[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-lupus-erythematosus-sle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-lupus-erythematosus-sle":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,62,0,25,[9,59,88,114,147,178,199,224,251,275,297,333,371,408,432,457,478,516,538,560,579,601,626,650,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100618504","phase-3-a-study-of-enpatoran-in-participants-with-cutaneous-manifestations-of-lupus-with-or-without-systemic-disease-100618504",false,"NCT07332481","A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease","A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)","ELOWEN-1","Inclusion Criteria\n\n* Vaccinations are up to date according to local guidelines\u002Frecommendations. Recombinant zoster vaccination is encouraged but not mandatory.\n* Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and\u002For Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).\n* Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.\n* Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and\u002For SCLE and\u002For ACLE.\n\nFor participants with SLE:\n\n* Participants with diagnosis of SLE and fulfill EULAR\u002FACR 2019 classification criteria.\n* Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening.\n* Participants with CLASI-A score \\>= 8 at Screening and Day 1 visits.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria\n\n* Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.\n* Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor\u002Fdesignee's opinion constitutes inappropriate risk or contraindication for participation.\n* Participants with drug-induced lupus (SLE or CLE).\n* Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).\n* Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\\>) 339 milligrams per millimole (mg\u002Fmmol), and\u002For estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL\u002Fmin\u002F1.73 m\\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.\n* Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.\n* Other protocol-defined exclusion criteria may apply.","ALL","18 Years","75 Years",{"count":22,"type":23},202,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:\n\nStudy Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.\n\nIntervention Form: Film-coated tablet.",[29,30],"Systemic Lupus Erythematosus (SLE)","Cutaneous Lupus Erythematosus (CLE)",[32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Toll-like Receptor 7","Toll-like Receptor 8","Adults","SLE","CLE","Lupus","Discoid lupus erythematosus (DLE)","Subacute Cutaneous Lupus Erythematosus (SCLE)","M5049","Enpatoran","Cutaneous manifestations","Lupus erythematosus","Acute cutaneous lupus erythematosus (ACLE)","Interferon gene signature","RECRUITING","2026-07-01",{"date":49,"type":50},"2026-07-02","ACTUAL",{"date":52,"type":50},"2026-03-10",{"date":54,"type":23},"2029-05-24",{"name":56,"class":57},"EMD Serono Research & Development Institute, Inc.","INDUSTRY",11,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":19,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":24,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100518621","phase-1-double-blind-placebo-controlled-study-to-evaluate-the-effect-of-nad-boosting-with-nicotinamide-riboside-on-immunometabolism-and-immunity-in-systemic-lupus-erythematosus-100518621","NCT06032923","Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nSLE subjects:\n\n* Female subjects 18 years or older who meets \\> 3 of 11 modified Am. Coll. of Rheumatology (ACR) (1997) Revised Criteria for SLE and mild\u002Fmoderate disease activity defined as an SLE Disease Activity Index 2000(SLEDAI 2K) between zero and less than or equal to 14 at screening;\n* If on glucocorticoids, the dose must be less than or equal to 20 mg daily and stable for at least 4 weeks prior to screening;\n* If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, dose must have been stable for the 12 weeks prior to screening. The max. allowed doses - hydroxychloroquine 400 mg\u002Fday, chloroquine phosphate 500 mg\u002Fday and quinacrine 100 mg\u002Fday;\n* If on immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus); dose must have been stable for the 12 weeks prior to screening\n* Subjects of childbearing potential must agree to practice effective birth control for the duration of the study;\n* Stated willingness to comply with all study procedures and availability for the duration of the study;\n* Agreement to adhere to Lifestyle Considerations throughout study duration;\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* If on vitamin B3 or tryptophan supplementation at screening, willing to stop it at least 6 weeks before the baseline visit.\n\nControl subjects:\n\n* Female subjects 18 years or older\n* No history of autoimmune or inflammatory disease\n* If on vitamin B3 or tryptophan supplementation at screening, willing to stop it at least 6 weeks before the blood draw visit.\n\nEXCLUSION CRITERIA:\n\nSLE Subjects:\n\n* Active renal or central nervous system disease or major renal or hepatic dysfunction;\n* Treatment with rituximab, belimumab or any other biologic agent within the 6 months prior to screening\n* Treatment with cyclophosphamide or IVIG within the 6 months prior to screening and or increase in glucocorticoid dose within 4 weeks of screening;\n* Pregnancy or lactation (nursing)\n* Treatment with another investigational drug or other intervention within 6 months of screening\n\nControl Subjects:\n\n* Inability to sign consent\n* Pregnancy or nursing\n\nPregnant women are excluded from participation on this study. Self-reported pregnancy status may be accepted from female control participants of child-bearing potential for a blood draw which is considered a minimal risk procedure.",true,"FEMALE","120 Years",{"count":69,"type":23},78,[71,72],"PHASE1","PHASE2","Study Description:\n\nSystemic lupus erythematosus (SLE) occurs predominantly in women and is driven by type I interferon dysregulation and neutrophil hyperresponsiveness. Neutrophils in females have reduced mitochondrial bioenergetic capacity which affects immunometabolism. Nicotinamide adenine dinucleotide (NAD)+ boosting with nicotinamide riboside blunts type 1 IFN activation in-vivo in monocytes of healthy subjects and ex-vivo in SLE subjects. These findings support the proposal of the hypothesis that NAD+ boosting by NR supplementation will modulate metabolic pathways in lupus and blunt type 1 interferon signaling. Moreover, as type 1 interferon drives endothelial dysfunction, linked to increased cardiovascular risk, the effect of NR on endothelial function will be examined.\n\nObjectives:\n\nPrimary Objective: Evaluate the effect of NR vs. placebo on immunometabolic and inflammatory remodeling in female SLE subjects:\n\nExploratory Objective: Compare and characterize myeloid cell bioenergetic and immunometabolic profiles in healthy control and SLE female subjects\n\nEndpoints:\n\nPrimary Endpoint:\n\nThe primary end point will be to assess the effect of NR on blunting type I IFN signaling by measuring monocytic secretion of IFN-beta secretion compared to baseline in response to placebo vs. NR supplemented in SLE study subjects.\n\nExploratory Endpoints:\n\nHealthy control vs. SLE subjects:\n\n* Compare type I IFN transcript profiles in monocytes and neutrophils at baseline and in response to activation.\n* Assess cell bioenergetics including: 1) monocyte and neutrophil metabolic flux mass spectroscopy of 13C-glucose and 13Cglutamine analysis to investigate their metabolic fates; (iii) Mitochondrial oxygen consumption (using glucose, amino acid, and fatty acid substrates) and glycolysis rates.\n\nSLE baseline vs. NR\u002Fplacebo supplementation:\n\nBaseline vs. 6 weeks of NR\u002Fplacebo:\n\n-Assess effect of NR on bioenergetics by measuring steady-state metabolite levels comparing changes in placebo vs. NR groups in monocytes and neutrophils.\n\nBaseline vs. 12 weeks of NR\u002Fplacebo:\n\n* Whole blood NAD+ levels (batched and measured at the end of study enrollment period)\n* Explore effects of NR on gene regulation using monocyte and neutrophils by RNA-seq and chromatin remodeling analysis.\n* Determine the effect of NR vs placebo on endothelial dysfunction in SLE subjects",[75],"Systemic Lupus Erythematosus (Sle)",[37,77],"Chronic Inflammation","2026-06-30",{"date":47,"type":50},{"date":81,"type":50},"2024-03-13",{"date":83,"type":23},"2028-08-01",{"name":85,"class":86},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100540241","interstellar---international-study-evaluating-lupus-outcomes-after-anifrolumab-real-world-use-100540241","NCT06314282","INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use","INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice","INTERSTELLAR","Inclusion Criteria:\n\n1. Aged 18 years or older at study enrolment.\n2. Fulfilled the 2019 EULAR\u002FACR criteria1 for SLE at the time of study entry.\n3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.\n4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.\n5. In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.\n6. Provided informed consent to participate in the study.\n7. Willing and able to participate in all required study evaluations and procedures.\n\nExclusion Criteria:\n\n1. Currently participating in an anifrolumab early access\u002Fcompassionate use program or an interventional clinical trial with an investigational product.\n2. Previous exposure to anifrolumab as part of a clinical trial or early access program.\n3. Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \\[MMF\\]\u002Fcyclophosphamide \\[CYC\\] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.\n4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.",{"count":97,"type":23},200,"OBSERVATIONAL","INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion\u002Fexclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.",[29],[35,102,103,37,104],"Systemic lupus erythematosus","autoimmune disease","Anifrolumab","2026-06-29",{"date":78,"type":50},{"date":108,"type":50},"2024-10-22",{"date":110,"type":23},"2027-12-31",{"name":112,"class":57},"AstraZeneca",32,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":65,"sex":18,"minAge":122,"maxAge":19,"enrollmentInfo":123,"targetDuration":4,"studyType":24,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":146},"100645085","model-early-immunologic-stages-of-pediatric-hematological-pre-lupus-100645085","NCT07680010","Model Early Immunologic Stages of Pediatric Hematological Pre-lupus","Model Early Immunologic Stages of Pediatric Hematological Pre-lupus in Order to Prevent SLE in Children.","PRELUDE","* Inclusion criteria:\n\n  * For patients :\n\n    * Child or adolescent with newly diagnosed ITP or SLE according to the specific definitions of ITP or SLE, prior to any treatment,\n    * Over 1 and under 18 years of age at diagnosis, weighing more than 7 kg.\n    * Written consent from parents or guardians,\n    * Patient affiliated to a social security scheme.\n  * For controls :\n\n    * Over 1 and under 18 years of age at diagnosis, weighing more than 7 kg.\n    * Follow-up in the day hospital at the Bordeaux University Hospital, for a condition that does not affect the immune system\n    * Matched on age,\n    * Written consent from parents or guardians,\n    * Patient affiliated to a social security scheme\n* Exclusion criteria:\n\n  * For patients :\n\n    * ITP secondary to a known cause: previous or concomitant immune deficiency, bone marrow or organ transplantation, other autoimmune disease, Evans syndrome (autoimmune hemolytic anemia or autoimmune neutropenia present at ITP diagnosis) or cancer with immunosuppressive therapy.\n    * Treatment with immunomodulation or immunosuppressants (including immunoglobulins, corticoids, hydroxychloroquine), started prior to inclusion (day of sampling).\n    * Pregnant women, women in labour and breastfeeding women\n  * For controls :\n\n    * Suffering from an immunological disease,\n    * Infection within fifteen days prior to inclusion,\n    * Immunomodulatory therapy.