[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sle":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,48,75,102,129,154,183,207,233,260,284,306,329,347],{"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":26,"conditions":27,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100580644","phase-1-cd19-directed-chimeric-antigen-receptor-autologous-t-cells-cart19-for-lupus-100580644",false,"NCT06839976","CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus","CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Adolescents and Young Adults With Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Signed informed consent form must be obtained prior to any study procedure. Labs or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required window.\n2. Patient age must be 12-29 years, inclusive, at time of enrollment.\n3. Meeting ACR\u002FEULAR Classification Criteria for SLE\n4. ANA positive \\> 1:80 and\u002For double-stranded DNA (dsDNA) positive\n5. Active (refractory) disease, defined as follows:\n\n   a. Lupus nephritis subjects must meet both the following criteria: i. ISN\u002FRPS active nephritis Class III\u002FIV +\u002F- V lupus nephritis diagnosed by biopsy within past 12 months.\n\nii. Persistent and clinically significant: ≥2 measurements with urine protein with either of the following:\n\n1. \\> 1mg\u002Fmg creatinine\n2. \\> 0.5 mg\u002Fmg creatinine associated with renal dysfunction or low albumin.\n3. \\> 0.5 mg\u002Fmg creatinine in a patient with rising proteinuria after prior complete renal response b. Non-renal SLE subjects must meet either of the following criteria: i. SLEDAI-2K ≥ 8 and clinical SLEDAI-2K ≥ 6 ii. Inability to decrease prednisone ≤7.5mg\u002Fday or 0.15mg\u002Fkg\u002Fday, whichever is lower, due to active disease.\n\n6\\. Patients must have had at least 3 months of cumulative conventional therapy defined as:\n\n1. Conventional induction immunosuppressive agent(s) (e.g., mycophenolate mofetil, cyclophosphamide), and\n2. At least one additional therapy:\n\ni. B-cell directed biologic therapy (e.g., rituximab, belimumab, ofatumumab, obinutuzumab) ii. Calcineurin inhibitor (e.g., tacrolimus, cyclosporine, voclosporin) iii. Other immunosuppressive medication for SLE (e.g., anifrolumab, abatacept, JAK inhibitor) 7. Adequate organ function status\n\n1. Renal: eGFR must be ≥30 and subject cannot be receiving dialysis.\n2. Hepatic: Transaminases \\\u003C 5x upper limit of normal and serum conjugated (Direct) bilirubin \\\u003C1.5x upper limit of normal unless attributable to SLE. If attributable to autoimmune disease, Child-Pugh score must be class A or class B. Child-Pugh score cannot be class C.\n3. Cardiac: Shortening fraction \\> 28%, left ventricular ejection fraction \\>45%, and no evidence of severe pulmonary hypertension\n4. Pulmonary: Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \\\u003CGrade 3 hypoxia; DLCO ≥40% (corrected for anemia and\u002For VA volume if necessary) if PFTs are clinically appropriate as determined by the treating investigator.\n\n   8\\. Subjects of reproductive potential must agree to use acceptable birth control methods.\n\nExclusion Criteria:\n\n1. Active, untreated infections\n2. HIV infection\n3. Active Hepatitis B\n\n   a. Patients must have a negative hepatitis B surface antigen to be enrolled on this study.\n4. Active Hepatitis C\n5. Patients with severe neuropsychiatric lupus or neurologic manifestations of SLE (e.g. stroke, seizure, psychosis, demyelinating syndromes, organic brain syndrome, or lupus related headaches)\n6. Monogenic lupus (known)\n7. Previous autologous or allogenic stem cell transplant\n8. Previous kidney transplant\n9. History of seizure disorder\n10. Patients who are on anti-epileptic therapy\n11. Participation in a clinical trial in which the patient receives an investigational drug within a time period equal or less than 5.5 half-lives of the investigational agent prior to study enrollment.\n12. Subjects who are unwilling or unable to discontinue immunosuppressive medications at the times of CART19 infusion will be excluded from the trial\n13. Any comorbidity that in the opinion of the investigators would jeopardize the ability of the subject to tolerate therapy.\n14. Pregnant patients. All participants of childbearing potential must have negative pregnancy test.\n15. Lactating participants who want to continue breastfeeding.\n16. Patients who are unwilling to consent to LTFU","ALL","12 Years","29 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a single-center, single-arm, open-label phase 1\u002F2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE).