","Liver Transplant","Obesity and Overweight","Hypertension","Coarctation of Aorta","Bone Marrow Transplant","Cancer (Solid Tumors)","Leukemia","Lymphoma","Lipoprotein(a)","Aorta Stenosis","Non Alcoholic Fatty Liver Disease","Dyslipaemia","White Coat Hypertension","Pulmonary Hypertension","Juvenile Idiopahtic Arthritis","Inflammatory Bowel Disease (IBD)","HIV Infection","Transposition of Great Arteries",[303,304,305],"cardiovascular risk","vasculature","children with chronic conditions","2025-08-04",{"date":308,"type":32},"2025-08-08",{"date":310,"type":32},"2025-04-01",{"date":312,"type":23},"2029-01-31",{"name":314,"class":39},"Semmelweis University",{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":322,"targetDuration":324,"studyType":24,"phases":4,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":335,"locationsCount":4},"100580861","fibroblast-growth-factor-21-in-systemic-lupus-erythematosus-100580861","NCT06842810","Fibroblast Growth Factor 21 in Systemic Lupus Erythematosus","Evaluation of Serum Fibroblast Growth Factor 21 Levels in Patients With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n\\- 1- Patients who will be diagnosed as SLE according to the 2019 EULAR\u002FACR Classification criteria for Systemic Lupus Erythematosus.\n\n2-SLE Patients \\> 18 years old.\n\nExclusion Criteria:\n\n* 1-SLE Patients \\\u003C 18 years old. 2- Patients with other rheumatic diseases or overlap syndromes. 3- Patients with malignancy. 4- Patients with liver diseases.",{"count":323,"type":23},95,"2 Years","Systemic lupus erythematosus (SLE) is a chronic disorder characterized by profound immune and metabolic disturbances. It emerges due to a complex interplay of genetic and environmental factors. Alteration in immune cell metabolism is another feature of SLE. Mitochondria, serving as the main regulator of cell metabolism, exhibits pronounced dysfunction in SLE patients.\n\nKidneys are among the most frequently affected organs in SLE, with 30-40% of patients developing lupus nephritis (LN) over the course of their disease. LN patients exhibit varying degrees of renal injury, significantly reducing their survival rate. Usually, LN originates from abnormal immune responses, resulting in the formation and deposition of immune complexes in the kidneys, triggering the release of pro-inflammatory cytokines, cell adhesion molecules, and chemokines, thereby inducing inflammation. Extensive glomerular mitochondrial damage has been reported in kidney biopsies obtained from patients with LN. So, identifying peripheral immune markers of mitochondrial dysfunction may be beneficial in assessing SLE activity and the extent of organ involvement.\n\nAmong these markers, fibroblast growth factor 21 (FGF-21) is one of the circulating immune markers which is expressed in response to mitochondrial stress. FGF-21 is known to be primarily produced in the liver, but under stress conditions, it can also be produced by the kidneys. In addition, it correlates with the degree of renal impairment in various kidney diseases.",[27],[57,328],"Fibroblast growth factor 21","2025-02-21",{"date":331,"type":32},"2025-02-25",{"date":333,"type":23},"2025-05-01",{"date":262,"type":23},{"name":336,"class":39},"Assiut University",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":248,"enrollmentInfo":343,"targetDuration":4,"studyType":49,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":4},"100579235","phase-1-safety-and-efficacy-of-universal-car-t-cells-uwd-cd19-combined-with-immunosuppressants-in-the-treatment-of-refractory-autoimmune-diseases-100579235","NCT06821659","Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age between 18-80 years (inclusive), male or female.\n2. \\>40kg.\n3. Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.\n4. Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg\u002Fday prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed \\>5 mg\u002Fday prednisone (or an equivalent dose). If the subject is receiving antimalarials and\u002For conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.\n5. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.\n6. Willing to participate in the trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\nSystemic Lupus Erythematosus (SLE):\n\n1. Meets the 2019 EULAR\u002FACR classification criteria for SLE.\n2. ANA titer ≥1:80, or positive for anti-dsDNA and\u002For anti-Sm antibodies.\n3. Disease activity score (SLEDAI-2000) ≥8.\n\nSjögren's Syndrome:\n\n1. Meets the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome.\n2. Disease activity score (ESSDAI) ≥5.\n3. Positive for anti-SSA\u002FRo antibodies.\n\nSystemic Sclerosis (SSc):\n\n1. Meets the 2013 EULAR\u002FACR classification criteria for systemic sclerosis.\n2. Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.\n3. At screening, mRSS \\>10; and\u002For active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) \\\u003C70% of predicted values.\n\nIdiopathic Inflammatory Myopathies (IIM):\n\n1. Meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).\n2. For patients with muscle involvement: a. MMT-8 score \\\u003C142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25. Muscle enzyme levels ≥1.5 times the upper normal limit. b. Alternatively, MMT-8 ≥142 but with active ILD (HRCT showing ground-glass opacities).\n3. Positive for myositis-specific antibodies.\n\nANCA-Associated Vasculitis (AAV):\n\n1. Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.