\n    * Pregnant women, women in labour and breastfeeding women","1 Year",{"count":124,"type":23},105,[126],"NA","Immunologic thrombocytopenic purpura (ITP) in children is a pre-lupus condition if associated with the presence of anti-nuclear antibodies (ANA), providing a unique model for understanding the natural history of autoimmunity, particularly that of systemic lupus erythematosus (SLE). We will describe the shared and\u002For unique immunological pathways involved at diagnosis in 70 children with ITP and in 20 children with SLE, and compare them between ITP-ANA- (more often transient), ITP-ANA+ (pre-lupus condition, more often persistent) and SLE",[129,29],"Immune Thrombocytopenic Purpura ( ITP )",[131,132,133,134,135],"Children","Immunologic Thrombocytopenic Purpura","Anti-Nuclear Antibody","Systemic Lupus Erythematosus","Biomarkers","NOT_YET_RECRUITING","2026-06-25",{"date":47,"type":50},{"date":140,"type":23},"2026-07",{"date":142,"type":23},"2033-10",{"name":144,"class":145},"University Hospital, Bordeaux","OTHER",2,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":157,"conditions":158,"keywords":167,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":176,"locationsCount":87},"100638972","periodontal-disease-in-rare-renal-disorders-perio-ra-re-100638972","NCT07575347","Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)","Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease","PERIO-RA-RE","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent\n* At least 10 natural teeth present\n* Belonging to one of the predefined study groups:\n\n  1. Alport syndrome (genetically or clinically confirmed)\n  2. Fabry disease (enzymatically or genetically confirmed)\n  3. Tuberous sclerosis complex (according to established clinical or genetic criteria)\n  4. Systemic lupus erythematosus defined according to the 2019 EULAR\u002FACR or SLICC 2012 classification criteria, with renal involvement defined by at least one of the following: \\[1\\] Biopsy-proven lupus nephritis, \\[2\\] Persistent proteinuria (\\>0.5 g\u002Fday or equivalent), \\[3\\] Active urinary sediment (hematuria and\u002For cellular casts) consistent with lupus nephritis\n  5. Chronic kidney disease (CKD) of non-rare etiology: defined according to KDIGO criteria (eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m² and\u002For markers of kidney damage)\n  6. Individuals without CKD, recruited from clinical or dental care settings as non-CKD controls\n\nExclusion Criteria:\n\n* Periodontal treatment within the last 6 months\n* Antibiotic therapy within the last 4 weeks\n* Pregnancy\n* Conditions precluding periodontal examination\n* Inability to comply with study procedures",{"count":156,"type":23},100,"This study aims to evaluate the burden and phenotypic spectrum of periodontal disease in patients with rare kidney disorders (such as Alport syndrome, Fabry disease, and tuberous sclerosis complex) and systemic lupus erythematosus (SLE), compared with chronic kidney disease (CKD) controls and population controls.\n\nThis is a cross-sectional, case-control observational study. Participants will undergo a single structured evaluation including a full-mouth periodontal examination, a clinical questionnaire, and collection of relevant clinical and nephrological data.\n\nThe primary objective is to compare the prevalence of periodontitis across study groups. Secondary objectives include characterization of periodontal disease severity, prevalence of gingivitis and xerostomia, and identification of disease-specific oral phenotypes.\n\nExploratory analyses will assess associations between periodontal disease and clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.",[159,160,161,162,163,164,165,166,29],"Periodontal Disease","Periodontitis","CKD","Chronic Kidney Disease","Alport Syndrome","Fabry Disease","Lupus or SLE","Tuberous Sclerosis Complex (TSC)",[159,160,161,168,169,134,166,162],"Rare Kidney Diseases","Alport syndrome","2026-06-24",{"date":172,"type":50},"2026-06-26",{"date":174,"type":50},"2026-05-04",{"date":110,"type":23},{"name":177,"class":145},"Stefan Lujinschi",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":24,"phases":188,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":87},"100588828","early-phase-1-universal-anti-cd70-car-t-cht101-cell-therapy-for-relapsed-refractory-systemic-lupus-erythematosus-100588828","NCT06946485","Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus","A Clinical Study of the Safety and Efficacy of Universal Anti-CD70 CAR-T (CHT101) for the Treatment of Relapsed and Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Meet the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE).\n2. SLEDAI-2000 score \\>6.\n3. Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.\n4. Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg\u002Fkg\u002Fday) combined with cyclophosphamide and ≥1 of the following immunosuppressants for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine A, and\u002For biologics (e.g., rituximab, belimumab, telitacicept).\n5. Aged 18-65 years; both genders eligible.\n6. Adequate organ function:Bone marrow function: White blood cell count ≥3×10⁹\u002FL. Absolute neutrophil count ≥1×10⁹\u002FL (without colony-stimulating factor therapy within 2 weeks prior to testing). Hemoglobin ≥60 g\u002FL; Liver function: Alanine aminotransferase (ALT) ≤3×upper limit of normal (ULN). Aspartate aminotransferase (AST) ≤3×ULN. Total bilirubin (TBIL) ≤1.5×ULN (except Gilbert's syndrome, TBIL ≤3.0×ULN); Renal function: Creatinine clearance (CrCl) ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula); Coagulation: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN; Cardiac function: Hemodynamic stability with left ventricular ejection fraction (LVEF) ≥55%.\n7. Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication. Females of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be lactating.\n8. Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.\n\nExclusion Criteria:\n\n1. Presence of neuropsychiatric lupus (NPSLE).\n2. History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).\n3. History of severe drug allergies or hypersensitivity.\n4. Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).\n5. Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.\n6. Severe cardiac diseases.\n7. Congenital immunoglobulin deficiency.\n8. History of malignancy (except non-melanoma skin cancer, in situ cervical\u002Fbladder\u002Fbreast\u002Fthyroid carcinoma with disease-free survival \\>5 years).\n9. End-stage renal failure.\n10. Participants meeting any of the following: Hepatitis B surface antigen (HBsAg)-positive or hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA; Hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; HIV antibody-positive; Syphilis-positive (RPR and TPHA positive, or TPHA positive with RPR reconfirmed positive after 4 weeks).\n11. Psychiatric disorders or severe cognitive impairment.\n12. Participation in other clinical trials within 3 months prior to enrollment.\n13. Pregnant women or those planning pregnancy.\n14. Other conditions deemed by the investigator to preclude study participation.","65 Years",{"count":187,"type":23},15,[189],"EARLY_PHASE1","This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.",[29],{"date":105,"type":50},{"date":194,"type":50},"2025-04-02",{"date":196,"type":23},"2027-03",{"name":198,"class":145},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":66,"minAge":19,"maxAge":67,"enrollmentInfo":206,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":87},"100482835","gonadotropin-releasing-hormone-agonist-gnrha-in-ovarian-preservation-in-sle-subjects-receiving-cyclophosphamide-as-determined-by-questionnaires-100482835","NCT05567198","Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires","Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires","* ELIGIBILITY CRITERIA:\n* INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone\n\nSLE females \\\u003C40 years at the beginning of CYC treatment without GnRH-a cotreatment.\n\n-EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone\n\nFemales \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs).\n\n-INCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg\u002Fmonth or 11.25mg\u002Fevery 3 months.\n\nSLE females \\\u003C40 years at the beginning of CYC treatment with GnRH-a cotreatment.\n\n-EXCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg\u002Fmonth or 11.25mg\u002Fevery 3 months.\n\nFemales \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated STIs.\n\n-Group: Control subjects.\n\nAge-matched female SLE patients without a history of reproductive disorders, infertility, or untreated STIs, who have not received CYC either with or without GnRH-a.",{"count":156,"type":23},"Background:\n\nSystemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not.\n\nObjective:\n\nTo find out whether GnRHa can help protect women s ovaries during CYC.\n\nEligibility:\n\nWomen under age 40 years starting CYC treatment with or without GnRHa.\n\nDesign:\n\nThis study will do 2 things: It will conduct patient surveys. It will collect data from medical records.\n\nParticipants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked about their history of pregnancy or infertility.\n\nParticipants can take the survey in 4 ways:\n\nOn paper, sent through the mail.\n\nOnline, in a secure web page managed by the NIH.\n\nBy phone.\n\nIn person, during a routine visit to the NIH clinic.\n\nThe survey will take about 30 minutes.\n\nParticipants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments.\n\nResearchers will also collect data about participants reproductive history. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections.",[75,209],"Primary Ovarian Insufficiency (Poi)",[209,211,212,213,214],"Nephritis","Neuro-Psychiatric Lupus","Anti-Mullerian Hormone (Amh)","Natural History","2026-06-17",{"date":217,"type":50},"2026-06-18",{"date":219,"type":50},"2023-03-03",{"date":221,"type":23},"2027-05-31",{"name":223,"class":86},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":24,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":87},"100580644","phase-1-cd19-directed-chimeric-antigen-receptor-autologous-t-cells-cart19-for-lupus-100580644","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","12 Years","29 Years",{"count":234,"type":23},24,[71,72],"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.",[35,29,238,239,240,37,241],"CAR T Cell","CART19","Cell Therapy","Lupus Nephritis (LN)","2026-06-11",{"date":244,"type":50},"2026-06-15",{"date":246,"type":50},"2025-05-06",{"date":248,"type":23},"2030-02-28",{"name":250,"class":145},"Children's Hospital of Philadelphia",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":259,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100606417","a-study-in-participants-with-active-systemic-lupus-erythematosus-with-inadequate-response-to-glucocorticoids-and-2-immunosuppressants-100606417","NCT07175285","A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants","Prospective, Observational Study in Participants With Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and At Least 2 Immunosuppressants","BENCHMARK-SLE","Inclusion Criteria:\n\n* Participants must have signed and dated an Institutional Review Board\u002F Independent Ethics Committee (IRB\u002FIEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines\n* Participants must be ≥16 years of age at the time of signing the ICF\n* Meet the European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus (SLE)\n* Have an inadequate response to glucocorticoids and ≥ 2 immunosuppressant therapies, one of which is a biologic therapy consistent with treatment guidelines, used for at least 3 months each. Eligibility is regardless of prior hydroxychloroquine or any anti-malarial treatment. Inadequate response is defined as a lack of response, insufficient response, or lack of sustained response after at least 3-month treatment with appropriate doses of a standard of care agent. Intolerance or contraindication may be considered as inadequate response provided it is documented and confirmed acceptable by the Adjudication Committee\n* Have active disease at study entry when signing ICF, defined as:\n\n  * ≥ 1 British Isles Lupus Assessment Group Index (BILAG) A OR ≥ 1 BILAG B with history of SLE manifestations that would qualify for a BILAG A within the last 24 months, AND\n  * Positive autoantibodies (at least one) to confirm diagnosis of SLE: Antinuclear antibody ≥1:160, anti-dsDNA, anti-Sm, anti-Ro (SSA), anti-La (SSB), or low complement proteins (C3 or C4)\n* Participants with lupus nephritis (LN) meeting the study eligibility criteria must have had a renal biopsy per standard of care within 6 months (± 30 days) prior to signing the ICF, indicating the presence of active Class III or IV LN (alone or in combination with Class V) according to the 2018 Revised International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS), with \\\u003C 60% interstitial fibrosis and tubular atrophy \\\u003C 60% global glomerulosclerosis\n\nExclusion Criteria:\n\n* Pregnant women\n* Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial\n* Participant is unwilling or unable to comply with routine clinical follow-up necessary for collection of study data","16 Years",{"count":261,"type":23},223,"The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response to glucocorticoids and at least two immunosuppressants",[29],[265],"Systemic lupus erythematosus (SLE)","2026-06-10",{"date":242,"type":50},{"date":269,"type":50},"2025-10-08",{"date":271,"type":23},"2032-10-05",{"name":273,"class":57},"Bristol-Myers Squibb",64,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":282,"targetDuration":4,"studyType":24,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":296},"100565814","phase-1-a-study-to-evaluate-the-safety-and-activity-of-sar448501dr-0201-in-patients-with-autoimmune-rheumatic-diseases-100565814","NCT06647069","A Study to Evaluate the Safety and Activity of SAR448501\u002FDR-0201 in Patients With Autoimmune Rheumatic Diseases","A Phase 1, Open-label, Multiple Ascending Dose Basket Study to Evaluate the Safety and Activity of SAR448501\u002FDR-0201 in Patients With Select Autoimmune Rheumatic Diseases","Inclusion Criteria:\n\n* Diagnosis of SLE and\u002For RA. American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria should be used.