\n\nPhase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.",[28,29,30,31,32,33,34],"SLE","Systemic Lupus Erythematosus (SLE)","CAR T Cell","CART19","Cell Therapy","Lupus","Lupus Nephritis (LN)","RECRUITING","2026-06-11",{"date":38,"type":39},"2026-06-15","ACTUAL",{"date":41,"type":39},"2025-05-06",{"date":43,"type":21},"2030-02-28",{"name":45,"class":46},"Children's Hospital of Philadelphia","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100563222","phase-1-a-study-of-cln-978-a-subcutaneously-administered-cd19-directed-t-cell-engager-in-subjects-with-systemic-lupus-erythematosus-100563222","NCT06613360","A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus","A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n* Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR \u002F ACR Classification Criteria at screening.\n* Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN.\n* Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening.\n* Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or biologic standard-of care agent.\n* If on corticosteroid and\u002For antimalarial, the dose must be stable prior to day 1.\n* Laboratory parameters including the following:\n\n  * Absolute lymphocyte count (ALC) ≥0.5 x 109\u002FL\n  * Peripheral B cell count ≥25 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥1.0 x 109\u002FL\n  * Hemoglobin ≥8 g\u002FdL\n  * Platelet count ≥75 x 109\u002FL.\n  * Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL\u002Fmin\u002F1.73m2\n  * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN\n* Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.\n\nExclusion Criteria:\n\n* Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.\n* Considered at high risk for thrombosis.\n* Rapidly progressive glomerulonephritis, and\u002For urine protein\u002Fcreatinine \\>3 mg\u002Fmg (339 mg\u002Fmmol).\n* Active severe neuropsychiatric\u002FCNS manifestations of SLE.\n* Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.\n* History of splenectomy.\n* Prior treatment with the following:\n\n  * Cellular or gene therapy product directed at any target.\n  * Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1.\n  * Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1.\n  * Non-biologic DMARD within 14 days prior to Day 1.\n  * Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day 1.\n* Live or attenuated vaccine within 28 days prior to screening or during screening.\n* Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1.\n* Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.\n* Any condition for which, in the opinion of the Investigator and\u002For Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment.","18 Years","70 Years",{"count":20,"type":21},[24],"Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).",[28,61],"SLE (Systemic Lupus)",[63],"Systemic Lupus Erythematosus","2026-06-04",{"date":66,"type":39},"2026-06-05",{"date":68,"type":39},"2025-01-21",{"date":70,"type":21},"2027-12",{"name":72,"class":73},"Cullinan Therapeutics Inc.","INDUSTRY",20,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100612999","phase-2-a-multicenter-randomized-double-blind-placebo-controlled-phase-2a-study-with-an-open-label-extension-evaluating-the-efficacy-and-safety-of-vent-03-in-adult-participants-with-active-cutaneous-lupus-erythematosus-with-or-without-systemic-lupus-erythematosus-100612999","NCT07260877","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus","AERIS","Key Inclusion Criteria:\n\n* Cutaneous lupus:\n\n  * CLASI-A score ≥8;\n  * At least 1 active discoid lupus erythematosus (DLE) lesion, OR at least 1 active subacute CLE lesion\n* If participant has previous SLE diagnosis:\n\n  * Positive antinuclear antibody test at Screening by immunofluorescent assay at the central laboratory with titer ≥ 1:80;\n  * Meets the American College of Rheumatology\u002F European Alliance of Associations for Rheumatology 2019 criteria for SLE; and\n  * Currently receiving at least one of the specified SLE medication treatments, at stable doses.\n\nKey Exclusion Criteria:\n\n* Meet protocol-specified infection or lab criteria; any other laboratory test results that, in the investigator's opinion, might place participant at unacceptable risk for participating in this study;\n* Moderate or severe liver impairment as classified by the Child-Pugh criteria (categories B and C);\n* Has drug-induced lupus, rather than 'idiopathic' lupus;\n* History of, or current, inflammatory joint or skin disease other than SLE and cutaneous lupus;\n* Diagnosis of select potentially confounding autoimmune disorders\n* Active severe or unstable neuropsychiatric SLE;\n* Hospitalization for a severe lupus flare in the past 3 months, or active severe SLE-driven disease, including lupus nephritis, for which in the opinion of the PI the protocol-specified SOC is insufficient;\n* History of or current diagnosis of anti-phospholipid syndrome;\n* History of any non-lupus disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to Day 1;\n* Meets protocol specified medical history of infectious diseases and infections and\u002For opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within specified timeframes;\n* Cancer screening results suspicious of malignancy or history of cancer within time specified with exceptions for curative therapy for squamous or basil cell carcinoma and cervical cancer in situ; and\n* Meets protocol specified exclusions related to concomitant medications.","80 Years",{"count":20,"type":21},[25],"The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to answer are:\n\n* Does VENT-03 affect the activity and severity of CLE?