[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"system-lupus-erythematosussle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:system-lupus-erythematosussle":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,70,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100639130","the-effect-of-exercise-on-cognitive-functions-in-individuals-with-systemic-lupus-erythematosus-100639130",false,"NCT07622251","The Effect of Exercise on Cognitive Functions in Individuals With Systemic Lupus Erythematosus","Sistemik Lupus Eritematozus Tanılı Bireylere Uygulanan Aerobik Egzersizlerin Kognitif Fonksiyonlar ve Hastalık Aktivitesi Üzerine Etkisi","Inclusion Criteria:\n\n* Having been diagnosed with SLE at least one year prior according to the American Rheumatology Association (ACR) diagnostic criteria\n* Being between 25-65 years of age\n* Not having received a neuropsychiatric diagnosis\n* Having medication adjusted and being on stable medication for 3 months\n* Not being involved in a regular exercise program\n* Having a Mini Mental Test score lower than 26.\n\nExclusion Criteria:\n\n* History of secondary rheumatic disease\n* Presence of active acute or chronic infection,\n* Body mass index (BMI) ≥ 30 kg\u002Fm2,\n* Acute renal failure,\n* Cardiac and pulmonary involvement,\n* Presence of musculoskeletal and joint disorders that prevent exercise testing,\n* Pregnancy","ALL","25 Years","65 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"NA","Study Objective:\n\nTo examine the effect of aerobic exercise on disease activity and cognitive functions in patients diagnosed with SLE. Study Goals:\n\n1. To conduct comprehensive pre- and post-treatment (after 12 weeks) evaluations of SLE patients included in the study, and to determine their disease activity and cognitive levels.\n2. To apply aerobic exercise to SLE patients for three months.\n3. To analyze the effects of the aerobic exercise program on disease activity and cognitive functions.",[27],"System Lupus Erythematosus(SLE)",[29,30,31,32],"cognitive function","aerobic exercise","systemic lupus erythematosus","disease activity","NOT_YET_RECRUITING","2026-05-30",{"date":36,"type":37},"2026-06-03","ACTUAL",{"date":39,"type":21},"2026-06-05",{"date":41,"type":21},"2027-08-10",{"name":43,"class":44},"Istanbul Galata University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100632381","phase-1-study-of-ykst02-alone-or-in-combination-with-yk012-in-patients-with-active-or-refractory-systemic-lupus-erythematosus-100632381","NCT07512947","Study of YKST02 Alone or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of YKST02 as Monotherapy or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria, with active disease defined as SLEDAI-2K ≥6 at screening, and considered to have inadequate response, intolerance, or ineligibility to standard therapy.\n* Have received standard therapy for SLE for at least 12 weeks prior to screening (including corticosteroids and at least one immunosuppressant and\u002For biologic agent), or are intolerant to or unsuitable for such therapies.\n* Receiving stable background therapy prior to enrollment, including stable doses of corticosteroids (within 2 weeks prior to enrollment), and\u002For antimalarial agents or one immunosuppressant (within 4 weeks prior to enrollment).\n* Positive for at least one lupus-related autoantibody at screening (e.g., anti-dsDNA, antinuclear antibody, or anti-Smith antibody).\n* Able and willing to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Known hypersensitivity to monoclonal antibodies, immunoglobulins, or any component of the study drug.\n* Prior treatment with B cell-depleting therapies, B cell-targeting biologics, or other biologic or targeted therapies within protocol-defined washout periods.\n* Receipt of intravenous immunoglobulin or plasma exchange within protocol-defined washout periods.\n* Receipt of live or attenuated vaccines within 4 weeks prior to enrollment.\n* Presence of other active autoimmune diseases or inflammatory conditions (except secondary Sjögren's syndrome) that may interfere with assessment of SLE disease activity.\n* History of major organ transplantation.\n* History of malignancy within the past 5 years (except adequately treated low-risk cancers).\n* Clinically significant or uncontrolled cardiovascular, cerebrovascular, neurological, hepatic, renal, hematologic, or metabolic diseases.\n* Active or uncontrolled infections, including tuberculosis (active or untreated latent), hepatitis B or C, human immunodeficiency virus (HIV), or other clinically significant infections.\n* Active or severe neuropsychiatric conditions that may interfere with study participation.