\n* Contraception during the study intervention period and for at least 140 days after the last administration of study intervention: Male participants must agree to refrain from donating or cryopreserving sperm, and either be abstinent or use contraception\u002Fbarrier. Female participants must use of a highly effective contraceptive measure for all females of childbearing potential. Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to the first dose.\n* Specific to Systemic Lupus Erythematosus (SLE):\n\n  * Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥8 at screening with at least 4 points from clinical features at screening.\n  * At least 1 British Isles Lupus Assessment (BILAG) A score or 1 BILAG B score at screening\n  * Positive ANA (titer ≥1:80) as documented in the participant's medical history\n  * Positive for any of the following as documented in the participant's medical history: antidsDNA, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies\n  * Inadequate response to systemic glucocorticoids and to at least 1 therapy other than antimalarials for at least 12 weeks including: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.\n* Specific to Rheumatoid Arthritis (RA):\n\n  \\-- Moderate-to-severe disease activity as defined by a 28-joint disease activity score using C reactive protein (DAS28-CRP) \\>3.2 at screening.\n* Inadequate response or intolerance to at least 2 disease-modifying antirheumatic drugs (DMARDs, at least 1 biologic \\[bDMARD\\] or targeted synthetic \\[tsDMARD\\]) after a minimum of 12 weeks treatment duration.\n* At least 6 tender joints at screening.\n* At least 6 swollen joints at screening.\n* Methotrexate (MTX) for at least 12 consecutive weeks, and at a stable dose of ≤25 mg\u002Fweek oral or SC since at least 4 weeks prior to randomization, OR - in case of MTX intolerance - conventional DMARDs at a stable dose for at least 28 days.\n* If taking MTX, compliant with folic acid 1 mg daily or 5 mg weekly or greater in combination with MTX.\n\nExclusion Criteria:\n\n* Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require interventions that will affect investigational drug PD.\n* Receipt of super-high potency (eg, clobetasol propionate, betamethasone dipropionate) or high potency (eg, fluocinonide, methylprednisolone aceponate) topical corticosteroids within 28 days prior to screening, had dose changes in other topical corticosteroids within 14 days prior to Day 1, or had dose changes in nonsteroidal topical immunosuppressants within 28 days prior to Day 1.\n* Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, calcineurin inhibitors, JAK inhibitors, or azathioprine within 28 days prior to Day 1.\n* Receipt of any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \\>20 mg\u002Fday, abatacept.\n* Receipt of any mAb or experimental immunomodulator within 28 days or 5 published half-lives prior to Day 1, whichever is longer.\n* Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1.\n* Receipt of rituximab or other B cell depleting biologics without return of CD19 or CD20 count to above the LLN.\n* Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, CAR-T or T cell vaccination therapy.\n* Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection.\n* History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.\n* Active infection or a history of serious infections as defined in the protocol.\n* Surgery within 28 days prior to Day 1.\n* 12-lead ECG parameters after 10 minutes resting in supine position NOT in the defined normal ranges.\n* Evidence of significant, uncontrolled concurrent disease that could affect compliance with the study (eg, chronic obstructive pulmonary disease).\n* Diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.\n* High dose of antimalarial or a change in dose within 28 days prior to Day 1.\n* Receipt of systemic corticosteroids \\>20 mg\u002Fday (prednisone or equivalent) or had dose changes of systemic corticosteroids within 28 days prior to Day 1.\n* Documented liver disease including documented diagnosis of cirrhosis.\n* Participants with a history of hypercoagulation event or thrombosis (such as venous thromboembolism, pulmonary embolism, or stroke), or participants who have known hypercoagulation risk factors (including antiphospholipid syndrome), or participants currently on anticoagulation will be excluded.\n* Specific to SLE:\n\n  * Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis at screening.\n  * Known biopsy-proven diagnosis of lupus nephritis (any class) or otherwise unexplained proteinuria (0.5g protein\u002F24h; or urine protein\u002Fcreatinine ratio \\>0.5g\u002Fg) at screening.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":5,"type":23},[71],"This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501\u002FDR-0201.\n\nThe study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.",[29,286],"Rheumatoid Arthritis (RA)","2026-05-21",{"date":289,"type":50},"2026-05-22",{"date":291,"type":50},"2025-03-27",{"date":293,"type":23},"2029-06-25",{"name":295,"class":57},"Sanofi",7,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":24,"phases":308,"briefSummary":310,"conditions":311,"keywords":317,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":332},"100638937","phase-4-carotid-ultrasound-based-strategy-for-primary-prevention-of-cardiovascular-events-in-inflammatory-rheumatic-disease-prevener-100638937","NCT07611747","Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)","Randomized Clinical Trial to Assess the Efficacy and Safety of a Primary Prevention Strategy for Cardiovascular Events in Patients With Inflammatory Rheumatic Diseases Based on the Use of Carotid Ultrasound","PREVENER","Inclusion Criteria:\n\n1. Patients aged ≥50 years who have provided written informed consent.\n2. Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases:\n\n   * Rheumatoid arthritis (RA) according to ACR\u002FEULAR 2010 criteria\n   * Psoriatic arthritis (PsA) according to CASPAR criteria\n   * Axial spondyloarthritis (AxSpA) according to ASAS criteria\n   * Systemic lupus erythematosus (SLE) according to ACR\u002FEULAR 2019 criteria\n3. Low-to-moderate cardiovascular risk according to SCORE2\u002FOP classification.\n\nExclusion Criteria:\n\n1. Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk.\n2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice.\n3. Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe).","50 Years",{"count":307,"type":23},1944,[309],"PHASE4","PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD).\n\nPatients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2\u002FOP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment.\n\nPatients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2\u002FOP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \\\u003C55 mg\u002FdL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.",[286,312,313,29,314,315,316],"Psoriatic Arthritis (PsA)","Axial Spondy","Caridovascular Disease","Atherosclerosis","Carotid Artery Diseases",[318,319,320,321,322],"Carotid ultrasound","Carotid plaques","Subclinical atherosclerosis","Cardiovascular prevention","Inflammatory rheumatic diseases","2026-05-20",{"date":325,"type":50},"2026-05-28",{"date":327,"type":50},"2026-04-22",{"date":329,"type":23},"2031-12",{"name":331,"class":145},"Instituto de Investigación Marqués de Valdecilla",17,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":18,"minAge":231,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":24,"phases":342,"briefSummary":343,"conditions":344,"keywords":349,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":370},"100539833","phase-1-a-phase-1-study-of-ft819-in-b-cell-mediated-autoimmune-disease-100539833","NCT06308978","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease","Key Inclusion Criteria:\n\n* Age: 12 to 70 years old.\n* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.\n* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.\n* Health Status: Adequate organ function to tolerate treatment.\n* Consent: Able to provide informed consent or assent\u002Fobtain parental consent and comply with study procedures.\n\nKey Exclusion Criteria:\n\n* Pregnancy\u002FBreastfeeding: Women must not be pregnant or nursing.\n* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.\n* Active Infections: No recent or ongoing serious infections.\n* Recent Cancer or Prior Cell Therapy: No active\u002Frecent malignancies, prior CAR T-cell therapy, or organ transplant.\n* Allergies: No known allergies to study treatments.\n* Weight Restriction: Must weigh at least 50 kg (110 lbs).","70 Years",{"count":341,"type":23},244,[71],"This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.",[345,346,347,29,348],"Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)","Idiopathic Inflammatory Myositis (IIM)","Systemic Sclerosis (SSc)","Lupus Nephritis",[350,351,352,265,353,354,355,356,357,358,359,360,361,362,348],"FT819","Fate Therapeutics","Idiopathic inflammatory myositis (IIM)","Systemic sclerosis (SSc)","Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV)","Allogeneic CAR-T","CD19-Targeted Therapy","Cell Therapy for Autoimmune Diseases","B-Cell Depletion in Autoimmune Disease","Phase 1 Clinical Trial","Allogeneic CAR cells","Autoimmune Diseases","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases","2026-05-19",{"date":289,"type":50},{"date":366,"type":50},"2024-03-28",{"date":368,"type":23},"2042-09-30",{"name":351,"class":57},21,{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":378,"enrollmentInfo":379,"targetDuration":4,"studyType":24,"phases":381,"briefSummary":382,"conditions":383,"keywords":390,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":87},"100599529","phase-1-phase-1-study-of-hbi0101-car-t-in-refractory-b-cell-autoimmune-diseases-100599529","NCT07085676","Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases","A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age: 18\\~80 years old; for patients aged ≥ 75 years, geriatric assessment and endorsement are required;\n2. Diagnosis of B-cell mediated ARDs listed below:\n\n   SLE patients: individuals diagnosed with SLE according to American College of Rheumatology (ACR) and\u002For Systemic lupus international collaborating clinics (SLICC) classification criteria, who have severe and progressive disease course reflected by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of 8 or more. Eligible patients must have failed to at least one of the conventional DMARDs (azathioprine, methotrexate, mycophenolate mofetil or cyclophosphamide), one of the calcineurin inhibitors (tacrolimus or cyclosporin) and one of the biologic agents (belimumab, rituximab or aniflorumab), each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The failure is defined as:\n   * lack of response per SLEDAI-2k (\\\u003C4 points reduction from baseline) or no improvement in BILAG domains, or\n   * disease flare per SLEDAI-2k (≥4 points increase from baseline) or new BILAG A or ≥2 new BILAG B organ scores, or intolerance or discontinuation due to adverse effects.\n\n   SSc patients: Patients who were diagnosed with diffuse or limited cutaneous SSc according to the College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR-EULAR) classification criteria, with severe or rapidly progressive disease Eligible patients must meet any of the following criteria:\n   * Progression of skin thickening ≥ 12 over the past 6 months or Modified Rodnan skin score (mRSS) ≥15\n   * Any Medsger Disease Severity Score grade 3-4 in one major organ or grade ≥2 in two organs\n   * Progressive interstitial lung disease evidenced by HRCT or FVC \\\u003C80% or DLCO \\\u003C80%, or evidence of pulmonary function decline, defined as an absolute FVC decline of ≥ 10% , or FVC decline of 5% -9% combined with DLCO 15%.