\n* What side effects do participants have when taking VENT-03?\n\nResearchers will compare VENT-03 to a placebo (a look-alike substance that contains no drug) to see if VENT-03 works to treat patients with CLE.\n\nParticipants will:\n\n* Take VENT-03 or a placebo for 4 weeks, then all participants will switch to VENT-03 for another 8 weeks;\n* Visit the clinic once a month for checkups and tests.",[87,63,28,61,88],"Cutaneous Lupus Erythematosus (CLE)","CLE",[90,91],"CLE, SLE, lupus, cutaneous lupus erythematosus, systemic lupus erythematosus, VENT-03","cGAS","2026-03-30",{"date":94,"type":39},"2026-04-06",{"date":96,"type":39},"2025-12-03",{"date":98,"type":21},"2026-09",{"name":100,"class":73},"Ventus Therapeutics U.S., Inc.",27,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":47},"100575717","early-phase-1-clinical-study-on-targeted-cd19bcma-car-t-therapy-for-autoimmune-diseases-100575717","NCT06775912","Clinical Study on Targeted CD19\u002FBCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×109\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×109\u002FL, lymphocyte count \\>0.3×109\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after RD06-04 reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of RD06-04 and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":109,"type":21},18,[111],"EARLY_PHASE1","This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG",[28,114,115,116,117,118,119],"Systemic Sclerosis","IIM","NMOSD","MS","MG","ANCA Associated Vasculitis (AAV)","2026-01-30",{"date":122,"type":39},"2026-02-02",{"date":124,"type":39},"2025-01-03",{"date":126,"type":21},"2027-06-01",{"name":128,"class":73},"Nanjing Bioheng Biotech Co., Ltd.",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100620959","phase-1-efficacy-and-safety-of-crc01-in-participants-with-severe-refractory-systemic-lupus-erythematosus-100620959","NCT07364396","Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus","An Open-label, Multi-center, Single-arm Phase 1\u002F2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus","CRC01-02","Inclusion Criteria:\n\n* Age 19 years or older, voluntarily provides written informed consent.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria.\n* Positive antinuclear antibody (ANA) at screening (titer ≥1:80).\n* Diagnosis of lupus nephritis Class III or IV (with or without concurrent Class V), confirmed by kidney biopsy within 1 year prior to screening based on ISN\u002FRPS 2018 criteria.\n* Inadequate response to, or intolerance of, at least two or more standard therapies for 6 months or longer (cyclophosphamide, mycophenolate mofetil, azathioprine, tacrolimus, rituximab, belimumab).\n* Proteinuria at screening with urine protein-to-creatinine ratio (UPCR) \\>1.5.\n* Adequate laboratory values at screening: Hemoglobin \\>8.0 g\u002FdL; ANC \\>1,000\u002FμL; Platelets ≥50,000\u002FμL; Total bilirubin ≤2.0 × ULN; AST and ALT ≤3 × ULN; eGFR ≥30 mL\u002Fmin\u002F1.73 m².\n* Hemodynamically stable, no pericardial effusion, and LVEF ≥50% by echocardiogram at screening.\n* FEV1\u002FFVC ≥70% at screening.\n* Willing and able to comply with study visits, procedures, and requirements.\n* Women of childbearing potential and men must agree to use effective contraception for at least 1 year after CRC01 infusion until PCR testing confirms clearance of CRC01.\n\nExclusion Criteria:\n\n* Current or anticipated requirement for renal dialysis during the study.\n* History of kidney transplantation or planned transplantation during the study.\n* History of severe CNS lupus or currently active severe CNS lupus.\n* Prior CAR-T cell therapy.\n* History of malignancy except for: basal or squamous cell carcinoma of skin treated and disease-free ≥3 years; in-situ carcinoma of cervix or breast treated and disease-free ≥3 years; superficial bladder cancer treated and disease-free ≥3 years; completely resected primary malignancy in complete remission ≥5 years.\n* Unstable angina and\u002For myocardial infarction within 1 year prior to screening.\n* Congestive heart failure of NYHA Class III or IV within 1 year prior to screening.\n* Thromboembolism, pulmonary embolism, or clinically significant bleeding diathesis within 6 months prior to screening.\n* Hypoxemia, clinically significant pleural effusion, or abnormal ECG findings within 6 months prior to screening.\n* Stroke (ischemic or hemorrhagic) within 6 months prior to screening.\n* Positive HBsAg; positive anti-HCV (eligible if HCV RNA negative); known HIV infection; or active neurological autoimmune\u002Finflammatory diseases (e.g., Guillain-Barré syndrome, ALS).