[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"childhood-onset-systemic-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:childhood-onset-systemic-lupus-erythematosus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100648292","phase-4-childhood-onset-lupus-nephritis-initial-glucocorticoid-dose-harmonization-trial-light-trial-100648292",false,"NCT07719140","Childhood-onset Lupus Nephritis Initial Glucocorticoid-dose Harmonization Trial (LIGHT Trial)","Low- Versus High-Dose Initial Glucocorticoid Therapy for Childhood-Onset Proliferative Lupus Nephritis: a Multicenter Open-Label Noninferiority Randomized Controlled Trial","LIGHT","Inclusion Criteria:\n\n* Age ≥6 years and \\\u003C18 years, with body weight ≥20 kg\n* Meets the 2019 European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)\n* Renal biopsy confirming Lupus Nephritis class III, IV, III+V, or IV+V according to the International Society of Nephrology \u002F Renal Pathology Society (ISN\u002FRPS) classification\n* At screening: 24-hour urinary protein ≥1.0 g (or ≥25 mg\u002Fkg), or urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg\n* White blood cell count ≥3.0 × 10⁹\u002FL and lymphocyte count ≥1.0 × 10⁹\u002FL\n* No prior intravenous methylprednisolone pulse therapy before enrollment, and glucocorticoid exposure ≤2 weeks before enrollment, with a maximum prednisone-equivalent dose ≤30 mg\u002Fday (or ≤1 mg\u002Fkg\u002Fday)\n* Written informed consent obtained and good treatment compliance expected\n\nExclusion Criteria:\n\n* Uncertain diagnosis of SLE, genetically confirmed monogenic lupus, or a history of immunodeficiency\n* Severe infection, including hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, etc.\n* Severe neuropsychiatric lupus\n* Peripheral blood hemoglobin \\\u003C60 g\u002FL, platelet count \\\u003C10 × 10⁹\u002FL, or concomitant aplastic anemia\n* Severe cardiac insufficiency (NYHA functional class ≥ II)\n* Severe pulmonary involvement, including pulmonary hemorrhage, respiratory failure, pulmonary embolism, or other conditions requiring respiratory support\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m²\n* Severe gastrointestinal bleeding, pancreatitis, or hepatic lesions\n* Patients deemed by the investigator to be unsuitable for participation in this trial","ALL","6 Years","18 Years",{"count":21,"type":22},198,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Childhood-onset systemic lupus erythematosus (cSLE) is a severe chronic autoimmune disease with a high burden of major-organ involvement. Lupus nephritis (LN) affects more than half of children with SLE, and proliferative LN-including class III, IV, III+V, and IV+V disease-is associated with acute kidney injury, progression to end-stage kidney disease, and poor long-term outcomes.\n\nGlucocorticoids remain a cornerstone of induction therapy for proliferative LN. However, the optimal initial dose in children is uncertain. Although recent adult SLE and LN guidelines increasingly recommend lower-dose glucocorticoid regimens with rapid tapering, pediatric guidelines still commonly recommend high initial prednisone doses of 1.5-2.0 mg\u002Fkg\u002Fday. Adult trials and comparative observational studies suggest that lower-dose glucocorticoid regimens may preserve efficacy while reducing treatment-related toxicity.\n\nBecause cumulative glucocorticoid exposure in children may impair growth, development, psychosocial well-being, and medication adherence, this trial will compare low-dose versus high-dose initial glucocorticoid regimens for induction treatment of pediatric proliferative LN. The objective is to determine whether a lower-dose regimen is non-inferior in efficacy while reducing glucocorticoid-related adverse effects and improving quality of life.",[28,29],"Childhood-onset Systemic Lupus Erythematosus","Lupus Nephritis (LN)",[31,32,33,34,35],"Children","Systemic lupus erythematosus","Lupus nephritis","Glucocorticoid","Therapy","RECRUITING","2026-07-17",{"date":39,"type":40},"2026-07-22","ACTUAL",{"date":42,"type":22},"2026-07",{"date":44,"type":22},"2029-03",{"name":46,"class":47},"Peking Union Medical College Hospital","OTHER",8,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100620031","immune-profiling-of-refractory-csle-exposed-to-cd3cd19-bite-100620031","NCT07352332","Immune Profiling of Refractory cSLE Exposed to CD3×CD19 BiTE","A Prospective Observational Study of Immune Profiling in Childhood-Onset Systemic Lupus Erythematosus Under CD3×CD19 Bispecific T-Cell Engager Exposure","BiTE-cSLE-IP","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Age ≥ 5 years.