[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lupus-nephritis-ln\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lupus-nephritis-ln":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,47,78,109,139,164,186,212,234,259,281,298,325,352,374,394,422,448,466,489,514,539,560,583,607],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100591081","phase-1-dose-escalation-study-with-bispecific-antibodies-in-adult-participants-with-lupus-nephritis-100591081",false,"NCT06975787","Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis","A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis","Key General Inclusion Criteria:\n\n1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol\n2. Participant must have refractory or relapsed disease, as described in the protocol\n\nKey General Exclusion Criteria:\n\n1. History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization\n2. Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening\n3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply","ALL","18 Years","60 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN).\n\nThe main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up.\n\nThis is a main study, called an umbrella study, which includes several independent smaller sub-studies. Each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating LN.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",[28],"Lupus Nephritis (LN)",[30,31,32,33],"Bispecific Antibodies (bsAb)","Double-stranded DNA (dsDNA)","LN class III or IV","Systemic Lupus Erythematosus (SLE)","RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":38},"2025-12-22",{"date":42,"type":22},"2029-09-09",{"name":44,"class":45},"Regeneron Pharmaceuticals","INDUSTRY",17,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"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":57,"type":22},24,[25,59],"PHASE2","This is a single-center, single-arm, open-label phase 1\u002F2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE).\n\nPhase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.",[62,33,63,64,65,66,28],"SLE","CAR T Cell","CART19","Cell Therapy","Lupus","2026-06-11",{"date":69,"type":38},"2026-06-15",{"date":71,"type":38},"2025-05-06",{"date":73,"type":22},"2030-02-28",{"name":75,"class":76},"Children's Hospital of Philadelphia","OTHER",1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100617815","phase-4-dapagliflozin-in-active-lupus-nephritis-100617815","NCT07323524","Dapagliflozin in Active Lupus Nephritis","Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis","Dapa-Active LN","Inclusion Criteria:\n\n* • Age 18-70 years, fulfilling 2012 SLICC or 2019 ACR\u002FEULAR criteria for SLE, with biopsy-proven class III, IV and\u002For V LN\n\n  * Active (new or relapsing) LN within the prior six months, with at least one of the following:\n\n    * Kidney biopsy with activity index \\>2 and\u002For\n    * Active urinary sediment (\\>5 RBCs, \\>5 WBCs, or cellular casts)\n  * Receiving standard-of-care immunosuppression regimen for active LN, including mycophenolate, cyclophosphamide, belimumab, azathioprine, a calcineurin inhibitor, and\u002For B cell depleting therapies\n  * Recent or ongoing glucocorticoids use for active LN within the past 6 months\n  * Receiving standard-of-care antimalarial therapy and RAAS blockade, unless contraindicated\n  * Estimated ≥0.5 g\u002Fg 24 hr proteinuria or ≥0.3 mg\u002Fg 24 hr microalbuminuria at enrollment (on first morning urine)\n  * Ability to given informed consent\n\nExclusion Criteria:\n\n* GFR \\\u003C 25 ml\u002Fmin\u002F1.73m2\n\n  * Acute kidney injury at study enrollment (\\>50 percent rise in creatinine within 90 days)\n  * Type I diabetes, underweight (BMI \\\u003C18.5), active malignancy, active infection, or recurrent genitourinary infections\n  * For females: pregnancy, or desiring of pregnancy and not using contraception, or unable to use contraception\n  * Current use of \\>1mg\u002Fkg\u002Fday prednisone equivalent\n  * Current or prior use of SGLT2 inhibitors or GLP-1 receptor agonists","70 Years",{"count":88,"type":22},33,[90],"PHASE4","Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease. This pilot and feasibility randomized clinical trial will test the use of dapagliflozin versus placebo in addition to standard of care treatment for patients with early and active lupus nephritis, a group who has not been included in past trials.",[28],[94,95,96,97,98],"dapagliflozin","SGLT2 inhibitor","safety","feasibility","pilot trial","2026-05-21",{"date":101,"type":38},"2026-05-26",{"date":103,"type":38},"2026-05-19",{"date":105,"type":22},"2030-01",{"name":107,"class":76},"Brigham and Women's Hospital",2,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":77},"100637500","a-study-to-evaluate-mtm-h-001-injection-in-adult-patients-with-b-cell-related-autoimmune-diseases-100637500","NCT07593911","A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases","An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)","ArchAid-002","Inclusion Criteria:\n\n* Key inclusion criteria include：\n\n  1. Male or female, aged 18 - 75 years old (inclusive);\n  2. The participant or his\u002Fher legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;\n  3. Confirmed diagnosis of the target autoimmune disease per international classification criteria;\n  4. Adequate organ function to tolerate treatment;\n  5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.\n\nExclusion Criteria:\n\n* Key exclusion criteria include:\n\n  1. Active, severe, uncontrolled infection;\n  2. Pregnancy or breastfeeding women;\n  3. History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;\n  4. Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.","75 Years",{"count":119,"type":22},75,[121],"NA","This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.",[124,28,125,126,127,128],"Systemic Lupus Erthematosus (SLE)","Multiple Sclerosis","Myasthenia Gravis (MG)","IgG4-Related Diseases","Rheumatoid Arthritis (RA)","NOT_YET_RECRUITING","2026-05-12",{"date":132,"type":38},"2026-05-18",{"date":134,"type":22},"2026-06",{"date":136,"type":22},"2031-06",{"name":138,"class":76},"Beijing GoBroad Hospital",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":77},"100634088","early-phase-1-efficacy-and-safety-of-cd19-car--t-cells-in-the-treatment-of-relapsedrefractory-autoimmune-nephropathy-100634088","NCT07535138","Efficacy and Safety of CD19 CAR-γδ T Cells in the Treatment of Relapsed\u002FRefractory Autoimmune Nephropathy","A Clinical Study on the Safety and Efficacy of CD19-Targeted Universal CAR-γδ T Cells in Relapsed\u002FRefractory Autoimmune Nephropathy","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n\n  1. Age ≥18 years and ≤65 years;\n  2. Agree to participate in this study and sign the informed consent form;\n  3. Major organ function must meet the following criteria (exceptions are allowed for abnormalities associated with active autoimmune diseases):\n\n     1. Liver function: ALT, AST or ALP level ≤3 × ULN (upper limit of normal), bilirubin ≤2 × ULN;\n     2. Renal function: eGFR ≥30 mL\u002Fmin\u002F1.73m²;\n     3. Pulmonary function: blood oxygen saturation (without oxygen inhalation) ≥92%;\n     4. Cardiac function: hemodynamically stable, left ventricular ejection fraction (LVEF) ≥55%;\n     5. Peripheral blood function: neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60 g\u002FL, platelets ≥30×10\\^9\u002FL;\n  4. Subjects of childbearing potential (including males and females) must agree to use medically acceptable effective contraceptive measures during the study period and for at least 1 year after CAR-T cell infusion.\n* Primary Membranous Nephropathy:\n\n  1. Diagnosed with primary membranous nephropathy (PMN) by renal biopsy within 18 months before screening;\n  2. Meet the current clinical criteria for refractory PMN: after 6 months of systemic treatment with immunosuppressive regimens recommended by the KDIGO guidelines (including steroids, cyclophosphamide, calcineurin inhibitors, anti-CD20 monoclonal antibodies, etc.), persistent 24-hour urinary protein ≥3.5g and not reduced to less than 50% of the baseline level;\n  3. Relapsed PMN: after achieving complete or partial remission with the above immunosuppressive regimens, 24-hour urinary protein re-elevated to ≥ 3.5g.\n* Lupus Nephritis:\n\n  1. Diagnosed with systemic lupus erythematosus (SLE) before screening, in accordance with the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus;\n  2. Diagnosed with lupus nephritis (LN) by renal biopsy within 18 months before screening, with pathological classification consistent with ISN\u002FRPS lupus nephritis class III\u002FIV (with or without class V);\n  3. SLEDAI-2000 score ≥6 at screening with at least 1 A grade or at least 2 B grades in the BILAG 2004 index; or SLEDAI-2000 score ≥8 at screening;\n  4. Meet the current clinical criteria for refractory LN: after standardized full-dose and full-course high-dose glucocorticoid plus hydroxychloroquine therapy combined with at least 2 immunosuppressive agents of different mechanisms (cyclophosphamide, mycophenolate mofetil, calcineurin inhibitors, etc.), or 1 immunosuppressive agent plus 1 biologic agent (belimumab, anti-CD20 monoclonal antibody, telitacicept, etc.), meet either of the following: ① After 3 months of standardized treatment, 24-hour urinary protein ≥1.5g and not reduced to less than 50% of baseline; ② After 6 months of standardized treatment, prednisone (or equivalent) cannot be tapered to 5 mg\u002Fday;\n  5. Relapsed LN: after achieving complete or partial remission with induction remission therapy, disease activity re-increased during maintenance therapy, requiring re-adjustment of the treatment regimen (including increasing glucocorticoid dose or re-initiating induction remission therapy).\n* IgA Nephropathy:\n\n  1. Diagnosed with IgA nephropathy by renal biopsy within 18 months before screening;\n  2. Meet the current clinical criteria for refractory IgA nephropathy: on the basis of standardized ACEI\u002FARB treatment, after 6 months of systemic immunosuppressive therapy recommended by the KDIGO guidelines (steroids, immunosuppressants, biologics), 24-hour urinary protein ≥0.5g and not reduced to less than 50% of baseline, or eGFR decreased by more than 50% within 3 months;\n  3. Two consecutive 24-hour urinary protein measurements \\> 0.5g with an interval of ≥ 2 weeks after achieving clinical remission with the above immunosuppressive therapy.\n\nExclusion Criteria:\n\n1. Subjects with life-threatening conditions (e.g., catastrophic antiphospholipid syndrome, acute severe renal failure) assessed by the investigator as unsuitable for enrollment in this study;\n2. History of alcohol or drug abuse within 24 weeks prior to screening;\n3. History of malignant tumors other than B-cell lymphoma, except for the following: malignancies confirmed to be cured or in remission for ≥5 years, radically resected basal cell carcinoma or squamous cell carcinoma of the skin, and carcinoma in situ at any site;\n4. Major surgery (including joint surgery) within 24 weeks prior to screening, or planned surgery within 24 weeks after enrollment;\n5. Complicated with overlapping mixed connective tissue disease, or other diseases that affect the assessment of disease activity;\n6. Active hepatitis B or hepatitis C virus infection, defined as: subjects positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with peripheral blood high-sensitivity HBV DNA quantification above the lower limit of detection; subjects with peripheral blood high-sensitivity HBV DNA quantification below the lower limit of detection may be enrolled only if the investigator provides appropriate prophylactic antiviral therapy; individuals positive for hepatitis C virus (HCV) antibody with positive peripheral blood high-sensitivity HCV RNA quantification;\n7. Coinfection with human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV), Treponema pallidum, cytomegalovirus (CMV), or complicated with selective IgA deficiency;\n8. Uncontrolled active infection (e.g., active pulmonary tuberculosis, etc., excluding simple urinary tract infection and bacterial pharyngitis); prophylactic administration of antibiotics, antiviral or antifungal agents is permitted;\n9. Clinical signs of herpes or varicella-zoster virus infection (especially varicella, herpes zoster) within 12 weeks prior to screening;\n10. History of major cardiovascular diseases within 6 months prior to screening, including NYHA class III or IV heart failure, myocardial infarction, angioplasty or stenting, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac diseases;\n11. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n12. Central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis);\n13. Pregnant or lactating women;\n14. Hypersensitivity to any component of the CAR-γδ T cell product (including fludarabine, cyclophosphamide, tocilizumab);\n15. Administration of live vaccines within 6 weeks prior to the start of conditioning therapy;\n16. Participation in other clinical trials within 3 months prior to screening;\n17. Any other conditions deemed by the investigator to render the subject ineligible for enrollment in this clinical trial.","65 Years",{"count":148,"type":22},15,[150],"EARLY_PHASE1","This study is a single-arm, single-center, open-label, dose-escalation exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of CD19 CAR-γδ T cells. The subjects enrolled in this study are patients with relapsed\u002Frefractory autoimmune nephropathy, including lupus nephritis, IgA nephropathy, and membranous nephropathy. This study adopts a standard \"3+3\" design to assess the recommended dose (RD) and identify dose-limiting toxicities (DLTs). The treatment process is as follows: subjects who meet the inclusion criteria will receive lymphodepletion conditioning, followed by a single intravenous infusion of CD19 CAR-γδ T cells. The primary objective of this study is to evaluate the safety profile of this cellular therapy, including the incidence of DLTs, maximum tolerated dose (MTD) or RD, as well as the incidence and severity of treatment-related adverse events and clinically significant abnormal laboratory test results after CAR-γδ T cell infusion (including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). The planned follow-up duration of this study is 1 years.",[153,28,154],"Membranous Nephropathy","IgA Nephropathy (IgAN)","2026-04-09",{"date":157,"type":38},"2026-04-16",{"date":159,"type":22},"2026-05-01",{"date":161,"type":22},"2028-12-30",{"name":163,"class":76},"Air Force Military Medical University, China",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":77},"100630763","phase-1-a-phase-1-study-of-hb2198-in-participants-with-moderately-to-severely-active-systemic-lupus-erythematosus-sle-100630763","NCT07491900","A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)","A Phase 1, Open Label Dose Escalating Study of HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody With Dual Fc Domains, in Patients With Moderately to Severely Active Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* • Meet 2019 ACR \u002F 2023 EULAR SLE classification criteria\n\n  * Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)\n  * LN participants: biopsy confirmed active Class III\u002FIV ± V or Class V LN; proteinuria ≥0.8 g\u002Fg; eGFR ≥30 mL\u002Fmin\u002F1.73 m²\n  * ERL participants: inadequate response\u002Fintolerance to ≥1 standard SLE therapy\n  * Positive ANA (≥1:80) or SLE associated autoantibodies\n  * Required minimum lab values (lymphocytes ≥500\u002FµL, B cells ≥25\u002FµL, ANC ≥1000\u002Fmm³, IgG ≥600 mg\u002FdL, etc.)\n  * Women of childbearing potential: negative pregnancy test; contraception required\n  * Voluntary informed consent\n\nExclusion Criteria:\n\n* (Key) Inclusion Criteria:\n\n  * Meet 2019 ACR \u002F 2023 EULAR SLE classification criteria\n  * Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)\n  * LN participants: biopsy confirmed active Class III\u002FIV ± V or Class V LN; proteinuria ≥0.8 g\u002Fg; eGFR ≥30 mL\u002Fmin\u002F1.73 m²\n  * ERL participants: inadequate response\u002Fintolerance to ≥1 standard SLE therapy\n  * Positive ANA (≥1:80) or SLE associated autoantibodies\n  * Required minimum lab values (lymphocytes ≥500\u002FµL, B cells ≥25\u002FµL, ANC ≥1000\u002Fmm³, IgG ≥600 mg\u002FdL, etc.)\n  * Women of childbearing potential: negative pregnancy test; contraception required\n  * Voluntary informed consent\n\n(Key) Exclusion Criteria:\n\n* Anti CD19 or anti CD20 therapy within 6 months\n* Active CNS lupus\n* Significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease\n* Active infection or recent serious infection\n* Positive HBV DNA or HCV RNA; HIV infection\n* Major surgery within 4 weeks\n* Prior organ or stem cell transplant\n* Current pregnancy or breastfeeding\n* Recent IVIg or plasmapheresis (\\\u003C3 months)\n* Live vaccine within 30 days\n* Any condition judged unsuitable by Investigator",{"count":172,"type":22},30,[25],"This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19\u002FCD20 antibody, in adults with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and extra renal lupus. Approximately 30 participants will receive two intravenous doses of HB2198 and be followed for 12 months to assess safety, B cell depletion, disease activity, immunologic biomarkers, and renal outcomes.",[124,28,176],"Extra-renal Lupus (ERL)","2026-03-18",{"date":179,"type":38},"2026-03-25",{"date":181,"type":22},"2026-03-23",{"date":183,"type":22},"2028-10-24",{"name":185,"class":45},"Hinge Bio",{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":192,"maxAge":146,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":77},"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":194,"type":22},50,[59],"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.",[33,28],[62,199,200,201,202],"LN","Belimumab","Lupus Nephritis","Telitacicept","2026-03-10",{"date":205,"type":38},"2026-03-12",{"date":207,"type":38},"2025-12-08",{"date":209,"type":22},"2029-06",{"name":211,"class":76},"Nanjing University School of Medicine",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":219,"maxAge":146,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":77},"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":221,"type":22},18,[25,59],"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).",[33,28],[33,28,226],"CD19 CAR-T","2026-03-06",{"date":203,"type":38},{"date":230,"type":38},"2024-10-17",{"date":232,"type":22},"2026-12-31",{"name":138,"class":76},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":77},"100611144","phase-1-an-exploratory-clinical-study-of-yts109-cell-for-rr-autoimmune-diseases-100611144","NCT07236762","An Exploratory Clinical Study of YTS109 Cell for R\u002FR Autoimmune Diseases","An Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell in Subjects With Relapsing\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Essential Organ Function Criteria:\n\n\u003C!-- -->\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 3. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n4\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1. Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE);\n2. Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows:\n\n\u003C!-- -->\n\n1. Refractory Lupus Nephritis:\n\n   1. Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.).