\n* Recurrent or symptomatic ventricular tachycardia, or atrial fibrillation with rapid ventricular response despite therapy within 3 months prior to screening.\n* Severe or uncontrolled active infection requiring systemic therapy at screening.\n* Rapidly progressive disease or otherwise unsuitable for study participation, per investigator judgment.\n* Pregnant or breastfeeding women.\n* Known hypersensitivity to investigational product components.\n* Participation in another investigational study within 4 weeks prior to screening.\n* Receipt of systemic corticosteroids at therapeutic doses within 7 days prior to leukapheresis (≤7.5 mg\u002Fday prednisone equivalent is permitted).\n* Receipt of immunosuppressive agents within 7 days prior to leukapheresis.\n* Receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to leukapheresis.\n\nInclusion Criteria for CRC01 Infusion:\n\n* No clinically significant worsening of organ function after screening.\n* If any of the following adverse events related to lymphodepleting chemotherapy exceed Grade 1 or worsen compared with screening, CRC01 infusion must be delayed:\n\n  * Requirement for supplemental oxygen\n  * New arrhythmia symptoms or clinically significant changes in cardiac function compared with screening\n  * Hypotension requiring treatment\n  * Active infection within 72 hours prior to the planned CRC01 infusion\n\n    * If bacterial, viral, or fungal infection is documented, improvement of symptoms must be documented before infusion.\n* Women of childbearing potential must have a negative urine pregnancy test prior to infusion.\n* If CRC01 infusion is delayed for more than 2 weeks after lymphodepleting chemotherapy, administration may proceed only with approval from the sponsor's medical monitor.\n* No receipt of therapeutic doses of systemic corticosteroids or immunosuppressive agents within 7 days prior to CRC01 infusion. (Prednisone ≤7.5 mg\u002Fday or equivalent is permitted.)\n* No receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to CRC01 infusion.","19 Years",{"count":139,"type":21},39,[24,25],"The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE).\n\nThe main objectives of the study are:\n\n1. To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis.\n2. To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity.\n\nStudy Design This is a single-arm, open-label, multi-center, Phase 1\u002F2 study. All enrolled participants will receive CRC01 after screening and baseline assessments.\n\nStudy Procedures\n\nParticipants will:\n\n* Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments.\n* Provide autologous T lymphocytes through a procedure called leukapheresis.\n* Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy).\n* Receive a single intravenous infusion of CRC01 cells.\n* Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity.\n* Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response.\n\nKey Outcomes\n\nResearchers will measure:\n\n* Changes in proteinuria and kidney function.\n* Changes in disease activity scores.\n* Incidence and severity of adverse events.",[143,34,28,61],"Lupus Nephritis","NOT_YET_RECRUITING","2026-01-21",{"date":147,"type":39},"2026-01-23",{"date":149,"type":21},"2026-02",{"date":151,"type":21},"2030-06",{"name":153,"class":73},"Curocell Inc.",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":162,"minAge":55,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100604330","pregnancies-before-the-diagnosis-of-systemic-lupus-erythematosus-100604330","NCT07148115","Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus","Pregnancy Outcomes Prior to a Systemic Lupus Erythematosus Diagnosis","PREDILUP","Inclusion criteria:\n\n* Women of childbearing age with a history of at least one pregnancy\n* Pregnancy occurred before the diagnosis of LES.\n* LES was diagnosed after at least one pregnancy.\n* The subject is classified as having LES according to the 1997 ACR or EULAR 2019 criteria.\n\nExclusion criteria:\n\nLES was previously diagnosed prior to any conception.","FEMALE","55 Years",{"count":165,"type":21},50,"OBSERVATIONAL","This is an observational, monocentric, retrospective cohort study. Its primary objective is to examine maternal and foetal outcomes in pregnancies that occurred before the diagnosis of systemic lupus erythematosus (SLE) in a group of female participants who were subsequently diagnosed with the condition.",[169,28],"Pregnancy Complications",[171,28,172],"Pregnancy","Obstetrical events","2025-12-26",{"date":175,"type":39},"2025-12-31",{"date":177,"type":39},"2025-01-01",{"date":179,"type":21},"2026-04-30",{"name":181,"class":46},"University of Algiers",2,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":162,"minAge":55,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":196,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":47},"100530145","phase-1-a-study-of-apg-2575-in-patients-with-mild-to-moderate-systemic-lupus-erythematosus-100530145","NCT06182969","A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.","A Randomized, Double-blind, Placebo-controlled Phase I\u002FII Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.","Inclusion Criteria:\n\n* 1\\. Diagnosis of systemic lupus erythematosus for at least 6 months.