\n* Uncontrolled hypertension or clinically significant electrocardiogram abnormalities (including prolonged QT interval).\n* Clinically significant abnormal laboratory findings at screening (e.g., severe cytopenias, impaired liver or renal function, or coagulation abnormalities).\n* Recent major surgery or planned surgery during the study period.\n* Recent use of investigational agents or participation in another clinical study within 4 weeks prior to enrollment.\n* Pregnant or breastfeeding women, or women of childbearing potential unwilling to use effective contraception during the study and for an appropriate period after the last dose.\n* Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.","18 Years","75 Years",{"count":56,"type":21},30,[58],"PHASE1","The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 administered alone or in combination with YK012 in participants with active or refractory systemic lupus erythematosus (SLE).\n\nThe main questions this study aims to address are:\n\n* Whether YKST02 alone or in combination with YK012 is safe and well tolerated in participants with active or refractory SLE\n* Whether YKST02 alone or in combination with YK012 demonstrates preliminary efficacy in treating SLE\n* What the PK and PD characteristics of YKST02 are when administered alone or in combination with YK012\n* Whether treatment with YKST02 induces anti-drug antibody responses\n\nParticipants will:\n\n* Receive intravenous infusions of YKST02 alone or in combination with YK012 according to the assigned cohort\n* Undergo safety assessments, including monitoring for adverse events\n* Provide blood samples for PK, PD, and immunogenicity analyses\n* Be followed for approximately 49 weeks to assess safety and efficacy",[27],"2026-04-02",{"date":63,"type":37},"2026-04-06",{"date":65,"type":21},"2026-05",{"date":67,"type":21},"2028-06-30",{"name":69,"class":44},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":45},"100629092","clinical-study-of-evm18001-in-the-treatment-of-refractory-autoimmune-diseases-100629092","NCT07470151","Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases","Exploratory Clinical Study of EVM18001 Injection in the Treatment of Active Refractory Systemic Lupus Erythematosus, Myasthenia Gravis and Scleroderma","Inclusion Criteria:\n\n1. Voluntarily sign the Informed Consent Form (ICF), which must be signed by the participant or their legal guardian.\n2. At the time of signing the ICF, the age must be between 18 and 70 years (inclusive), regardless of gender.\n3. At screening, peripheral blood B cells must be CD19 positive, and T cells must express CD7.\n4. Confirmed autoimmune diseases based on recognized diagnostic criteria, including:\n\n   * SLE: Diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) or 2019 European League Against Rheumatism (EULAR)\u002FACR criteria;\n   * MG: Diagnosed with MG according to the Myasthenia Gravis Foundation of America (MGFA) clinical classification;\n   * SSc: Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n5. History of autoimmune disease for at least 6 months before screening and meets any of the following criteria. Definitions of active refractory SLE, active refractory SSc, and active refractory MG are as follows:\n\n   * Definition of active refractory SLE: SLEDAI-2000 score ≥6; and disease activity or relapse persists after at least 3 months of standard therapy (glucocorticoids combined with at least 2 immunosuppressants, or at least 1 imunosuppressant and 1 targeted therapy).\n   * Definition of active refractory SSc: Patients meeting the 2013 ACR\u002FEULAR classification criteria for SSc who still show disease activity or progression after at least 6 months of standard therapy (including steroids, immunosuppressants, vasodilators, or antifibrotic agents). Specific criteria include but are not limited to: mRSS increase ≥5 points or ≥25% from baseline; absolute value of predicted FVC% decrease ≥5%; DLCO% corrected for hemoglobin absolute value decrease ≥10%; new or worsening digital ulcers after ≥3 months of vasodilator therapy; persistent or recurrent organ involvement requiring intensified treatment.\n   * Definition of active refractory MG: Refers to generalized MG patients meeting MGFA diagnostic criteria with ongoing disease activity (MGFA II-IV, QMG ≥12, or MG-ADL ≥6), and includes at least one of the following: poor control after at least 12 months of standard therapy (including at least 2 immunosuppressants); need for ≥2 intravenous immunoglobulin (IVIG) or plasma exchange treatments in the past 12 months to control symptoms; relapse with prednisone ≥20 mg\u002Fday or reduction to \\\u003C10 mg\u002Fday; persistent or recurrent disease activity.