\n   2. Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening.\n   3. Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n2. Refractory SLE-Associated Immune Thrombocytopenia:\n\n   1. Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n\n      Relapsing and refractory Sjögren's syndrome:\n      1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n      2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n      3. Testing positive for anti-SSA\u002FRo antibodies;\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\n         Relapsing and refractory Sjogren's Syndrome:\n\n      \u003C!-- -->\n\n      1. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;\n      2. Testing positive for systemic sclerosis-related antibodies;\n      3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n      5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\n      Note: Meeting either criterion 4 or 5 is sufficient.\n\n      Relapsing and refractory Inflammatory Myopathy:\n      1. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM);\n      2. Testing positive for myositis-specific antibodies;\n      3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n      5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\n      Note: Meeting either criterion 4 or 5 is sufficient.\n\n      Relapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n      1. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n      2. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n      3. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n      4. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\n         Relapsing and refractory Antiphospholipid Syndrome:\n\n      1\\. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\n      Note: Meeting either criterion 3 or 4 is sufficient.\n\n      Exclusion Criteria:\n      * Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n        1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n        2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n        3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n        4. Subjects whose cardiac function cannot tolerate the study interventions;\n        5. Subjects with congenital immunoglobulin deficiencies;\n        6. Subjects with a history of malignant tumors within the past five years;\n        7. Subjects with end-stage renal failure;\n        8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n        9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n        10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n        11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n        12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n        13. Pregnant women or women planning to become pregnant;\n        14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":221,"type":22},[25],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Bengbu Third People's Hospital.",[245,28,246,247,248,249],"Systemic Lupus Erythematosus","Sjogren's Syndrome","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Antiphospholipid Syndrome","2026-03-02",{"date":252,"type":38},"2026-03-04",{"date":254,"type":38},"2025-11-24",{"date":256,"type":22},"2027-11-24",{"name":258,"class":45},"China Immunotech (Beijing) Biotechnology Co., Ltd.",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":77},"100602439","phase-1-a-clinical-study-of-yts109-cells-for-the-treatment-of-rr-autoimmune-diseases-100602439","NCT07123519","A Clinical Study of YTS109 Cells for the Treatment of R\u002FR Autoimmune Diseases","An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\nSubjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\n* Common inclusion criteria:\n\n  1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n  2. Essential Organ Function Criteria:\n\n     2.1 Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n\n     2.2 Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).\n\n     2.3 Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines). 2.4 Coagulation: INR\u002FPT ≤1.5×ULN. 2.5 Cardiovascular: Hemodynamic stability.\n  3. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n  4. Voluntary participation with signed informed consent and compliance.\n* Specific inclusion criteria:\n\n  1. Relapsing and refractory systemic lupus erythematosus:\n\n     1.1 Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE); 1.2 Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows: 1.2.1 Refractory Lupus Nephritis:(1)Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.). (2)Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening. (3)Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n\n     1.2.2 Refractory SLE-Associated Immune Thrombocytopenia: Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n  2. Relapsing and refractory Sjögren's syndrome:\n\n     2.1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome; 2.2 Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6; 2.3 Testing positive for anti-SSA\u002FRo antibodies; 2.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n  3. Relapsing and refractory Sjogren's Syndrome:\n\n     3.1 Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis; 3.2 Testing positive for systemic sclerosis-related antibodies; 3.3 Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 3.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 3.5 Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\n     Note: Meeting either criterion 4 or 5 is sufficient.\n  4. Relapsing and refractory Inflammatory Myopathy:\n\n     4.1 Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM); 4.2 Testing positive for myositis-specific antibodies; 4.3 For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 4.5 Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\n     Note: Meeting either criterion 4 or 5 is sufficient.