\n* 2\\. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.\n* 3\\. SLEDIA-2000 score: 4-12\n* 4.Other than systemic lupus erythematosus, subject should be in general good health.\n\nExclusion Criteria:\n\n* 1\\. Severe systemic lupus erythematosus.\n* 2\\. Significant autoimmune disease other than lupus.\n* 3\\. Significant, uncontrolled or unstable disease in any organ.","65 Years",{"count":192,"type":21},40,[24,25],"To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).",[28],[28,197],"APG-2575","2025-12-14",{"date":200,"type":39},"2025-12-16",{"date":202,"type":39},"2024-08-09",{"date":204,"type":21},"2026-12",{"name":206,"class":73},"Ascentage Pharma Group Inc.",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":223,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":47},"100601220","early-phase-1-safety-and-efficacy-of-ont01-in-lupus-100601220","NCT07107659","Safety and Efficacy of ONT01 in Lupus","Safety and Efficacy of ONTO1 in Lupus","Inclusion Criteria:\n\n1. ≥ 18 years old and able to provide informed consent to participate.\n2. Diagnosis of SLE and have fulfilled the ACR classification criteria for SLE during the course of their disease.\n3. Active non-renal SLE, with one active non-renal clinical manifestation, who have failed at least 1 disease modifying anti-rheumatic drug (DMARD) therapy (not including hydroxychloroquine and corticosteroids)\n\n   * Active non-renal SLE is defined as having a SLEDAI of 6 or greater (with at least 1 non-renal clinical domain) OR Active nephritis defined as having a no or partial response after initial induction and maintenance therapy with mycophenolate mofetil (and other standard of care therapies) for 3 months or more for class III, IV, IV, V (or combination) nephritis.\n   * Active LN is defined as follows: a. kidney biopsy showing Class III, IV, V, III+V, or IV+V, within 1 year from screening, AND b. 24-hour urine protein\u002Fcreatinine ratio \\>=1g\u002Fg at screening, AND c. absence of partial renal response (PRR)\n   * Partial renal response (PRR) is defined as a. 24-hour UPCR improved by \\>=25% after 3 months from the start of induction standard of care (SOC) therapy (baseline), or \\>= 50% after 6 months from the induction therapy (UPCR), AND b. 24-hour UPCR\\\u003C2g\u002Fg if baseline was \\\u003C 3g\u002Fg, OR \\\u003C 3g\u002Fg if baseline at induction was \\>= 3g\u002Fg. AND d. EGFR\\>=60 ml\u002Fmin\u002F1.73 M2 or no less than 80% of Baseline eGFR (at induction) AND e. No intercurrent rescue therapy, death, or early SOC treatment discontinuation or study withdrawal No response (NR) is defined as a. no achievement of at least a partial renal response, OR b. use of intercurrent rescue therapy, OR c. death\n4. Female patients who are women of childbearing potential must agree to use a highly effective form of contraception during the study and for at least 120 days after last exposure to study drug. Male patients with female partners of childbearing potential must use effective barrier contraception (i.e., condoms) during the study and for at least 120 days after last exposure to study drug. Also, patients may not proceed with sperm or egg donation during the study and for at least 120 days after the last exposure to study drug\n\nExclusion Criteria:\n\n1. Any condition, including any uncontrolled disease (eg, asthma, interstitial lung disease, pulmonary arterial hypertension, morbid obesity), that in the Sponsor-Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation.\n2. Active central nervous system SLE associated with significant cognitive impairment leading to inability to provide informed consent and\u002For comply with the protocol.\n3. Comorbidities requiring systemic corticosteroid (CS) therapy, such as asthma or inflammatory bowel disease. Systemic is defined as oral, rectal or any injectable route of administration (thus stable dosing by other routes is allowed, including inhaled, topical, ophthalmic, otic, and intranasal).\n4. Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of or during the Screening Visit, or completion of oral anti-infectives within 2 weeks before or during the Screening Visit.\n5. History of positive human immunodeficiency virus (HIV), hepatitis C antibody and\u002For polymerase chain reaction, hepatitis B surface antigen (HBsAg) (+), and\u002For hepatitis B core IgG and\u002For IgM antibody (+) at the Screening Visit.\n6. History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection (LTBI), determined by a positive QuantiFERON test at the Screening Visit\n7. History of malignancy (hematologic or solid tumor) within 10 years prior to Screening Visit, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or adequately treated carcinoma in situ\u002Fcervical intraepithelial neoplasia of the uterine cervix.