\n   * Other internal organ involvement.\n\n   Eligible patients must have failed to at least two state-of-the-art immunosuppressive therapies including MTX, MMF, cyclophosphamide, azathioprine, nintedanib, tocilizumab or rituximab; each therapy must have been administered for a minimum of 3 months, unless discontinued due to a contraindication or toxicity. The failure is defined as:\n   * lack of response in skin per mRSS (≤20% relative and ≤5 point absolute reduction from baseline) or no clinically meaningful improvement in FVC, DLCO, or other organ involved assessed by Medsger DSS, or\n   * disease flare in skin per mRSS (increase in mRSS ≥20% and ≥5 points from baseline) or decline in FVC ≥10% predicted or in DLCO ≥15% predicted from baseline, other major SSc complication, or\n   * intolerance or discontinuation due to adverse effects\n\n   IIM, including dermatomyositis, anti-synthetase syndrome, immune mediated necrotizing myopathy, and polymyositis: patients must be diagnosed with IIM according to the 2017 ACR\u002FEULAR Classification Criteria for idiopathic inflammatory myopathies.\n\n   Eligible patients must have active disease, defined by at least one of the following:\n   * CPK ≥4xULN\n   * Loss of muscle strength in the weakest muscle group for less than 80% per MMT8\n   * Evidence on MRI of active myositis within last 6 months\n   * Evidence on EMG of active myositis within last 6 months\n   * Muscle biopsy evidence of active myositis within last 6 months\n\n   Only patients with refractory disease will be recruited, defined as previous failure to (1) at least two of five non-glucocorticoids immunosuppressive therapies and (2) either rituximab or IVIG, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The five non-glucocorticoids therapies considered are azathioprine, MTX, MMF, IVIG, and rituximab The failure is defined as:\n   * lack of response in muscle strength per MMT-8 or CPK (\\\u003C20% relative improvement) or per MRI or\n   * disease flare in muscle strength per MMT-8 (≥30% decline) or CPK (≥30% rise) or objective worsening of other organ involvement per Myositis Disease Activity Assessment Tool or\n   * intolerance or discontinuation due to adverse effects\n\n   RA patients: Seropositive RA patients (positive for anti-cyclic citrullinated peptide and rheumatoid factor), diagnosed according to the 2010 ACR\u002FEULAR classification criteria.\n\n   Eligible patients must exhibit high disease activity (DAS28CRP ≥5.1), and be resistant to at least four conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARD) groups.\n\n   Each patient must have previously received at least one medication from each of the mentioned groups, including\n   * JAK-STAT inhibitors\n   * Anti-TNF agents\n   * Anti-IL6 drugs\n   * Anti-CTLA4-Ig treatments, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories\n\n   Drug resistance is defined as:\n   * Inadequate clinical response measured by composite score DAS28CRP (\\> 3.6) or failure to reach ACR20 or\n   * Disease progression measured by DAS28CRP (≥20% increase) or radiographic progression or\n   * Intolerance or discontinuation due to adverse effects\n\n   NMOSD: Patients must be diagnosis of AQP4-IgG-positive NMOSD based on the 2015 International Panel for NMOSD Diagnosis (IPND) criteria (Wingerchuk et al., 2015).\n\n   Eligible patients must have experienced at least two relapses in the past 24 months, with at least one occurring in the preceding 12 months before screening Each patients must have previously received with inadequate disease control (one or more clinical attacks, with new MRI activity, despite adequate treatment dosing) at least one immunosuppressant for at least 6 months (azathioprine or mycophenolate mofetil) and\u002For Rituximab for at least 3 months and\u002For a targeted therapy (eculizumab, inebilizumab, or satralizumab) or must have a contraindication to such treatment.\n\n   MS patients: must have confirmed history of diagnosis of primary progressive or secondary progressive MS .\n\n   Eligible patients must have: Expanded Disability Status Scale (EDSS) score between 3.0 and 8.5 and evidence of disease activity, defined by either clinical progression and\u002For radiological finding on MRI, such as new, enhancing or enlarging lesions in the last 12 months.\n\n   Eligible patient must have previously received at least one high efficacy drug and have been offered standard treatments and have experienced disease progression or lack of efficacy despite at least six months of treatment. These will include clinical activity (new relapse\\[s\\]), radiological activity (new or enlarging T2 lesions and\u002For gadolinium-enhancing lesions on MRI), or confirmed disability progression (an increase in least 1 point on the EDSS sustained for ≥6 months).\n\n   Eligible patient must have history of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression within the year prior to inclusion, irrespective to concurrent MRI activity.\n\n   MG patients must meet all the following criteria:\n\n   \\- Confirmed diagnosis of generalized MG, supported by positive autoantibodies (anti-AChR, anti-MuSK).\n\n   Disease Severity:\n   * Myasthenia Gravis Activities of Daily Living (MG-ADL) score of ≥6, with ocular symptoms constituting less than 50% of the total score.\n   * Myasthenia Gravis Foundation of America (MGFA) clinical classification of II to IV.\n\n   Eligible patients must have Refractory Status and meet at least one of the following criteria:\n   * No improvement or worsening myasthenic symptoms, with failure to achieve minimal manifestation status or meaningful improvement in MGFA class or MG-ADL score, or recurrent myasthenic exacerbations despite adequate immunosuppressive or immunomodulatory therapy for at least 6 months for all therapies and 3 months for B cell depletion therapy\n   * Improvement in Post-Intervention Status (PIS), but with an MG-ADL score ≥6 persisting for at least 4 months.\n   * Remission or improvement in PIS, but with ≥1 episode of disease exacerbation (MG-ADL ≥6) per year during tapering of immunotherapy medications.\n   * After experiencing a myasthenic crisis, patients who undergo multiple immunotherapies (e.g., intravenous immunoglobulin, plasma exchange, high-dose intravenous methylprednisolone), thymectomy, and active infection control but still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days.\n\n   Each patient must receive stable doses of medication prior to enrollment.\n\n   Refractory APLA patients: must have confirmed history of APLA, based on Sydney 2006 or ACR\u002FEULAR 2023 criteria\n\n   \\- Eligible patients must have medium to high-titer antiphospholipid antibodies, documented repeatedly (≥2 tests spanning 12 weeks) Eligible patients must have refractory disease: persistent or recurrent arterial thrombosis, venous thrombosis or diffuse alveolar hemorrhage despite conventional therapy with stable treatment with vitamin K antagonist anticoagulation (maintained at therapeutic stable dose keeping INR consistently within target range) and immunosuppression treatment including glucocorticoid, rituximab and Plaquenil\n3. AST\u002FALT below 5 times the upper limit of normal, blood bilirubin below 3 times the upper limit of normal ;\n4. Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \\>45%, normal to mild pulmonary hypertension, and the oxygen saturation is above 93% in the resting state without oxygen;\n5. No obvious active infection;\n6. There are no contraindications for blood collection;\n7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study;\n8. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n9. Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria\n\n1. CNS disease- History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-autoimmune progressive neurologic condition or PML\n2. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) or alkaline phosphatase (ALP) detection value is greater than 5 times the upper limit of normal (ULN); or total bilirubin test value greater than 3 times the upper limit of normal (ULN); Exceptional: liver function disturbance due to myositis.\n3. Cardiovascular disease: Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to leukapheresis\u002F moderate- severe pulmonary hypertension\u002F severe arrhythmia (ventricular tachycardia, ventricular fibrillation, high grade ventricular block) in the past 6 months; New York heart function class (NYHA) class III- Level IV or LVEF\\\u003C45%.\n4. Lung disease: patients with chronic lung disease with any of the following: \\* Oxygen saturation (SpO2) \\\u003C 90% on room air \\* FVC≤45% of predicted or DLCO≤40% of predicted at screening. \\* Evidence of pulmonary hypertension as defined as estimated RVSP\\> 50 mmHg.\n5. Muscle disease: evidence of any of the following: \\* Severe proximal muscle atrophy of upper or lower extremity on MRI or clinical examination. \\*Finding of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), or cancer-associated myositis (myositis diagnosed within 2 years of cancer).\n6. Other uncontrolled diseases: acute diseases (such as acute pneumonia or other infection, pulmonary embolism, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to indicated autoimmune diseases which in the judgment of the investigator may confound study results or place subjects at undue risk.\n7. Biologics therapy: Received rituximab within 4 months of expected CAR T treatment: No plasma exchange or immunoglobulin treatment within 4 weeks prior to screening. MS patients: No high dose corticosteroid treatment in the 30 days prior to enrollment; see also section 9.1 for the list of restrictions.\n8. Participated in any clinical study within 3 months prior to enrollment, or participate in other clinical investigations during the study period.\n9. Previous or concurrent malignancy with the following exceptions: Adequately treated basal cell or squamous cell carcinoma, in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening.\n10. Transplantation: History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002For bone marrow transplantation.\n11. Disease-specific criteria: MS\u002FNMO patients: No disease relapse in the 30 days prior to enrollment\n12. Known HIV positive status.\n13. Active hepatitis B or C infection.\n14. Active CMV infection\n15. Pregnant or lactating women.\n16. Inability to understand or follow the research protocol subject requirements.\n17. Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy","80 Years",{"count":380,"type":23},120,[71],"A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.",[347,384,286,29,385,386,387,388,389],"Idiopathic Inflammatory Myopathy (IIM)","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive","Neuromyelitis Optica Spectrum Disorder (NMOSD)","Myasthenia Gravis (MG)","Antiphospholipid Antibody Syndrome",[391,29,392,393,394,395,396,397,387,388,398],"B-cell mediated autoimmune rheumatic diseases","Systemic sclerosis (SSC)","Idiopathic inflammatory myopathy (IIM)","Rheumatoid arthritis (RA)","B-cell maturation antigen (BCMA)","Autologous CAR-T","Multiple sclerosis (MS) Primary and Secondary progressive","refractory antiphospholipid antibody syndrome","2026-04-29",{"date":401,"type":50},"2026-05-06",{"date":403,"type":50},"2024-09-01",{"date":405,"type":23},"2030-11-01",{"name":407,"class":145},"Polina Stepensky",{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":65,"sex":18,"minAge":415,"maxAge":416,"enrollmentInfo":417,"targetDuration":419,"studyType":98,"phases":4,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":430,"locationsCount":87},"100625676","early-myocardial-dysfunction-helps-identify-severe-refractory-pediatric-lupus-100625676","NCT07425730","Early Myocardial Dysfunction Helps Identify Severe Refractory Pediatric Lupus","Myocardial Dysfunction in Pediatric Lupus","Inclusion Criteria:\n\n* fulfill the American College of Rheumatology (ACR) criteria\n* disease onset at ages before 18 years\n\nExclusion Criteria:\n\n* patients with a history of concomitant malignancy\n* patients with active bacterial, viral, fungal, mycobacterial infection","7 Years","17 Years",{"count":418,"type":23},60,"6 Months","To investigate biomarkers to identify pediatric SR-SLE patients by non-invasive echocardiographic techniques.",[29],[423,424],"lupus","echocardiography",{"date":426,"type":50},"2026-04-28",{"date":428,"type":50},"2026-02-01",{"date":47,"type":23},{"name":431,"class":145},"Shanghai Jiao Tong University School of Medicine",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":65,"sex":18,"minAge":439,"maxAge":19,"enrollmentInfo":440,"targetDuration":4,"studyType":24,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":87},"100635664","mediterranean-diet-and-gut-microbiota-in-children-with-systemic-lupus-erythematosus-100635664","NCT07555626","Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus","Effects of a Mediterranean Diet-Based Nutritional Intervention on Gut Microbiota, Disease Activity, and Nutritional Status in Children With Systemic Lupus Erythematosus","Inclusion Criteria:\n\nFor participants with Systemic Lupus Erythematosus (SLE):\n\n* Diagnosis of SLE according to the SLICC classification criteria.