\n  5. Relapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n     5.1 Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n     5.2 Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n\n     5.3 A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n\n     5.4 Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n  6. Relapsing and refractory Antiphospholipid Syndrome:\n\n6.1 Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 6.2 Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 6.3 Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 6.4 For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n4. Subjects whose cardiac function cannot tolerate the study interventions;\n5. Subjects with congenital immunoglobulin deficiencies;\n6. Subjects with a history of malignant tumors within the past five years;\n7. Subjects with end-stage renal failure;\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n13. Pregnant women or women planning to become pregnant;\n14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":221,"type":22},[25],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3E6 STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Institute of Hematology \\& Blood Diseases Hospital.",[33,28,270,247,248,271],"Sjogren's Syndrome (SS)","Antiphospholipid Syndrome (APS)",[273],"Relapsing\u002FRefractory Autoimmune Diseases","2026-02-27",{"date":250,"type":38},{"date":277,"type":38},"2025-08-13",{"date":279,"type":22},"2027-08-13",{"name":258,"class":45},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":239,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":297,"locationsCount":77},"100600994","phase-1-a-clinical-study-of-yts109-cell-for-rr-autoimmune-diseases-100600994","NCT07104721","A Clinical Study of YTS109 Cell for R\u002FR Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1\\. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n\n2\\. Essential Organ Function Criteria:\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 3. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n4\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1. Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE);\n2. Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows:\n\n\u003C!-- -->\n\n1. Refractory Lupus Nephritis:\n\n   * Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.).\n   * Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening.\n   * Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n2. Refractory SLE-Associated Immune Thrombocytopenia:\n\n   * Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n\nRelapsing and refractory Sjögren's syndrome:\n\n1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n3. Testing positive for anti-SSA\u002FRo antibodies;\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Sjogren's Syndrome:\n\n1\\. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis; 2. Testing positive for systemic sclerosis-related antibodies; 3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Inflammatory Myopathy:\n\n1\\. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM); 2. Testing positive for myositis-specific antibodies; 3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n1\\. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n2\\. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n\n3\\. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n\n4\\. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Antiphospholipid Syndrome:\n\n1. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome;\n2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period);\n3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide;\n4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nExclusion Criteria:\n\n\\- Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n4. Subjects whose cardiac function cannot tolerate the study interventions;\n5. Subjects with congenital immunoglobulin deficiencies;\n6. Subjects with a history of malignant tumors within the past five years;\n7. Subjects with end-stage renal failure;\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n13. Pregnant women or women planning to become pregnant;\n14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":221,"type":22},[25],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across The First Affiliated Hospital of Anhui Medical University.",[33,28,291,247,248,271],"Systemic Sclerosis (SSc)",[273],{"date":250,"type":38},{"date":295,"type":38},"2025-08-04",{"date":161,"type":22},{"name":258,"class":45},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":77},"100587983","phase-1-c-car168-car-t-cell-therapy-for-refractory-autoimmune-disease-100587983","NCT06935474","C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease","Multi-center, Phase 1\u002F2 Study of an Autologous Anti-CD20\u002FBCMA CAR T Cell Therapy (C-CAR168) for the Treatment of Autoimmune Disease Refractory to Standard Therapy","Inclusion Criteria:\n\n1. Informed Consent: Voluntary signed consent required.\n2. Age \\& Gender: Males and females, 18-70 years old.\n3. Diagnosis: Clinical diagnosis of SLE per EULAR\u002FACR criteria for at least 6 months.\n4. Lupus Nephritis (LN): Biopsy-confirmed active proliferative LN (Class III\u002FIV ± V) within the past 12 months.\n5. Refractory Disease:\n\n   * Treated with at least two immunosuppressants for ≥8 weeks.\n   * Stable but active disease despite standard therapy (steroids, IS, monoclonal antibodies).\n   * Steroid dose ≤30 mg\u002Fday (if applicable).\n6. Disease Activity at Screening:\n\n   * SLE without LN: SLEDAI-2K ≥8 and 1 BILAG A or 2 BILAG B scores.\n   * LN Patients: Proteinuria ≥1.0 g\u002Fday or UPCR ≥1.0 g\u002Fg.\n7. Autoantibody Status:\n\n   o Positive ANA (≥1:80), anti-dsDNA (≥30 IU\u002FmL), and\u002For anti-Smith antibody.\n8. Infection Status: No active infection within 2 weeks before leukapheresis.\n9. Life Expectancy: Greater than 6 months.\n10. Adequate Organ Function:\n\n    * Bone Marrow: ANC ≥1.0×10⁹\u002FL, ALC ≥0.5×10⁹\u002FL, Hb ≥80 g\u002FL, PLT ≥75×10⁹\u002FL.\n    * Coagulation: INR\u002FAPTT ≤1.5×ULN.\n    * Cardiac: LVEF ≥45% by ECHO\u002FMUGA.\n    * Pulmonary: SpO₂ ≥92% on room air.\n    * Liver: ALT\u002FAST ≤2.5×ULN, total bilirubin \\\u003C2.0 mg\u002FdL.\n    * Renal: Creatinine clearance ≥40 mL\u002Fmin (Cockcroft-Gault).\n11. Pregnancy \\& Contraception:\n\n    * Women of childbearing potential must have a negative pregnancy test at screening.\n    * Both male and female participants must use highly effective contraception for 1 year post-treatment.\n\nExclusion Criteria:\n\n1. Any other concomitant diseases requiring long term systemic steroids (oral or intravenously) treatment that may confound the interpretation of study results or have interference with background steroid tapering for the subjects.\n2. Any of the following:\n\n   * Positive for Hepatitis B surface antigen (HBsAg)\u002Fcore antibody (HBcAb)\u002Fe antibody (HBeAb)\u002Fe antigen (HBeAg).\n   * Positive for Hepatitis C Virus (HCV) antibodies.\n   * Positive for Human Immunodeficiency Virus (HIV) antibodies.\n   * Positive for syphilis antigen or antibody.\n3. Have an uncontrolled active infection.