\n8. Immunization with live or live-attenuated vaccines within 1 month before or during the Screening period.\n9. Initiation of, or change in, dosing of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker within 2 weeks before the Screening Visit or during the Screening period.\n10. Treatment with Voclosporin or Cyclophosphamide at time of screening.\n11. Treatment with other investigational agents within the last 3 months or 5 half-lives, or as per washout requirement from the previous protocol, whichever is longest, prior to the Screening Visit.\n12. Clinically significant abnormalities in laboratory tests, unless attributable to active SLE at the Screening Visit\n\n    * Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level \\> 2.5 × upper limit of normal (ULN), or\n    * Total bilirubin \\> 1.5 × ULN, or\n    * Hemoglobin \\\u003C 5.0 mmol\u002FL \\[9 g\u002FdL\\], or\n    * White blood cells \\\u003C 2.5 × 109\u002FL, or\n    * Absolute neutrophil count \\\u003C 1500 \u002Fmm3, or\n    * Platelets \\\u003C 75 × 109\u002FL\n13. Clinically significant chest imaging (e.g. X-ray, computed tomography or magnetic resonance imaging \\[MRI\\]) abnormalities per Sponsor-Investigator opinion (e.g. interstitial lung disease) or evidence of active TB on chest X-ray. Chest imaging study must have been performed in 3 months prior to the Screening Visit or during the Screening period.\n14. Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n15. Patients are unable or unwilling to adhere to the contraception requirements outlined in inclusion criteria 4.",{"count":215,"type":21},61,[111],"ONT01 is a drug that is being studied for the treatment of Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) and is not approved by the FDA. The purpose of this study is to better determine whether ONT01 is safe and tolerated by people with lupus nephritis or SLE. The study also looks at how the administration of ONT01 in combination with widely used treatments given for lupus, including the medication mycophenolate mofetil and others, can improve symptoms of lupus. A total of 61 participants will be enrolled in this study.",[34,219,220,221,33,28,63,222],"Lupus Nephritis - WHO Class III","Lupus Nephritis - WHO Class IV","Lupus Nephritis - World Health Organization (WHO) Class III","Systemic Lupus Erythematosus (Disorder)",[143,33,28],"2025-11-19",{"date":226,"type":39},"2025-11-20",{"date":228,"type":21},"2026-09-04",{"date":230,"type":21},"2030-05",{"name":232,"class":46},"Hospital for Special Surgery, New York",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":47},"100608580","early-phase-1-a-study-of-anti-cd19bcma-universal-car-t-cell-therapy-rd06-05-in-patients-with-autoimmune-diseases-100608580","NCT07203404","A Study of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Aged ≥18 years and ≤75 years.\n3. Adequate organ function defined as:\n\n   1. Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500\u002FμL, absolute lymphocyte count (ALC) ≥100\u002FμL, hemoglobin (Hb) ≥80 g\u002FL, and platelet count (PLT) ≥50,000\u002FμL. Transfusions and growth factors must not have been used within 7 days prior to screening to meet these criteria.\n   2. Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), and total bilirubin \\\u003C1.5 × ULN (or \\\u003C3.0 × ULN for subjects with Gilbert's syndrome).\n   3. Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.\n   4. Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).\n4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test. Females who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.\n5. From the time of signing the informed consent form until 6 months after the completion of RD06-05 infusion, female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective methods of contraception.\n\nInclusion Criteria for Subjects with Anti-GBM Disease:\n\nDiagnosis of anti-GBM disease according to the 2012 Chapel Hill Consensus Conference definitions, meeting both of the following criteria:\n\n1. Positive for anti-GBM antibody (based on historical or screening test results);\n2. Evidence of renal involvement at screening, defined as:\n\n   1. Presence of active, pathologically confirmed anti-GBM disease (renal biopsy must have been performed within 1 year prior to the screening visit or during the screening period); and\n   2. Accompanied by proteinuria and hematuria.\n\nInclusion Criteria for Subjects with SLE\u002FLN:\n\n1. Diagnosis of SLE according to the 2019 European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.\n2. Positive for antinuclear antibody (ANA), and\u002For anti-double-stranded DNA (anti-dsDNA) antibody, and\u002For anti-Smith (anti-Sm) antibody at screening.\n3. SLEDAI-2K score \\> 6 points at screening.\n\nInclusion Criteria for Subjects with AAV\u002FAAGN:\n\n1. Diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis.\n2. Positive for anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody at screening or based on historical testing.