\n* SLE diagnosis established at least 6 months prior to enrollment.\n\nFor healthy controls (household members):\n\n* Living in the same household as participants with SLE.\n* Body mass index (BMI) within the normal range.\n\nExclusion Criteria:\n\nFor participants with SLE:\n\n* Presence of active infection.\n* Renal failure, or history of major trauma or surgery within the past 6 months.\n* Presence of additional chronic diseases other than SLE.\n* Use of antibiotics or probiotics within the past 4 weeks.\n* Following a specific or restrictive diet.\n* Illiteracy or cognitive impairment that may limit understanding of the intervention.\n\nFor healthy controls (household members):\n\n* Presence of active infection\n* Presence of any chronic disease\n* Use of antibiotics or probiotics within the past 4 weeks\n* Following a specific or restrictive diet\n* Illiteracy or cognitive impairment that may limit understanding of study procedures","8 Years",{"count":418,"type":23},[126],"The goal of this clinical trial is to learn if a Mediterranean diet can improve gut microbiota, disease activity, and nutrition in children with systemic lupus erythematosus (SLE). The study will include children with SLE and healthy family members living in the same home.\n\nThe main questions it aims to answer are:\n\nDoes a Mediterranean diet improve gut microbiota in children with SLE? Does the diet help reduce disease activity? Does the diet improve overall nutrition? Researchers will compare children with SLE to healthy family members to better understand how diet, gut microbiota, and health are related.\n\nParticipants will:\n\nGive stool samples at the beginning and end of the study to analyze gut microbiota.\n\nHave body measurements taken. Record what they eat for 3 days (2 weekdays and 1 weekend day). Answer questions about their diet, physical activity, sleep, and health. Children with SLE in the intervention group will receive nutrition counseling based on the Mediterranean diet for 12 weeks. The counseling will focus on increasing foods rich in polyphenols and reducing processed foods to improve overall diet quality. They will also receive advice on physical activity.\n\nAt the end of the study, some participants will join a group discussion to share their experiences.",[29],[445,134,446,447,448],"Mediterranean Diet","Gut microbiota","Individual nutrition counseling","Child","2026-04-21",{"date":399,"type":50},{"date":452,"type":23},"2026-06",{"date":454,"type":23},"2029-02",{"name":456,"class":145},"TC Erciyes University",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":464,"targetDuration":4,"studyType":24,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":87},"100634787","phase-1-study-investigating-the-safety-of-anti-cd19-car-t-cells-therapy-produced-at-gustave-roussy-for-adults-with-severe-and-refractory-systemic-autoimmune-rheumatic-diseases-100634787","NCT07544225","Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases","CELL-ATTACK 1","Inclusion Criteria:\n\n* Adults aged 18-75 with ECOG PS 0-2 with written informed consent, valid health insurance, and eligibility for CAR T cell infusion are required may be included. Patients must have a treatment refractory systemic autoimmune rheumatic disease (RA, SLE, Sjögren's, SSc, or IIM) with severe, progressive activity with adequate renal function (creatinine clearance \\> 30 mL\u002Fmin)\n\nExclusion Criteria:\n\n* Patients with any significant active infection, including hepatitis B or C, HIV, or other opportunistic or recurrent infections, are excluded. Prior gene therapy, previous CAR T treatment, active cancer within 2 years, or any history of allogeneic stem cell or solid organ transplantation exclude participation. Inadequate organ function-renal, hepatic, cardiac (LVEF \\\u003C 50%), or lung function requiring oxygen- and uncontrolled comorbidities prevents inclusion. Pregnancy, breastfeeding, or refusal to use highly effective contraception for 12 months post infusion",{"count":465,"type":23},6,[71],"This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).",[286,29,469,347,346],"Sjogren's Disease With Dry Eyes","2026-04-15",{"date":327,"type":50},{"date":473,"type":23},"2026-09-01",{"date":475,"type":23},"2043-02-01",{"name":477,"class":145},"Gustave Roussy, Cancer Campus, Grand Paris",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":65,"sex":18,"minAge":231,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":24,"phases":489,"briefSummary":490,"conditions":491,"keywords":500,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":146},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701","NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment","59 Years",{"count":488,"type":23},477,[309],"The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[286,492,29,493,347,494,495,312,496,497,498,499],"Juvenile Idiopathic Arthritis (JIA)","Juvenile Systemic Lupus Erythematosus","Idiopathic Inflammatory Myopathies (IIMs)","Axial Spondyloarthritis","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[501,502,503,504,505,506,507],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","2026-04-14",{"date":470,"type":50},{"date":511,"type":23},"2026-03-16",{"date":513,"type":23},"2028-12-30",{"name":515,"class":145},"University of Sao Paulo General Hospital",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":523,"targetDuration":4,"studyType":24,"phases":525,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":4},"100634320","phase-1-a-clinica-study-of-sctc21c-in-participants-with-systemic-lupus-erythematosus-100634320","NCT07538154","A Clinica Study of SCTC21C in Participants With Systemic Lupus Erythematosus","A Phase Ib\u002FII Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTC21C in Participants With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Aged 18-75 years;\n2. Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR\u002FEULAR diagnostic criteria for SLE screening period;\n3. SELENA-SLEDAI ≥8 at screening;\n4. Positive immunological markers within 12 months prior to baseline;\n5. Currently receiving ≥1 stable doses of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs;\n6. All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 5 months after the last dose of the study drug\n7. Understanding of the study procedures and voluntary signing of the informed consent form\n\nExclusion Criteria:\n\n1. Severe active or unstable lupus-related neuropsychiatric disorders;\n2. Combined with active infections, malignant tumors, or other autoimmune diseases;\n3. Catastrophic antiphospholipid syndrome;\n4. severe lupus nephritis;\n5. Study participants who received a live or attenuated vaccine within 28 days prior to baseline or during the screening period;\n6. Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);\n7. Patients at high risk of severe clinical bleeding, or those requiring plasma transfusion, intravenous immunoglobulin, or acute blood products;;\n8. Patients who experienced any of the following cardiovascular or cerebrovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association (NYHA) Class II or higher heart failure, stroke, etc.;\n9. In accordance with the protocol requirements, participants with abnormal laboratory test results;\n10. Participants with positive results of viral serology, including Treponema pallidum, HIV, HCV, and HBV;\n11. participants with a history of tuberculosis or latent tuberculosis infection;\n12. Diagnosed with type 1 or type 2 diabetes with poor control;\n13. Uncontrolled hypertension;\n14. Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTC21C injection;\n15. Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;\n16. History of solid organ or hematopoietic stem cell\u002Fbone marrow transplant, or expected to undergo transplant surgery during the study;\n17. Pregnant or breastfeeding;\n18. Any other condition that the investigator deems unsuitable for participation in the study",{"count":524,"type":23},159,[71,72],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus",[29],[35],"2026-04-12",{"date":531,"type":50},"2026-04-20",{"date":533,"type":23},"2026-04",{"date":535,"type":23},"2028-04",{"name":537,"class":57},"Sinocelltech Ltd.",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":545,"enrollmentInfo":546,"targetDuration":548,"studyType":98,"phases":4,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":7},"100511031","lupus-landmark-study-a-prospective-registry-and-biorepository-100511031","NCT05934149","Lupus Landmark Study: A Prospective Registry and Biorepository","Lupus Nexus Landmark Study: A Prospective Registry and Biorepository","Inclusion Criteria:\n\n* Able to understand and comply with study procedures and voluntarily sign a written informed consent document\n* Age 18 years or older at the time of enrollment\n* Fulfill criteria for SLE based on one or more of the following classifications systems:\n\nSystemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 criteria; European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 criteria; 1997 revised ACR criteria; or Lupus is present per clinical assessment.\n\nExclusion Criteria:\n\n* Not able to obtain consent\n* Not able to meet protocol visit requirements\n* Pregnant at the time of enrollment","110 Years",{"count":547,"type":23},3500,"5 Years","The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).",[29,348,551],"Neuropsychiatric Systemic Lupus Erythematosus","2026-04-10",{"date":470,"type":50},{"date":555,"type":50},"2023-06-28",{"date":557,"type":23},"2035-12",{"name":559,"class":145},"Lupus Research Alliance",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":339,"enrollmentInfo":567,"targetDuration":4,"studyType":24,"phases":568,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":577,"locationsCount":87},"100627388","phase-2-to-evaluate-the-efficacy-and-safety-of-sg301-sc-injection-in-systemic-lupus-erythematosus-100627388","NCT07447986","To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus","A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SG301 SC Injection in Patients With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Voluntarily participate in the clinical study and sign a written informed consent form.\n2. Participants must be diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatism (ACR) SLE classification criteria and have inadequate response to standard treatment, intolerance to standard treatment, or recurrent disease.\n3. SLEDAI-2K score ≥ 8 points, with clinical features corresponding to a SLEDAI-2K score ≥ 4 points.\n4. Positive serological test results for autoantibodies, defined as antinuclear antibody (ANA) positivity and\u002For anti-double-stranded DNA (anti-dsDNA) antibody positivity.\n5. Body weight ≥ 35 kg.\n6. Must have received standard treatment for at least 8 weeks before the first dose and maintained a stable dose of the treatment unchanged for at least 4 weeks before the first dose.\n7. Participants of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive measures throughout the entire study period and within 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Previous use of CD38 or monoclonal antibodies targeting CD38.\n2. Active central nervous system (CNS) disease within 2 months before the first dose, or CNS disease that the investigator believes may require treatment with prohibited therapies specified in the protocol.\n3. Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis.\n4. Laboratory abnormalities.\n5. Current acute or chronic infection meeting any of the following criteria.\n6. Participation in any other clinical trial within 4 weeks before the first dose (excluding participants who provided informed consent but did not receive trial treatment, or only received placebo).\n7. Use of any targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before the first dose.\n8. Receipt of any B cell-depleting drugs (such as belimumab, telitacicept) within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.\n9. Receipt of JAK inhibitor treatment within 2 weeks before the first dose.\n10. Presence of severe cardiovascular and cerebrovascular diseases.\n11. Mycobacterium tuberculosis infection.\n12. Presence of HIV infection, active hepatitis B, or hepatitis C.\n13. Known history of active syphilis.\n14. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002For bone marrow transplantation.\n15. Other conditions that the investigator believes would prevent the participant from participating in the study.",{"count":380,"type":23},[72],"This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based on the Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response rate. The secondary objectives were to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants .",[29],"2026-04-01",{"date":573,"type":50},"2026-04-02",{"date":575,"type":50},"2026-03-26",{"date":110,"type":23},{"name":578,"class":57},"Hangzhou Sumgen Biotech Co., Ltd.",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":586,"targetDuration":4,"studyType":24,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":600},"100583410","phase-4-a-study-to-continue-the-administration-of-deucravacitinib-in-participants-with-systemic-lupus-erythematosus-sle-or-discoid-andor-subacute-cutaneous-lupus-erythematosus-dlescle-who-have-completed-study-im011074-or-study-im011132-100583410","NCT06875960","A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and\u002For Subacute Cutaneous Lupus Erythematosus (DLE\u002FSCLE) Who Have Completed Study IM011074 or Study IM011132","A Continuation Protocol for Deucravacitinib in Patients With Patients With Systemic Lupus Erythematosus (SLE) or Discoid and\u002For Subacute Cutaneous Lupus Erythematosus (DLE\u002FSCLE) Who Have Completed Study IM011074 or Study IM011132","Inclusion Criteria\n\n* Participants must have completed Study IM011074 or Study IM011132 through the protocol-required treatment period.\n* Participants must be, based on the physician's medical judgement, likely to receive benefit from receiving treatment with deucravacitinib.\n* Participants must have received IP within 60 days of enrollment. Exceptions may be granted based upon consultation with BMS.\n\nExclusion Criteria\n\n* Participants must not have any disease or medical condition that, in the opinion of the physician, would make the subject unsuitable for this protocol, would interfere with the interpretation of subject safety or considered unsuitable by the physician for any other reason.\n* Participants must not have any evidence of active Tuberculosis (TB).\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":587,"type":23},35,[309],"The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and\u002For Subacute Cutaneous Lupus Erythematosus (DLE\u002FSCLE) who have completed study IM011074 or Study IM011132",[29,591],"Discoid and\u002For Subacute Cutaneous Lupus Erythematosus (DLE\u002FSCLE)","2026-03-27",{"date":594,"type":50},"2026-03-30",{"date":596,"type":50},"2026-02-24",{"date":598,"type":23},"2026-12-01",{"name":273,"class":57},4,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":18,"minAge":548,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":24,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":87},"100630620","early-phase-1-exploratory-clinical-study-on-the-safety-and-efficacy-of-anti--cd19bcma-car-nk-cell-injection-for-the-treatment-of-refractory-pediatric-rheumatic-diseases-100630620","NCT07490041","Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19\u002FBCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases","Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19\u002FBCMA CAR-NK Cell Injection for the Treatment of Relapsed\u002FRefractory Pediatric Rheumatic Diseases","Cell therapy","Common Inclusion Criteria:\n\n1. . Gender unrestricted, age ≥5 years;\n2. . The patient or their legal guardian agrees to participate in this clinical trial and signs the informed consent form, indicating their understanding of the trial's purpose and procedures and willingness to participate;\n3. . Peripheral blood B cells confirmed by flow cytometry to express CD19, with a B cell count \\>5 cells\u002FuL;\n4. . If previously treated with B cell-targeted therapy, peripheral blood B cell count at screening has returned to normal or above the pre-treatment level;\n5. . Echocardiography indicates basically normal cardiac structure and left ventricular ejection fraction (LVEF) ≥55%; electrocardiogram shows no significant abnormalities;\n6. . Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN, total bilirubin (TBIL) ≤2.0×ULN;\n7. . Renal function: estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73m²; (If eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² and\u002For undergoing renal replacement therapy, the subject may be considered for enrollment after the investigator's assessment that the benefit outweighs the risk and with full informed consent from the patient\u002Fguardian);\n8. . Pulmonary function: No severe pulmonary lesions, blood oxygen saturation (SpO₂) ≥92%;\n9. . Female subjects of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the trial until 1 year after infusion.\n\nPolyarticular Juvenile Idiopathic Arthritis (pJIA):\n\n1. . Onset before age 16, disease duration ≥6 weeks, diagnosed as polyarticular JIA according to the 2001 International League of Associations for Rheumatology (ILAR) classification criteria, and positive for rheumatoid factor (RF) and\u002For anti-citrullinated peptide\u002Fprotein antibody (ACPA): positive on ≥2 occasions at least 3 months apart during the first 6 months of illness;\n2. . Judged by the investigator to have active disease despite adequate standard-dose treatment prior to screening, meeting the following adequacy of treatment conditions: a. Treatment with conventional disease-modifying antirheumatic drugs (DMARDs) for at least 6 months, with stable doses of 2 DMARDs for ≥12 weeks; b. Treatment with at least 2 biologic agents, with stable doses for ≥12 weeks;\n3. . Juvenile Arthritis Disease Activity Score-27 (JADAS-27) \\>8.5;\n4. . Must have at least 5 active joints (defined as the presence of joint swelling; or in the absence of swelling, the presence of limited range of motion accompanied by pain on motion and\u002For tenderness) as per the American College of Rheumatology (ACR) definition at both screening and baseline;\n5. . No occurrence of macrophage activation syndrome within 1 month prior to screening.\n\nSjögren's Syndrome (SS):\n\n1. . Diagnosed with childhood-onset primary SS at least 24 weeks prior to signing the ICF, according to the 2002 American-European Consensus Group (AECG) classification criteria \u002F 2016 EULAR\u002FACR classification criteria and the 2021 Japanese classification criteria for childhood primary SS;\n2. . Meet the classification criteria for SS, and Intolerance or inadequate response to glucocorticoids (prednisone 1-2 mg\u002Fkg\u002Fday or equivalent doses of other corticosteroids) and at least 2 immunosuppressants, with a duration of glucocorticoid treatment of at least 6 months;\n3. . EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5 in at least 1 of the following 8 domains at screening: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological, and serological;\n4. . EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score ≥5 at screening;\n5. . Positive for anti-SSA\u002FRo antibody.\n\n   Juvenile Dermatomyositis (JDM):\n6. . Diagnosed with JDM at least 24 weeks prior to signing the ICF according to the 2017 EULAR\u002FACR classification criteria;\n7. . Meet the classification criteria for Refractory JDM (RJDM), and had Intolerance or inadequate response to glucocorticoids (prednisone 1-2 mg\u002Fkg\u002Fday or equivalent doses of other corticosteroids) and at least 2 immunosuppressants, with a duration of glucocorticoid treatment of at least 6 months;\n8. . Patients with anti-synthetase syndrome who are anti-synthetase antibody positive and meet the criteria for RJDM can be directly enrolled;\n9. . Patients with immune-mediated necrotizing myopathy who are signal recognition particle (SRP) or 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody positive and meet the criteria for RJDM can be directly enrolled.\n\nSystemic Sclerosis (SSc):\n\n1. . Meet the 2013 ACR\u002FEULAR classification criteria for SSc, with first non-Raynaud's phenomenon occurring at age \\\u003C18 years and disease duration ≤60 months;\n2. . Positive for antinuclear antibody (ANA) or any SSc-specific antibody;\n3. . Modified Rodnan Skin Score (mRSS) ≥15 (total score 51);\n4. . Meet the definition of treatment-refractory disease: inadequate response to glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) and cyclophosphamide and at least 1 other immunomodulatory drug for over 3 months;\n5. . Diagnosed with refractory UCTD-ILD: UCTD typically refers to patients with symptoms and signs suggestive of CTD and serologic evidence of autoimmunity, but not fulfilling classification criteria for any defined CTD. Presence of ILD-related clinical manifestations: e.g., dry cough, exertional dyspnea, bibasral crackles, clubbing, OR chest high-resolution CT consistent with ILD features (often symmetric, subpleural), OR pulmonary function tests showing impaired diffusion capacity and restrictive ventilatory defect. All patients must have no improvement in symptoms like dyspnea or cough after at least 1 month of glucocorticoid therapy (prednisone ≥1 mg\u002Fkg\u002Fday or equivalent).\n\nSystemic Lupus Erythematosus (SLE):\n\n(1. Diagnosed with childhood-onset SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) or 2019 EULAR\u002FACR classification criteria for SLE; (2). Must meet one of the following adequacy of treatment conditions:\n\n* After treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent) and one or more immunomodulators (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, telitacicept, belimumab, and rituximab) for 3 months (3M);\n* Patients intolerant to conventional therapy may be considered for enrollment after the investigator judges benefit outweighs risk and with full informed consent from the patient\u002Fguardian;\n* OR inability to taper glucocorticoids to ≤5 mg\u002Fday after 6 months (6M) of conventional therapy; (3). Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score \\>6; (4). No occurrence of macrophage activation syndrome within 1 month prior to screening.\n\nMixed Connective Tissue Disease (MCTD):\n\n(5). Diagnosed with childhood-onset primary MCTD at least 24 weeks prior to signing the ICF according to the Sharp 1986 MCTD classification criteria adapted for children; (6). Meet the above childhood MCTD classification criteria, and also had Intolerance or inadequate response to glucocorticoids (prednisone 1-2 mg\u002Fkg\u002Fday or equivalent doses of other corticosteroids) and at least 2 conventional immunosuppressants, with a duration of standardized glucocorticoid treatment of at least 6 months; (7). Childhood version of the Mixed Connective Tissue Disease Activity Index (MDAI) score ≥8 at screening; (8). Patient-reported outcome (PRO) score for MCTD characteristic involvement dimensions ≥5 at screening; (9). High-titer positive for anti-U1-RNP antibody (titer ≥1:1000), and negative for anti-Sm antibody.\n\nExclusion Criteria:\n\n1. . History of malignancy (except for basal cell or squamous cell skin cancer or carcinoma in situof the cervix that has been excised and cured for at least 5 years), or current malignancy.\n2. . Known allergy, hypersensitivity, intolerance, or contraindication to CD19\u002FBCMA CAR-NK cells or any component of the drugs that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or subjects who have experienced a severe allergic reaction in the past.\n3. . Evidence of severe active viral or bacterial infection, or uncontrolled systemic fungal infection at screening or baseline visits, or subjects with active or uncontrolled infection requiring parenteral antimicrobial therapy.\n4. . Subjects with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) functional classification (see Appendix).\n5. . Subjects with congenital heart disease, or history of acute myocardial infarction within 6 months prior to screening, or severe arrhythmia (including multifrequent ventricular premature beats, supraventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs requiring vasopressors to maintain blood pressure.\n6. . Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA levels above the normal reference range in peripheral blood at screening; OR positive hepatitis C virus (HCV) antibody with detectable HCV RNA levels above the normal reference range; OR positive human immunodeficiency virus (HIV) antibody; OR positive syphilis test; OR positive cytomegalovirus (CMV) DNA test.\n7. . History of severe herpes infection, such as herpes encephalitis, ocular herpes, or disseminated herpes; signs of herpes or varicella-zoster virus infection (particularly varicella, herpes zoster) within 12 weeks prior to screening.