\n  2. Diagnosis of systemic lupus erythematosus (SLE) confirmed according to the 2019 EULAR\u002FACR classification criteria.\n  3. Refractory or persistently active SLE, defined by clinical evaluation and meeting at least one of the following conditions:\n\n  \u003C!-- -->\n\n  1. Inadequate response to prior standard treatments, including oral glucocorticoids, antimalarial agents, conventional immunosuppressants (cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide), and biologic therapies (telitacicept, belimumab, rituximab).\n  2. Moderate to high disease activity, such as a SLEDAI score ≥ 6. 4.Receiving CD3×CD19 bispecific T-cell engager (BiTE) therapy as part of routine clinical management, with traceable dosing information and treatment timeline.\n\n  5.Availability of peripheral blood samples collected before and\u002For after CD3×CD19 BiTE exposure, obtained during routine clinical assessment or prospective follow-up, that are suitable for immunologic analyses.\n\n  6.Prior informed consent obtained in a related clinical study or clinical care context that explicitly permits the storage and secondary use of biological samples and associated clinical data for disease-related scientific research, including prospective analyses during subsequent follow-up; and willingness of the child to cooperate with study follow-up procedures, as appropriate.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Inability to obtain peripheral blood samples of adequate quality for immunologic analyses, including insufficient sample volume, severe hemolysis, or failure to meet predefined cell viability criteria.\n2. Presence of acute severe infection, acute organ decompensation, or other acute medical conditions that may substantially interfere with immune profiling analyses.\n3. Significant risk associated with blood sampling, such as severe anemia, serious coagulation disorders, or other conditions deemed by the investigator to pose unacceptable risk for phlebotomy.\n4. Inability to obtain essential clinical data required for immune-clinical correlation analyses (e.g., disease activity scores, complement levels, autoantibody results, or renal parameters).\n5. Refusal of the legal guardian to allow participation or withdrawal of permission for use of biological samples, or lack of assent from the child when applicable.\n6. Any other condition that, in the opinion of the investigator, may compromise study completion, data integrity, or participant safety.","5 Years",{"count":59,"type":22},6,"OBSERVATIONAL","This prospective observational study aims to characterize the peripheral immune landscape of pediatric patients with childhood-onset systemic lupus erythematosus ( cSLE) who are receiving CD3×CD19 bispecific T-cell engager (BiTE) therapy under a separate, approved exploratory clinical study. The present study does not assign, modify, or influence any therapeutic interventions.\n\nPeripheral blood samples are collected longitudinally at predefined time points in parallel with routine clinical follow-up. Immune profiling is performed using multiparameter flow cytometry, with single-cell sequencing conducted in a subset of samples to further explore cellular and molecular features. Clinical data, including disease activity indices and relevant serological biomarkers, are recorded concurrently.\n\nThe objective of this study is to describe immune cell dynamics and immune features associated with changes in disease activity in cSLE, and to explore potential biomarker candidates that may inform future immune-monitoring strategies and mechanistic research in this population.",[28],[28,64,65,66,67,68],"Refractory Systemic Lupus Erythematosus","Immune Profiling","Bispecific T-Cell Engager","Single-Cell Sequencing","Flow Cytometry","2026-01-12",{"date":71,"type":40},"2026-01-20",{"date":73,"type":40},"2025-09-30",{"date":75,"type":22},"2027-12-30",{"name":77,"class":47},"The Children's Hospital of Zhejiang University School of Medicine",1]