\n3. For AAV without renal involvement: A Birmingham Vasculitis Activity Score (BVAS) version 3 score of ≥3 at screening, indicating active vasculitis.\n\nInclusion Criteria for Subjects with MN:\n\n1. Diagnosis of primary (idiopathic) membranous nephropathy confirmed by renal biopsy pathology (the renal biopsy must have been performed within 2 years prior to screening or during the screening period).\n2. Meeting the criteria for high-risk or relapsed\u002Frefractory membranous nephropathy:\n\nHigh-risk patients, defined as meeting any of the following criteria:\n\n1. Normal eGFR with urine protein \\>3.5g\u002F24h, a reduction of \\\u003C50% in urine protein after 6 months of ACEI\u002FARB treatment, and serum albumin \\\u003C25 g\u002FL or anti-PLA2R antibody \\>50 RU\u002FmL;\n2. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² and\u002For urine protein \\>8g\u002F24h for more than 6 months.\n\nRefractory\u002FRelapsed patients:\n\nRefractory patients are defined as those resistant to prior immunosuppressive therapy (persistent urine protein ≥3.5g\u002F24h with a \\\u003C50% reduction from baseline).\n\nRelapsed patients are defined as those who achieved complete or partial remission with prior immunosuppressive therapy but subsequently developed recurrent urine protein ≥3.5g\u002F24h.\n\nInclusion Criteria for Subjects with SSC:\n\n1. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria.\n2. Diagnosis of diffuse cutaneous SSc at screening.\n\nInclusion Criteria for Subjects with IIM:\n\n1.Diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, corresponding to a probability score of ≥55%). The subtypes include dermatomyositis (DM), anti-synthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).\n\nExclusion Criteria:\n\n1. Subjects with SLE\u002FLN:\n\n   1. Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs\u002Fsymptoms associated with neuropsychiatric lupus, as assessed by a qualified specialist during screening.\n   2. Drug-induced or secondary lupus.\n2. Subjects with AAV\u002FAAGN:\n\n   1. Drug-induced or secondary AAV\u002FAAGN.\n   2. Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.\n3. Subjects with Anti-GBM Disease:\n\n   1. Anuria for more than 7 days.\n   2. Dialysis dependence for more than 30 days.\n   3. Ongoing moderate or severe pulmonary hemorrhage (or cessation within the past two weeks) defined as pulmonary hemorrhage requiring assisted ventilation, supplemental oxygen, or blood transfusion.\n   4. Symptomatic congestive heart failure (NYHA Class 2-4) requiring prescription medication or clinically significant cardiogenic peripheral edema.\n4. Subjects with MN:\n\n   Secondary membranous nephropathy.\n5. Subjects with IIM:\n\n   Presence of severe rhabdomyolysis or CK level ≥120 × ULN at screening.\n6. Subjects with SSc:\n\n   1. History of scleroderma renal crisis within 1 year prior to screening.\n   2. History of cardiac tamponade within 6 months prior to screening.\n   3. Active infection of digital ulcers within 3 months prior to screening.\n   4. Presence of digital gangrene at screening.","75 Years",{"count":242,"type":21},84,[111],"An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19\u002FBCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE\u002FLN, AAV\u002FAAGN, Anti-GBM, MN, SSc, and IIM).",[28,246,247,248,249,250,251,115],"LN","ANCA Associated Vasculitis","ANCA-Associated Glomerulonephritis","Anti-GBM Disease","MN","SSc","2025-09-23",{"date":254,"type":39},"2025-10-02",{"date":256,"type":39},"2025-07-24",{"date":258,"type":21},"2028-07-23",{"name":128,"class":73},{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":240,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":47},"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.",{"count":268,"type":21},10,[24],"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.",[28,33,272,63,29],"Systemic Lupus Erthematosus",[274,28,33],"systemic lupus erythematosus","2025-09-04",{"date":277,"type":39},"2025-09-11",{"date":279,"type":39},"2025-01-07",{"date":281,"type":21},"2026-07",{"name":283,"class":73},"LiveKidney.Bio",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":4},"100604429","association-of-serum-interleukin-33-levels-with-clinical-manifestations-in-systemic-lupus-erythematosus-100604429","NCT07149402","Association of Serum Interleukin-33 Levels With Clinical Manifestations in Systemic Lupus Erythematosus","Serum Interleukin-33 (IL-33) Levels and Their Association With Clinical Manifestations in Patients With Systemic Lupus Erythematosus and Lupus Nephritis at Assiut University Hospital","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Diagnosed with systemic lupus erythematosus according to the American College of Rheumatology (ACR) criteria.\n* For the lupus nephritis group: confirmed diagnosis of lupus nephritis based on clinical, laboratory, and renal biopsy findings.\n* For the control group: healthy individuals matched for age and sex, with no history of autoimmune or renal diseases.