\n8. . Current active tuberculosis or history of active tuberculosis, or subjects whose interferon-gamma release assay for tuberculosis infection cannot yield a negative result during the screening period.\n9. . Subjects with interstitial lung disease (ILD), meeting any of the following conditions are excluded: Forced vital capacity (FVC) \\\u003C50% of predicted value at screening, OR diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C40% of predicted value; Requiring long-term oxygen therapy or non-invasive ventilation; Acute exacerbation of interstitial pneumonia\u002Facute respiratory failure within the past 6 months, or hospitalization due to ILD requiring intravenous pulse corticosteroid therapy; Rapidly progressive ILD as judged by the investigator.\n10. . Subjects with pulmonary arterial hypertension (PAH), meeting any of the following conditions are excluded: Results from right heart catheterization or echocardiography (non-invasive estimation) meeting any of the following: a. Estimated systolic pulmonary artery pressure (sPAP) \\>50 mmHg (assessed in conjunction with tricuspid regurgitation velocity); b. Diagnosis of WHO functional class III or IV PAH.\n\n    Hospitalization within the past 6 months due to acute exacerbation of PAH or right heart failure; Requiring intravenous prostacyclin analog therapy during the screening period; Presence of signs of right ventricular dysfunction, including but not limited to ascites, hepatic congestion, peripheral edema, accompanied by significantly elevated BNP\u002FNT-proBNP levels and clinically unstable symptoms.\n11. . History of epilepsy or other active central nervous system diseases.\n12. . Subjects with acquired or congenital immunodeficiency diseases.\n13. . History of any clinically significant cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal disease, or other major condition that, in the investigator's judgment, precludes the administration of KN5601.\n14. . Solid organ or hematopoietic stem cell transplantation within 3 months prior to screening; OR acute graft-versus-host disease (GVHD) of grade 2 or higher within 2 weeks prior to screening.\n15. . Vaccination with a live vaccine within 4 weeks prior to screening.\n16. . Having received the following treatments within the specified time frames prior to the baseline visit: B cell depletion therapy within 26 weeks; Within 24 weeks prior to randomization: Anti-CD40 monoclonal antibody, belimumab, abatacept, anti-tumor necrosis factor alpha (anti-TNFα) biologics, immunoglobulin, plasmapheresis; Within 12 weeks prior to randomization: JAK inhibitors or other kinase inhibitors, unless explicitly permitted by the protocol; Use of traditional Chinese medicines, proprietary Chinese medicines, or health products containing Tripterygium wilfordii(Lei Gong Teng), Tripterygium hypoglaucum(Kunming Shan Hai Tang), Colquhounia coccineavar. mollis(Huo Ba Hua Gen), or white peony root (Paeonia lactiflora, Bai Shao) within 4 weeks; Within 3 half-lives of prior therapy, OR within 4 weeks, OR until the expected pharmacodynamic effects have returned to baseline levels (whichever is longer); B cell count below the lower limit of normal or baseline value (whichever is lower) following prior B cell depletion therapy.\n17. . Participation in any clinical trial within three months.\n18. . Any other condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the trial results.",{"count":610,"type":23},36,[189],"A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19\u002FBCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases.",[614,615,29,616],"Rheumatic Diseases","Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)","Connective Tissue Disease-associated Interstitial Lung Disease","2026-03-18",{"date":619,"type":50},"2026-03-24",{"date":621,"type":23},"2026-03-19",{"date":623,"type":23},"2027-12-19",{"name":625,"class":145},"The Children's Hospital of Zhejiang University School of Medicine",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":632,"maxAge":185,"enrollmentInfo":633,"targetDuration":4,"studyType":24,"phases":635,"briefSummary":636,"conditions":637,"keywords":638,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":87},"100619118","phase-2-the-efficacy-and-safety-of-biologics-belimumab-telitacicept-induction-therapy-in-proliferative-lupus-nephritis-patients-for-6-months-compared-with-mycophenolate-mofetil-treatment-100619118","NCT07340463","The Efficacy and Safety of Biologics (Belimumab\u002F Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment","Inclusion Criteria:\n\n* 1.Signed written informed consent form. 2.Age 14-65 years (inclusive), any gender. 3.Meets the American College of Rheumatology (ACR) SLE diagnostic criteria (1997).\n\n  4.All patients have biopsy-confirmed class III\u002FIV ± V LN within the past six months.\n\n  5.SLE-DAI score \\> 6. 6.Urine protein quantification \\> 1.0 g\u002Fd.\n\nExclusion Criteria:\n\n* 1.Estimated glomerular filtration rate (eGFR) ≥45 ml\u002Fmin\u002F1.73 m². 2.Patients who have received renal replacement therapy, plasma exchange, immunoadsorption, or high-dose intravenous immunoglobulin (100g) within the past 2 months.\n\n  3.Patients with concomitant critical organ damage or lupus crisis (e.g., pulmonary hemorrhage, encephalopathy, heart failure) deemed unsuitable for clinical trial participation by the investigator.\n\n  4.Hematological abnormalities: White blood cells \\\u003C3000\u002FμL, absolute neutrophil count \\\u003C1500\u002FμL, or lymphocytes \\\u003C800\u002FμL, platelet count \\\u003C50,000\u002FμL (unless due to SLE activity).\n\n  5.Liver function abnormalities: ALT, AST, or bilirubin levels exceeding 2 times the upper limit of normal.\n\n  6.Known allergy or contraindication to any component of belimumab and\u002For telitacicept.\n\n  7.Active infection or intravenous antibiotic use within 1 month prior to enrollment.\n\n  8.Pregnant or breastfeeding women. 9.Current or within the past 3 months: Active hepatitis B, hepatitis C, tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection, or HIV infection; active peptic ulcer; history of drug abuse or alcoholism; severe malnutrition (BMI \\\u003C16 kg\u002Fm²).\n\n  10.Other conditions: Severe cardiovascular disease potentially life-threatening; chronic obstructive pulmonary disease, or asthma\u002Fallergic diseases requiring long-term oral steroid treatment; malignant hypertension; history of malignancy within the past 5 years (except for completely treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia).\n\n  11.Other situations deemed unsuitable for enrollment by the investigator.","14 Years",{"count":634,"type":23},50,[72],"1. Study Design This is a single-center, prospective, randomized, controlled, exploratory clinical trial. The study is designed to evaluate and compare the efficacy and safety of two biologic-based induction regimens against standard of care (SOC) and a triple-combination regimen in patients with active proliferative lupus nephritis (LN).\n2. Study Objectives Primary Objective: To compare the 6-month complete renal response (CRR) rate among patients receiving biologic-based induction therapy, SOC induction therapy, and triple-combination induction therapy.\n\n   Secondary Objectives: To compare the rates of partial renal response (PRR) and overall renal response (ORR) at monthly intervals up to Month 6; to assess the time to achieve CRR\u002FPRR; to evaluate changes in clinical and immunological parameters from baseline; and to compare the safety profiles of the three treatment regimens.\n3. Key Eligibility Criteria Patients aged 14-65 years with biopsy-proven active Class III or IV (±V) LN according to ISN\u002FRPS 2018 classification, an SLE-DAI score \\>6, and 24-hour urine protein \\>1.0 g\u002Fd will be eligible. Key exclusion criteria include an eGFR ≥45 ml\u002Fmin\u002F1.73m², recent use of renal replacement therapy or potent immunosuppressive procedures, significant concurrent infections, severe hematological\u002F hepatic abnormalities, and known hypersensitivity to the study biologics.\n4. Treatment Groups and Intervention\n\n   Eligible patients will be randomized in a 2:2:1 ratio to one of three treatment arms for a 6-month induction period:\n\n   Biologics Group (n≈20): Glucocorticoids + either Belimumab or Telitacicept. SOC Group (n≈20): Glucocorticoids + Mycophenolate Mofetil (MMF). Triple Therapy Group (n≈10): Glucocorticoids + MMF + either Belimumab or Telitacicept.\n\n   The choice between Belimumab and Telitacicept within the Biologics and Triple Therapy groups will be determined jointly by the investigator and the patient.\n5. Study Medications \\& Administration Glucocorticoids: All patients will receive oral prednisone (or equivalent) starting at 0.5 mg\u002Fkg\u002Fday (max 40 mg\u002Fday), with a mandatory taper to ≤5 mg\u002Fday by Month 4 and stable dosing from Months 5-6. Intravenous methylprednisolone pulses are permitted per investigator discretion.\n\n   Mycophenolate Mofetil (MMF): Administered only in the SOC and Triple Therapy groups. The target dose is 1.5-2.0 g\u002Fday, maintained until the end of the treatment period.\n\n   Belimumab: Administered via intravenous infusion at 10 mg\u002Fkg (600 mg\u002Fdose) every 2 weeks.\n\n   Telitacicept: Administered via subcutaneous injection at 160 mg once weekly. Patients in the Biologics or SOC groups showing no response by Month 3 may directly switch to the Triple Therapy regimen.\n6. Primary Efficacy Endpoint\n\nThe primary endpoint is the proportion of patients achieving Complete Renal Response (CRR) at Month 6. CRR is strictly defined as:\n\n24-hour urine protein \\\u003C0.5 g\u002Fd, AND Estimated Glomerular Filtration Rate (eGFR) ≥85% of the baseline value, AND No requirement for rescue therapy or premature treatment withdrawal. 7. Secondary Efficacy \\& Safety Assessments Key secondary efficacy assessments include monthly CRR, PRR, and ORR rates; time to response; incidence of renal-related events; and changes in proteinuria, eGFR, serum creatinine, and disease activity scores (SELENA-SLEDAI, BILAG-2004, PGA). Safety will be evaluated through the incidence and severity of adverse events, with special attention to infections, infusion\u002Finjection reactions, and metabolic parameters.\n\n8\\. Statistical Considerations This is an exploratory study with a planned enrollment of 40-50 patients. The primary analysis will use the Full Analysis Set (FAS) under the intention-to-treat principle. The difference in the Month 6 CRR rate among the three groups will be analyzed using the Chi-square test. Time-to-event data will be analyzed using the Kaplan-Meier method with Log-rank test for comparisons.\n\n9\\. Hypothesis: This study protocol outlines a head-to-head comparison of novel biologic-based induction strategies against current SOC for active LN. It aims to generate critical preliminary data on whether glucocorticoids combined with a biologic (Belimumab or Telitacicept) alone can induce effective renal remission, potentially offering a targeted treatment option with a different safety profile compared to conventional immunosuppressive therapy. The results may inform the design of larger, confirmatory trials in LN management.",[29,241],[35,639,640,348,641],"LN","Belimumab","Telitacicept",{"date":643,"type":50},"2026-03-12",{"date":645,"type":50},"2025-12-08",{"date":647,"type":23},"2029-06",{"name":649,"class":145},"Nanjing University School of Medicine",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":657,"enrollmentInfo":658,"targetDuration":4,"studyType":24,"phases":660,"briefSummary":661,"conditions":662,"keywords":663,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":87},"100579329","phase-1-ct1190b-in-the-treatment-of-patients-with-moderate-to-severe-refractory-systemic-lupus-erythematosus-sle-or-refractoryprogressive-systemic-sclerosis-ssc-100579329","NCT06822881","CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory\u002FProgressive Systemic Sclerosis (SSc)","A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory\u002FProgressive Systemic Sclerosis (SSc)","Inclusion Criteria:\n\n1. Voluntary signing of the Informed Consent Form (ICF)\n2. Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.\n3. No systemic active infection within 2 weeks before screening.\n4. Contraceptive requirements for participants with child - bearing potential.\n5. Negative pregnancy test for women with child - bearing potential. Inclusion Criteria for SLE\n\n\u003C!-- -->\n\n1. Meet the EULAR\u002FACR 2019 SLE classification criteria with a disease history ≥ 6 months.