\n6. Patients must meet the following conditions for concomitant medication:\n\n   1. Corticosteroids must have been used for more than 6 weeks prior to screening and at a stable dose of ≤ 10 mg\u002Fday prednisone or equivalent for at least 14 days prior to administration of EVM18001. Concurrent treatment with topical or inhaled corticosteroids (or other immunomodulators) is allowed;\n   2. Continued use during treatment is allowed if antimalarial drugs (eg, hydroxychloroquine, chloroquine, etc.) are started ≥ 12 weeks prior to screening and maintained at a stable dose for ≥ 8 weeks (maximum dose limit: hydroxychloroquine, 400 mg\u002Fday; chloroquine, 500 mg\u002Fday).\n7. Examination at screening meet any of the following criteria:\n\n   * SLE: positive for blood ANA, and\u002For positive for anti-dsDNA, anti-Smith antibodies;\n   * MG: Positive serology for anti-AChR antibodies or anti-musclespecific tyrosine kinase receptor (MuSK) antibodies.\n8. Life expectancy greater than 6 months.\n9. Bone marrow reserve and organ function are normal:\n\n   * Bone marrow function: defined as absolute neutrophil count (ANC) ≥ 1.0×109\u002FL, absolute lymphocyte count (ALC) ≥0.5×109\u002FL, hemoglobin (Hb) ≥80g\u002FL, platelet count (PLT) ≥50×109\u002FL. Blood transfusions and growth factors must not be used to meet these requirements within 7 days prior to screening for eligibility.\n   * Coagulation function: defined as international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5× upper limit of normal (ULN).\n   * Cardiac function: defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiography (ECHO).\n   * Pulmonary function: defined as Common Terminology Criteria ≤for Adverse Events (CTCAE) Grade 1 dyspnea and oxygen saturation (SpO2) ≥ 92% (pulse oximetry) on room air.\n   * Hepatic function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN, total bilirubin \\\u003C 2.0mg\u002FdL (total bilirubin of Gilbert syndrome trial participants \\\u003C3.0mg\u002FdL).\n   * Renal function: defined as calculated creatinine clearance (Cockcroft-Gault) ≥ 50 mL\u002Fmin without hydration assistance.\n10. Female trial participants of childbearing potential:\n\n    * Negative serum β human chorionic gonadotropin (β-hCG) test at screening;\n    * Agree to use a highly effective method of contraception for the duration of study participation and for 12 months after EVM18001 last infusion.\n11. Male trial participant whose partner is of childbearing potential who agrees to use a highly effective method of contraception during the study and 12 months after the last infusion of the EVM18001.\n\nExclusion Criteria:\n\n1. Concurrent autoimmune diseases requiring systemic treatment.\n2. The autoimmune disease meets the following criteria:\n\n   * SLE: patients with renal crisis;\n   * MG: MGFA clinical classification type V or experiencing myasthenic crisis;\n   * SSc: involving lungs and exist severe ILD and severe PAH, or patients with scleroderma renal crisis.\n3. Any of the following conditions exist:\n\n   * Positive for Hepatitis B surface antigen (HBsAg)\u002Fcore antibody (HBcAb)\u002Fe-antibody (HBeAb)\u002Fe antigen (HBeAg);\n   * Positive for Hepatitis C virus (HCV) antibody;\n   * Positive for human immunodeficiency virus (HIV) antibody;\n   * Positive CMV DNA or above the upper limit of detection;\n   * Positive for syphilis antigen or antibody.\n4. Other uncontrolled active infections exist at screening.\n5. Creatinine clearance \\\u003C50 mL\u002Fmin.\n6. Estimated glomerular filtration rate \\\u003C45 mL\u002Fmin\u002F1.73m² (calculated using the MDRD creatinine equation from the Chronic Kidney Disease Epidemiology Collaboration; or serum creatinine \\>2.0 mg\u002FdL.\n7. History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation.\n8. History within 6 months before screening of any of the following cardiovascular diseases: NYHA class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease.\n9. History of ≥grade 2 bleeding within 4 weeks before screening, or requiring long-term continuous anticoagulant therapy (such as warfarin, low molecular weight heparin, or factor Xa inhibitors, etc.).\n10. History within the past 24 weeks\u002F6 months of severe active central nervous system disease or pathology, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions\u002Fseizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric disorders. Stable patients will be assessed by the investigator for eligibility.\n11. Diagnosed with malignant tumors within the past 5 years. The following are excluded: non-melanoma skin cancer treated with radical therapy, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.