\n\nExclusion Criteria:\n\n* Patients with other autoimmune diseases. Patients with chronic infections or malignancies. Pregnant or lactating women. Patients with end-stage renal disease (ESRD) or on dialysis. Individuals who refuse to provide informed consent.",{"count":292,"type":21},150,"This is a case-control study investigating serum IL-33 levels and their association with clinical manifestations in systemic lupus erythematosus (SLE). The study compares IL-33 levels in three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and healthy controls. The goal is to clarify IL-33's role as a biomarker reflecting disease activity and organ involvement, especially renal pathology.",[28],[28,296],"IL-33","2025-08-28",{"date":299,"type":39},"2025-09-02",{"date":301,"type":21},"2026-08-30",{"date":303,"type":21},"2027-12-30",{"name":305,"class":46},"Assiut University",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":313,"sex":162,"minAge":55,"maxAge":4,"enrollmentInfo":314,"targetDuration":316,"studyType":166,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":4},"100583112","assessment-of-blood-indices-in-systemic-lupus-erythematosus-100583112","NCT06872086","Assessment of Blood Indices in Systemic Lupus Erythematosus","Assessment of Blood Indices As Predictors of Disease Activity in Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Patients aged 18 years or older diagnosed with SLE according to the 2019 ACR\u002FEULAR classification criteria.\n* Healthy controls without any autoimmune diseases or significant comorbidities\n\nExclusion Criteria:\n\n* • Patients with other autoimmune diseases (e.g., rheumatoid arthritis, Sjögren's syndrome).\n\n  * Recent infections or acute inflammatory conditions.\n  * Individuals with hematological disorders unrelated to SLE (e.g., leukemia, lymphoma).",true,{"count":315,"type":21},70,"1 Month","This case-control study aims to explore the relationship between specific blood indices (lymphocyte-monocyte ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammatory index) and disease activity in patients with systemic lupus erythematosus (SLE).\n\nThe study includes 70 SLE patients and 70 healthy controls, matched for age and gender, recruited from Assiut University Hospital.\n\nDisease activity is assessed using the SLEDAI-2K score, and blood indices are analyzed to determine correlations with disease activity.",[28,319],"Blood Indices",[28,63,319],"2025-03-07",{"date":323,"type":39},"2025-03-12",{"date":325,"type":21},"2025-05-01",{"date":327,"type":21},"2026-12-30",{"name":305,"class":46},{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":335,"maxAge":55,"enrollmentInfo":336,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":4},"100560736","evaluating-mental-health-challenges-in-juvenile-lupus-erythematosus-and-their-caregivers-100560736","NCT06581029","Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers","Inclusion Criteria:\n\n1. Age from 11 to 18 years\n2. Both sex\n3. diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis.\n4. Met the New ACR and EULAR criteria for classification of SLE .\n\nInclusion criteria of the control healthy group : 1- no history of psychiatric and medical disease 2-Intelligence quotation more than 70.\n\nExclusion Criteria:\n\n1. No history of psychiatric illness prior to the diagnosis of lupus.\n2. Intelligence quotation more than 70.","11 Years",{"count":337,"type":21},62,"assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.",[28],"2025-01-31",{"date":342,"type":39},"2025-02-04",{"date":344,"type":21},"2025-06-01",{"date":327,"type":21},{"name":305,"class":46},{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":47},"100475410","argentinian-prospective-registry-of-patients-with-lupus-100475410","NCT05470569","Argentinian Prospective Registry of Patients With Lupus","Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology","Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Classified as SLE (according to the 1982\u002F1997 American College of Rheumatology criteria and\u002For Systemic Lupus International Collaborating Clinics criteria for SLE)\n* Less than 5 years from meeting SLE criteria\n* Informed consent signature\n\nExclusion Criteria:\n\n* Diagnosis of other systemic autoimmune diseases or overlap syndromes\n* Patients who have been transferred to other centers",{"count":355,"type":21},1500,"In Latin America, information about patients with systemic lupus erythematosus (SLE) is limited. Multicenter studies are needed to obtain \"real world data '' and to carry out longer follow-ups. The purpose of this project is to design a cohort of Argentinian patients with SLE to describe \"our real setting\" and to identify possible limitations in access to specialized consultations and treatments.",[28],"2022-07-20",{"date":360,"type":39},"2022-07-22",{"date":362,"type":39},"2022-04-01",{"date":364,"type":21},"2027-04-01",{"name":366,"class":46},"Sociedad Argentina de Reumatologia"]