\n2. Treatment and disease activity requirements:\n\n   o Before screening, the participant must have received treatment with glucocorticoids combined with immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and\u002For biological agents for ≥ 3 months, with a stable dose for ≥ 2 weeks, and the disease is still in an active state. Oral corticosteroid requirements at the time of screening:\n\n   o If treated with corticosteroids alone, prednisone (or equivalent drug) ≥ 7.5 mg\u002Fday.\n\n   o When used in combination with immunosuppressive agents and\u002For biological agents, there is no minimum daily dose requirement for corticosteroids.\n3. Positive antibody test at screening: Positive antinuclear antibody, and\u002For positive anti-ds-DNA antibody, and\u002For positive anti-Smith antibody.\n4. Disease activity score or organ damage: At the screening stage, the SLEDAI - 2K score is ≥ 7 points\n5. Active organ involvement at screening: isolated skin and mucous membrane involvement is not eligible for inclusion.\n6. Adequate organ function:\n\n   o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL\u002Fmin without the need for hydration assistance.\n\n   o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹\u002FL and hemoglobin (Hb) ≥ 60 g\u002FL. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.\n\n   o Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).\n\n   o Coagulation function: Defined as international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\n   o Lung function: Oxygen saturation (SpO₂) ≥ 92% (measured by pulse oximeter) in room air.\n   * Cardiac function: Defined as a left ventricular ejection fraction (LVEF) ≥ 40% as evaluated by echocardiogram (ECHO) within 8 weeks before screening.\n\nInclusion Criteria for SSc\n\n1. Meet the 2013 EULAR\u002FACR classification criteria for systemic sclerosis and the diffuse - type manifestation simultaneously.\n2. Combined with interstitial pneumonia caused by SSc.\n3. Meet the definition of refractory or progressive disease:\n\n   o Refractory disease definition: Ineffective after more than 6 months of conventional treatment, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (more than 1 mg\u002Fkg\u002Fd) or cyclophosphamide, and one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including Actemra, Rituxan, belimumab, tabitacicept, etc.\n   * Progressive disease definition (in the past 6 months):\n   * Skin progression: An increase in mRSS \\> 10%.\n   * Lung disease progression: A 10% decrease in FVC, or a 5% decrease in FVC accompanied by a 15% decrease in DLCO.\n4. Important organ function:\n\n   o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL\u002Fmin without the need for hydration assistance.\n\n   o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹\u002FL and hemoglobin (Hb) ≥ 90 g\u002FL. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.\n\n   o Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).\n\n   o Coagulation function: INR ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN.\n\n   o Cardiac function: Good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 40%.\n\nExclusion Criteria:\n\n1. Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.\n2. Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.\n3. Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.\n4. Use of corticosteroids ≥ 10 mg\u002Fday of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.\n5. Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.\n6. Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.\n7. Vaccination with live-attenuated vaccines, inactivated vaccines, or RNA vaccines within 1 month before screening.\n8. Diagnosis of cancer within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer treated by radical therapy, local prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.\n9. Undergoing major surgery within 4 weeks before signing the ICF, or planning to undergo major surgery during the study, and the investigator deems it will pose an unacceptable risk to the participant.\n10. Positive test for HIV, syphilis, active hepatitis B virus infection, or active hepatitis C virus infection at screening.\n11. History of central nervous system diseases before screening, including but not limited to cerebrovascular accident, encephalitis, epilepsy, convulsions\u002Fseizures, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive impairment, organic brain syndrome, or mental illness.\n12. History of any of the following cardiovascular diseases within 1 month before screening: Heart failure of class III or IV as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases of significant clinical significance.\n13. Participation in other clinical studies within 3 months before screening or still within five half-lives after the last dose of the drug.\n14. Current presence of any uncontrolled active infection, including but not limited to active tuberculosis, etc.\n15. History or evidence of suicidal thoughts within 6 months before signing the ICF, or any suicidal behavior within the previous 12 months, and the investigator deems there is a significant suicide risk.\n16. Pregnant or breastfeeding women.\n17. Poor compliance judged by the investigator, inability or unwillingness to comply with the requirements of the study protocol, or other reasons that make the participant unsuitable for this clinical study.\n\nExclusion Criteria for SLE\n\n1. Severe lupus nephritis within 2 months before screening, requiring hemodialysis, or receiving prednisone ≥ 100 mg\u002Fd or equivalent corticosteroid treatment for ≥ 14 days.\n2. Lupus crisis within 1 month before screening, and the investigator deems it inappropriate for the participant to participate in this study.\n3. Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, seizures, cognitive impairment, impaired intellectual function, visual impairment, etc.\n4. History of ≥ grade 2 bleeding within 30 days before screening.\n5. Plasmapheresis, plasma separation, or hemodialysis within 14 days before screening.\n\nExclusion Criteria for SSc\n\n1\\. FVC ≤ 30% of the predicted value or DLCO (corrected for hemoglobin) ≤ 30% of the predicted value.\n\n2\\. Combined with severe kidney disease or signs of renal crisis in the participant.\n\n3\\. Risk of active tuberculosis at screening.","60 Years",{"count":659,"type":23},27,[71],"A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory\u002Fprogressive systemic sclerosis (SSc)",[29,347],[664],"CT1190B","2026-03-06",{"date":52,"type":50},{"date":668,"type":50},"2025-02-20",{"date":670,"type":23},"2026-12-31",{"name":672,"class":145},"Beijing GoBroad Hospital",{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":4,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":18,"minAge":680,"maxAge":185,"enrollmentInfo":681,"targetDuration":4,"studyType":24,"phases":683,"briefSummary":684,"conditions":685,"keywords":686,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":688,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":692,"locationsCount":87},"100561081","phase-1-anti-cd19-chimeric-antigen-receptor-t-cells-for-refractory-systemic-lupus-erythematosus-100561081","NCT06585514","Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus","Open-Label, Non-Randomized, Single-Arm, Phase 1\u002F2 Study of Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Male or female, aged 3-65 years.\n2. Have a diagnosis of SLE and meet the classification criteria of 2019 European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).\n3. Positive antinuclear antibody (ANA): ANA at a titer of ≥ 1:80 on Hep-2 cells or equivalent positive test (ever) and\u002For a positive anti-dsDNA serum antibody test (based on ELISA assay, ≥ 30 IU\u002FmL).\n4. Refractory SLE and\u002For refractory lupus nephritis (LN):\n\n   • 4.1 Refractory SLE 4.1.1 Patients received at least 7.5 mg\u002Fkg\u002Fday of prednisolone to maintain low disease activity or the SLEDAI 2K score ≥8.\n\n   4.1.2 Routine treatment is ineffective or the disease relapses after remission. Definition of routine treatment: use glucocorticoid (more than 1mg\u002Fkg\u002Fd) and cyclophosphamide for 6 months; and any of the following immunomodulatory drugs for more than 3 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents such as rituximab, belizumab, or telitacicept;\n\n   • 4.2 Refractory LN 4.2.1 Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR), Biopsy-proven LN class III, IVa \\[excluding III (C), IV-S (C) and IV-G (C)\\] or, class V lupus nephritis combined with class III or IV, according to 2018 Revised International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, see Appendix 3. Biopsy must be performed within 6 months before or during screening.\n\n   4.2.2 Refractory lupus nephritis is defined as no induced remission to treatment regimens containing at least one immunosuppressant (including glucocorticoids, CTX, tacrolimus, MME, and cyclosporine) after 3 to 6 months, accompanied by no reduction (or worsening) of proteinuria or persistent antibody positives.\n5. CD19+ on B cells and continuous withdrawal of the immunosuppressive drugs for more than 1 week.\n6. The blood routine lymphocyte count of the subjects is \\> 1 × 109\u002FL, and there is no cell collection contraindication.\n7. No severe allergy.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.\n9. Patients are expected to live for at least 90 days.\n10. Subjects and\u002For their guardian must understand and sign the informed consent.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Impaired consciousness or intracranial hypertension:\n\n   * Intracranial pressure elevation was above 15 mmHg;\n   * Organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, and other brain lesions requiring intervention.\n2. Symptomatic congestive heart failure or severe cardiac arrhythmia:\n\n   * Previously documented left ventricular ejection fraction (LVEF) by echocardiography of \\<45% in the 12 months;\n   * Abnormal electrocardiogram (ECG): left bundle branch block, bifascicular block or any clinically meaningful ECG abnormality;\n   * Congenital long QT syndrome or prolongation of the QT interval corrected for heart rate (QTcF) ≥ 470 ms. QTcF is calculated using Fridericia's Formula;\n   * Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification;\n   * Unstable or poorly controlled angina pectoris, including the prinzmetal variant of angina pectoris;\n   * Myocardial infarction within 6 months.\n3. Manifestations of severe respiratory system failure:\n\n   * Hypoxemic respiratory failure: PaO2 \\< 60 mmHg, PaCO2 \\< 50 mmHg at sea level, resting and breathing air conditions;\n   * Subjects with pulmonary hypertension (PH): mean pulmonary artery pressure (mPAP) ≥25 mmHg measured by right heart catheterization (RHC);\n   * Subjects with hypercapnia (PaCO2 ≥ 50mmHg ) and\u002For ventilatory dysfunction (PH \\<7.25 );\n   * Oxygen inhalation was required to maintain oxygen saturation;\n   * Acute or chronic respiratory diseases unrelated to SLE, such as acute pneumonia and interstitial lung disease.\n4. Co-existence with other malignancies.\n5. Disseminated intravascular coagulation (DIC).\n6. Sepsis or other uncontrollable infections: active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection) or other clinically significant active disease process.\n7. Uncontrollable diabetes: after at least 3 months of diet and exercise or similar treatment, fasting blood glucose (FBG) ≥ 8.0 mmol\u002FL, postprandial blood glucose (PBG) ≥ 15 mmol\u002FL, and glycosylated hemoglobin (HbA1c)≥8.0%; diabetic ketoacidosis or other uncontrollable complications of diabetes.\n8. Serious mental illness: alcohol or drug abuse, dementia, or any other condition that would impair the subject's ability to receive the planned treatment or to understand informed consent at the study site.\n9. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI).\n10. Underwent organ transplantation, excepting SCT.\n11. Pregnant females or lactation.\n12. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis.\n13. No peripheral blood mononuclear cells (PBMC) collection or frozen PBMC for CAR T cell manufacturing.\n14. eGFR CKD-EPI \\< 30 ml\u002Fmin\u002F1.73m2.\n15. Patients who are unable to discontinue immunosuppression agents for ≥7 days or whose condition recurs during discontinuation while the risk of serious adverse reactions is assessed by the investigator.\n16. Any active skin disease that may interfere with the evaluation of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE skin manifestations (e.g., cutaneous vasculopathies, peripapillary dilatation, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers), or drug-induced lupus.","3 Years",{"count":682,"type":23},18,[71,72],"The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).",[29,241],[29,241,687],"CD19 CAR-T",{"date":52,"type":50},{"date":690,"type":50},"2024-10-17",{"date":670,"type":23},{"name":672,"class":145}]