\n2. Positive for ANCA antibodies (current or historical).\n3. Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.\n\nExclusion Criteria:\n\n1. Subjects with a history of alcohol abuse or substance abuse within the past 24 weeks;\n2. Subjects with other psychiatric disorders such as schizophrenia or major depressive disorder;\n3. Subjects with a history of malignancies other than B-cell lymphoma;\n4. Subjects with overlapping diseases that affect the assessment of disease activity;\n5. Subjects with infections such as human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency virus infection, or chronic hepatitis B or C;\n6. Subjects with known active tuberculosis (TB) infection or bacterial infections;\n7. Subjects with a history of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, active arrhythmia, or other clinically significant heart diseases within 6 months prior to screening;\n8. Subjects with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n9. Subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels ≥3×ULN, or bilirubin \\>1.5×ULN, excluding abnormalities caused by theautoimmune disease;\n10. Subjects with chronic kidney failure stage 4 or above, defined as an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² or serum creatinine \\>2.5 mg\u002FdL;\n11. At the screening visit, subjects with any of the following significant hematologic abnormalities caused by bone marrow suppression, excluding abnormalities due to the autoimmune disease:\n\n    1. Hemoglobin \\\u003C70 g\u002FL;\n    2. Absolute neutrophil count \\\u003C500\u002Fmm³;\n    3. Platelet count \\\u003C50,000\u002Fmm³;\n12. Subjects with a history of severe adverse reactions to cyclophosphamide or fludarabine;\n13. Subjects with a prior history of CAR-T therapy;\n14. Subjects who received live vaccines within 30 days prior to CAR-T cell infusion;\n15. Subjects deemed unsuitable for participation in the study by the investigator.",{"count":250,"type":23},[51,52],"Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy. Clinical studies are exploring the use of CD19-targeting CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, we investigate the safety and efficacy of universal CD19-targeting CAR T cells in the treatment of autoimmune diseases.",[27,172,171,255,254],"2025-02-10",{"date":349,"type":32},"2025-02-12",{"date":351,"type":23},"2025-03-01",{"date":353,"type":23},"2028-12-31",{"name":264,"class":39},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":365,"conditions":366,"keywords":369,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":40},"100565491","rare-autoimmune-self-management-programme-development-100565491","NCT06642870","Rare AutoImmune SElf-management Programme Development","Rare Autoimmune Self-management Programme Development","RAISE","Inclusion Criteria:\n\n1. Diagnosis of a rare rheumatic condition made by hospital doctor or secondary care: including lupus, systemic vasculitis, myositis, Sjogren syndrome (participant self-report)\n2. Ability to give informed consent (with translation support if needed)\n\nExclusion Criteria:\n\n\\-",{"count":364,"type":23},360,"The rare autoimmune rheumatic diseases (RAIRDs) are life-long multi-system diseases that are life or organ threatening. RAIRDs can impair quality of life similar to chronic diseases such as heart failure. The aim of the study is to explore content and structure of a support programme for people with RAIRDs in focus groups and survey meetings.",[27,367,368,172,255,254],"Systemic Vasculitis","Inflammatory Myositis",[370,371,372],"Rare autoimmune rheumatic diseases","Self-management","Psychological support","2024-10-14",{"date":375,"type":32},"2024-10-15",{"date":377,"type":23},"2024-10",{"date":379,"type":23},"2026-04",{"name":381,"class":39},"University of the West of England",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":18,"minAge":389,"maxAge":19,"enrollmentInfo":390,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":4},"100561146","bone-mineral-density-in-patients-with-childhood-onset-systemic-lupus-erythematous-in-relation-to-disease-clinical-criteria-100561146","NCT06586359","Bone Mineral Density in Patients With Childhood-onset Systemic Lupus Erythematous, in Relation to Disease Clinical Criteria","Evaluation of Bone Mineral Density in Patients With Childhood-onset Systemic Lupus Erythematous, in Relation to Disease Clinical Criteria","Inclusion Criteria:\n\n1. Age of patients below 18 years old.\n2. Both sexes.\n3. The Patients should be diagnosed as SLE, according to 2019 European league against rheumatism (EULAR)\u002F American college of rheumatology (ACR) SLE classification criteria from \\>6 months ago.\n\nExclusion Criteria:\n\n1. Patients with autoimmune diseases other than CSLE.\n2. Patients not fulfilling the criteria for diagnosis of CSLE.\n3. Active infections.\n4. Malignancies.\n5. Patients with other diseases which decrease vitamin D levels as malabsorption, cholestatic jaundice and chronic kidney disease.","5 Years",{"count":391,"type":23},78,"* To determine the most common clinical characteristics in patients with childhood -onset systemic lupus erythematosus.\n* To detect prevalence of low bone mineral density in patients with childhood -onset systemic lupus erythematosus.",[27],"2024-09-04",{"date":396,"type":32},"2024-09-19",{"date":398,"type":23},"2024-10-01",{"date":400,"type":23},"2026-01-31",{"name":336,"class":39}]