\n12. History of live vaccine administration within the past 4 weeks.\n13. Have received any of the following treatments:\n\n    * Preventive therapy with short-acting oral antiretroviral drugs within 7 days before first administration, or preventive therapy with longacting antiretroviral drugs within 2 years before first administration;\n    * Plasma exchange, plasmapheresis, or hemodialysis within 14 days before screening;\n    * Any other clinical study drug within 4 weeks before screening. However, if the study treatment was ineffective or the disease progressed, and at least 3 half-lives had passed before screening, enrollment is allowed;\n    * History of bone marrow transplantation, gene therapy, adoptive cell therapy, or any type of CAR-T cell therapy;\n    * Previously received any mRNA-LNP product or other LNP-based drugs.\n14. Unable to complete washout of previous treatment drugs as required within 4 weeks before first administration, or unable to maintain stable doses of concomitant medications for autoimmune diseases.\n15. Pregnant or breastfeeding women.\n16. Allergic to supportive medications required for managing CAR-T cell therapy toxicities (e.g., tocilizumab).\n17. Other situations where the investigator judges that the trial participant has poor compliance or is unwilling or unable to adhere to the study protocol.","70 Years",{"count":79,"type":21},12,[24],"A FIH, single arm, open-label, Investigator Initiated Trial (IIT) study to evaluate the safety and tolerability of EVM18001 in the treatment of active refractory autoimmune diseases (SLE, MG, and SSc), and determine the recommended dose for subsequent treatment. At the same time, the PK\u002FPD characteristics of EVM18001 will be evaluated, preliminary efficacy will be observed, and related biomarkers and immunogenicity will be explored.",[27,83,84],"Scleroderma","Myasthenia Gravis (MG)",[86,87,83,88,89,90],"Active Refractory Systemic Lupus Erythematosus","Myasthenia Gravis","EVM18001","CAR-T","Refractory Autoimmune Diseases","RECRUITING","2026-03-10",{"date":94,"type":37},"2026-03-13",{"date":96,"type":21},"2026-03-12",{"date":98,"type":21},"2027-12",{"name":69,"class":44},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":45},"100617126","ace1831-in-adult-subjects-with-relapsedrefractory-systemic-lupus-erythematosus-sle-100617126","NCT07314567","ACE1831 in Adult Subjects With Relapsed\u002FRefractory Systemic Lupus Erythematosus （SLE）","An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed\u002FRefractory Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n* Male or female 18 to 60 years (inclusive)\n* History of meeting the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) criteria, or the 1997 ACR criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC)\n* Presence of anti-dsDNA antibodies and\u002For anti-nuclear antibodies (ANA) and\u002For anti-Smith (anti-Sm) antibodies positive\n* SLE is in the moderate to severe active phase with the SLEDAI-2000 score ≥ 8\n* At least one British Isle Lupus Rating Group Index (BILAG-2004) Class A (severe manifestation) or two Class B (moderate manifestation) organ scores, or both\n* Inadequate response to glucocorticoids and at least 2 of treatments used for at least 3 months\n* Women of childbearing potential and their partners must agree to use at least 1 highly effective method of contraception throughout the study period and for 1 year after treatment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe lupus nephritis requiring prohibited medications for active nephritis treatment，or hemodialysis, or eGFR \\\u003C 50 ml\u002Fmin\u002F1.73m²\n* Central nervous system disease caused by SLE or other conditions\n* Significant medical history that would pose a risk to the patients safety from the investigator's opinion, or patients medical condition could worsen during the study\n* Malignancies within 5 years\n* Presence of active, recurrent, chronic infection requiring treatment , or latent infection (HBV, HCV, HIV, TB, syphilis)\n* Received any B-cell depletion biologic therapy\n* Received immunosuppressive small molecule drug therapy， or other systemic corticosteroid therapy ， or prednisone\n* Pregnant or lactating women","60 Years",{"count":109,"type":21},22,[24],"ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Relapsed\u002FRefractory Systemic lupus erythematosus (SLE)",[27],[114,115,116,117],"ACE1831","SLE","Refractory Systemic lupus erythematosus (SLE)","gamma delta T (gdT) cell","2025-12-17",{"date":120,"type":37},"2026-01-02",{"date":122,"type":21},"2026-01-01",{"date":124,"type":21},"2027-12-31",{"name":126,"class":44},"Tongji Hospital"]