\n4. History of major organ transplantation (such as heart, lung, liver, kidney) or history of bone marrow\u002Fhematopoietic stem cell transplantation.\n5. History of any of stroke, unstable angina, myocardial infarction, congestive heart failure (NYHA Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening.\n6. History of ≥ Grade 2 bleeding within the past 30 days.\n7. Received a live vaccine within 4 weeks prior to signing the ICF.\n8. Received any of the following treatments:\n\n   * Prednisone treatment of ≥ 100 mg\u002Fd or equivalent corticosteroid therapy for ≥14 days within the previous 8 weeks.\n   * Receive plasma exchange, plasma separation, hemodialysis, or intravenous injection of immunoglobulin (IVIG) within 14 days prior to leukapheresis.\n   * Use of any other investigational clinical study drug within 28 days prior to leukapheresis. However, if the subject is not responsive to the treatment or have progressed and at least 3 half-lives have passed before the leukapheresis, he\u002Fshe could be enrolled.\n   * Previously received any CAR-T cell products or other genetically modified T cell therapies.\n   * Rituximab\u002Focrelizumab\u002Fobinutuzumab within 6 months prior to screening\n9. Pregnant or breastfeeding women.\n10. History of seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia or cerebellar disease or other severe neuropsychiatric syndromes.\n11. History of deep vein thrombosis or pulmonary embolism within six months of infusion (line associated DVT is allowed)\n12. Diagnosed with malignant tumors within 5 years prior to signing the ICF, with the following exceptions: non-melanoma skin cancer that has been treated with radical therapy, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely excised breast carcinoma in situ.\n13. Poor compliance, unwilling or unable to adhere to the study protocol based on the investigator's assessment.\n14. Allergies to fludarabine, cyclophosphamide and\u002For known allergies to excipients of C-CAR168 cell product.",{"count":57,"type":22},[25,59],"This multi-center, open-label, Phase 1\u002F2 study aims to evaluate the safety, tolerability, and preliminary efficacy of C-CAR168, an autologous anti-CD20\u002FBCMA CAR-T therapy, in patients with autoimmune diseases refractory to standard treatments. The study includes both dose escalation and dose expansion phases, with participants grouped into condition-specific cohorts.\n\nThe purpose of this study is to:\n\n1. Test the safety and ability for subjects with autoimmune refractory to standard treatment to tolerate the C-CAR168.\n2. Determine the recommended Phase 2 dose of C-CAR168 in subjects with autoimmune disease refractory to standard treatment.\n\nParticipants will be asked to:\n\n* Undergo screening to determine eligibility based on entry criteria.\n* Taper steroid use before leukapheresis.\n* Undergo leukapheresis for the manufacturing of C-CAR168.\n* Temporarily discontinue immunosuppressive therapy at least 7 days prior to leukapheresis.\n* Receive bridging therapy (steroids) if necessary to maintain disease stability during C-CAR168 manufacturing.\n* Undergo lymphodepletion therapy with fludarabine and cyclophosphamide.\n* Receive a single intravenous infusion of C-CAR168 at the assigned dose level on Day 0.\n* Attend regular safety and efficacy assessments for up to 24 months post-infusion.\n* Undergo dose-limiting toxicity evaluation during the first 28 days post-infusion (for those in the dose escalation phase).\n* Follow withdrawal procedures if necessary, including a discharge visit within 14 days if their condition deteriorates, unacceptable toxicity occurs, they no longer meet criteria, or they choose to withdraw.",[28],[310,311,245,312,313,314,315],"Autoimmune","Lupus Nepritis","CAR-T","CD20","C-CAR168","BCMA","2026-02-02",{"date":318,"type":38},"2026-02-03",{"date":320,"type":22},"2026-07",{"date":322,"type":22},"2030-06",{"name":324,"class":45},"AbelZeta Inc.",{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":333,"targetDuration":335,"studyType":336,"phases":4,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":77},"100587348","research-accelerated-by-you-lupus-registry-100587348","NCT06927219","Research Accelerated by You Lupus Registry","Web-Based Data Collection Through the Research Accelerated by You (RAY) Lupus Registry","RAY","Inclusion Criteria:\n\n* For adults with lupus, the individual who completes the Registry:\n\n  * is 18 years of age or older\n  * has a self-reported diagnosis of lupus by a physician or health care provider\n  * is willing and able to provide informed consent\n  * is able to read and understand English sufficiently to complete the survey questions\n  * has access to a computer with an internet connection\n\nFor children under 18 with lupus, the individual who completes the Registry is:\n\n* 18 years of age or older\n* the parent\u002Flegal guardian\u002Flegally authorized representative of a child under 18 years of age that has a diagnosis of lupus by a physician or health care provider\n* willing and able to provide consent for the child under 18 years of age and to obtain assent from the child between 7-17 years of age\n* able to access a computer with an internet connection\n* able to read and understand English sufficiently to complete the survey questions\n\nFor adults with lupus unable to provide consent, the individual who completes the Registry is:\n\n* 18 years of age or older\n* the legally authorized representative of an adult 18 or older who is unable to provide consent and has a diagnosis of lupus by a physician or health care provider\n* willing and able to provide consent for the adult with lupus\n* able to access a computer with an internet connection\n* able to read and understand English sufficiently to complete the survey questions\n\nExclusion Criteria:\n\n* People who are not living with lupus",{"count":334,"type":22},10000,"10 Years","OBSERVATIONAL","Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus. The primary goal is to better understand the diagnosis, treatment, care, and quality of life for those affected by the disease.\n\nRemote Participation This is a decentralized, online-only registry. Participation is conducted entirely through a secure web-based portal. There are no physical site visits or travel requirements; participants can contribute from any location with internet access.\n\nParticipation Details\n\nConsent: Informed consent is completed electronically.\n\nSurveys: Participants complete electronic surveys upon enrollment and every six months thereafter.\n\nData Types: Collected data is self-reported and includes demographics, diagnosis history, treatment information, and patient-reported outcomes (PROs), such as quality of life.\n\nPurpose and Data Use The LFA uses registry data to:\n\nAddress Constituent Needs: Inform programs and resources for the lupus community.\n\nAdvance Research: Share patient insights with to ensure therapies are developed with the consideration of what matters and what matters most to people living with lupus.\n\nPatient Engagement and Clinical Research Matching: Participants may be contacted to assess eligibility for patient engagement or clinical research opportunities or to complete specific sub-surveys regarding trial participation.",[33,28,339],"Cutaneous Lupus Erythematosus (CLE)",[341,342],"lupus","registry","2026-01-22",{"date":345,"type":38},"2026-01-23",{"date":347,"type":38},"2020-10-01",{"date":349,"type":22},"2050-12-31",{"name":351,"class":76},"Lupus Foundation of America",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":360,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":372,"locationsCount":4},"100620959","phase-1-efficacy-and-safety-of-crc01-in-participants-with-severe-refractory-systemic-lupus-erythematosus-100620959","NCT07364396","Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus","An Open-label, Multi-center, Single-arm Phase 1\u002F2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus","CRC01-02","Inclusion Criteria:\n\n* Age 19 years or older, voluntarily provides written informed consent.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria.\n* Positive antinuclear antibody (ANA) at screening (titer ≥1:80).\n* Diagnosis of lupus nephritis Class III or IV (with or without concurrent Class V), confirmed by kidney biopsy within 1 year prior to screening based on ISN\u002FRPS 2018 criteria.\n* Inadequate response to, or intolerance of, at least two or more standard therapies for 6 months or longer (cyclophosphamide, mycophenolate mofetil, azathioprine, tacrolimus, rituximab, belimumab).\n* Proteinuria at screening with urine protein-to-creatinine ratio (UPCR) \\>1.5.\n* Adequate laboratory values at screening: Hemoglobin \\>8.0 g\u002FdL; ANC \\>1,000\u002FμL; Platelets ≥50,000\u002FμL; Total bilirubin ≤2.0 × ULN; AST and ALT ≤3 × ULN; eGFR ≥30 mL\u002Fmin\u002F1.73 m².\n* Hemodynamically stable, no pericardial effusion, and LVEF ≥50% by echocardiogram at screening.\n* FEV1\u002FFVC ≥70% at screening.\n* Willing and able to comply with study visits, procedures, and requirements.\n* Women of childbearing potential and men must agree to use effective contraception for at least 1 year after CRC01 infusion until PCR testing confirms clearance of CRC01.\n\nExclusion Criteria:\n\n* Current or anticipated requirement for renal dialysis during the study.\n* History of kidney transplantation or planned transplantation during the study.\n* History of severe CNS lupus or currently active severe CNS lupus.\n* Prior CAR-T cell therapy.\n* History of malignancy except for: basal or squamous cell carcinoma of skin treated and disease-free ≥3 years; in-situ carcinoma of cervix or breast treated and disease-free ≥3 years; superficial bladder cancer treated and disease-free ≥3 years; completely resected primary malignancy in complete remission ≥5 years.\n* Unstable angina and\u002For myocardial infarction within 1 year prior to screening.\n* Congestive heart failure of NYHA Class III or IV within 1 year prior to screening.\n* Thromboembolism, pulmonary embolism, or clinically significant bleeding diathesis within 6 months prior to screening.\n* Hypoxemia, clinically significant pleural effusion, or abnormal ECG findings within 6 months prior to screening.\n* Stroke (ischemic or hemorrhagic) within 6 months prior to screening.\n* Positive HBsAg; positive anti-HCV (eligible if HCV RNA negative); known HIV infection; or active neurological autoimmune\u002Finflammatory diseases (e.g., Guillain-Barré syndrome, ALS).\n* Recurrent or symptomatic ventricular tachycardia, or atrial fibrillation with rapid ventricular response despite therapy within 3 months prior to screening.\n* Severe or uncontrolled active infection requiring systemic therapy at screening.\n* Rapidly progressive disease or otherwise unsuitable for study participation, per investigator judgment.\n* Pregnant or breastfeeding women.\n* Known hypersensitivity to investigational product components.\n* Participation in another investigational study within 4 weeks prior to screening.\n* Receipt of systemic corticosteroids at therapeutic doses within 7 days prior to leukapheresis (≤7.5 mg\u002Fday prednisone equivalent is permitted).\n* Receipt of immunosuppressive agents within 7 days prior to leukapheresis.\n* Receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to leukapheresis.\n\nInclusion Criteria for CRC01 Infusion:\n\n* No clinically significant worsening of organ function after screening.\n* If any of the following adverse events related to lymphodepleting chemotherapy exceed Grade 1 or worsen compared with screening, CRC01 infusion must be delayed:\n\n  * Requirement for supplemental oxygen\n  * New arrhythmia symptoms or clinically significant changes in cardiac function compared with screening\n  * Hypotension requiring treatment\n  * Active infection within 72 hours prior to the planned CRC01 infusion\n\n    * If bacterial, viral, or fungal infection is documented, improvement of symptoms must be documented before infusion.\n* Women of childbearing potential must have a negative urine pregnancy test prior to infusion.\n* If CRC01 infusion is delayed for more than 2 weeks after lymphodepleting chemotherapy, administration may proceed only with approval from the sponsor's medical monitor.\n* No receipt of therapeutic doses of systemic corticosteroids or immunosuppressive agents within 7 days prior to CRC01 infusion. (Prednisone ≤7.5 mg\u002Fday or equivalent is permitted.)\n* No receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to CRC01 infusion.","19 Years",{"count":362,"type":22},39,[25,59],"The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE).\n\nThe main objectives of the study are:\n\n1. To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis.\n2. To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity.\n\nStudy Design This is a single-arm, open-label, multi-center, Phase 1\u002F2 study. All enrolled participants will receive CRC01 after screening and baseline assessments.\n\nStudy Procedures\n\nParticipants will:\n\n* Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments.\n* Provide autologous T lymphocytes through a procedure called leukapheresis.\n* Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy).\n* Receive a single intravenous infusion of CRC01 cells.\n* Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity.\n* Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response.\n\nKey Outcomes\n\nResearchers will measure:\n\n* Changes in proteinuria and kidney function.\n* Changes in disease activity scores.\n* Incidence and severity of adverse events.",[201,28,62,366],"SLE (Systemic Lupus)","2026-01-21",{"date":345,"type":38},{"date":370,"type":22},"2026-02",{"date":322,"type":22},{"name":373,"class":45},"Curocell Inc.",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":77},"100620887","phase-2-study-to-assess-efficacy-and-safety-of-hsk39297-tablets-in-patients-with-ln-100620887","NCT07363460","Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Lupus Nephritis","Inclusion Criteria:\n\n1. Understand and comply with the research requirements, voluntarily participate in the research and sign the informed consent form before starting the relevant procedures;\n2. Age ≥ 18 and \\\u003C 75 years old at screening, gender not limited;\n3. Positive anti-ANA antibody and\u002For anti-dsDNA antibody (research center);\n4. Pathological type of active III or IV lupus nephritis confirmed by renal biopsy within 12 months before screening, with or without type V (adopting the 2003 International Society of Nephrology\u002FRenal Pathology Working Group's lupus nephritis pathological classification criteria, see Appendix 2; for recurrent subjects, the investigator assesses whether a repeat renal biopsy is necessary; renal biopsy is conducted after confirming that the subject meets all other inclusion criterias and does not meet the exclusion criterias);\n5. Evidence of active lupus nephritis exists, and the investigator assesses that it is necessary to receive glucocorticoid combined with MMF treatment. Active lupus nephritis must meet the following two criterias:\n\n   a) Proteinuria:\n\n   a) At screening: 24h-UPCR ≥ 1g\u002Fg or FMV-UPCR ≥ 1g\u002Fg or FMV-UACR ≥ 0.5g\u002Fg; b) Before randomization: 24h-UPCR ≥ 1g\u002Fg (central laboratory); b) At screening: SLEDAI-2000 ≥ 8;\n6. First onset or recurrence of lupus nephritis (for subjects who have received MMF treatment previously and have experienced recurrence, the investigator and the sponsor jointly assess the benefit based on the study's medication regimen to determine whether they can be enrolled);\n7. Female subjects with reproductive capacity \\[excluding those who have undergone surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 6 weeks prior to screening or who are postmenopausal (defined as having no menstruation for 12 months, with no other medical cause)\\]; a negative pregnancy test must be confirmed during the screening period. The subject must agree not to attempt pregnancy and not to donate oocytes from the date of signing the informed consent form until at least 30 days after the last administration of investigational product, and must use effective contraception; male subjects must agree not to donate sperm for at least 90 days from the date of signing the informed consent form until at least 90 days after the last administration of investigational product, and must use highly effective contraception with their female partners (see Appendix 3).\n\nExclusion Criteria:\n\n1. The subject has previously failed to respond to treatment with MMF or other mofetil mycophenolate drugs, as assessed by the investigator.\n2. Allergy to the investigational product or MMF, or contraindications to MMF and glucocorticoids.\n3. Currently receiving or requiring administration of any drug listed in Section 5.7.2.2 \"Prohibited Concomitant Medications\" during the study period.\n4. Receiving systemic glucocorticoid therapy for reasons other than systemic lupus erythematosus or lupus nephritis at screening (dose \\> 10 mg\u002Fday prednisone or equivalent; dosage conversion details see Appendix 4).\n5. Received treatment with other investigational drugs within 30 days prior to screening or within 5 half-lives (whichever is longer).\n6. Presence of rapidly progressive glomerulonephritis at screening (eGFR decline exceeding 50% within 3 months, or less than 50% but with rapid decline risk assessed by the investigator); renal biopsy showing crescents occupying more than 50% of glomeruli, or glomerulosclerosis exceeding 60%, or tubular atrophy\u002Finterstitial fibrosis exceeding 60%.\n7. Presence of severe extra-renal manifestations of systemic lupus erythematosus at screening, including but not limited to severe pulmonary hypertension (WHO classification IV or higher), severe pulmonary interstitial fibrosis, severe myocarditis, severe heart failure (NYHA classification IV), or active central nervous system lupus.\n8. Major, unstable, or uncontrolled acute or chronic diseases affecting various systems (e.g., cardiovascular, respiratory, hematological, gastrointestinal, hepatic, renal, neurological systems) within 6 months prior to screening or at screening that may affect study results or place the subject at high risk, excluding those caused by SLE.\n9. History of other autoimmune diseases.\n10. History of any of the following infections:\n\n1\\) History of encapsulated bacterial infection (e.g., Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae) within 1 year prior to screening; 2) Active tuberculosis at screening; history of active tuberculosis within 2 years prior to screening; history of active tuberculosis currently cured but assessed by the investigator to be at risk for reactivation; positive interferon-gamma release assay with determination by the investigator or consulting specialist physician that it represents latent tuberculosis requiring prophylactic anti-tuberculosis treatment; 3) History of other active infections requiring antimicrobial treatment within 3 months prior to screening.\n\n11\\. History of major organ (heart, lung, kidney, liver) transplantation or hematopoietic stem cell\u002Fbone marrow transplantation, or planned for transplantation.\n\n12\\. Currently undergoing regular hemodialysis or planning to undergo hemodialysis during the study period.\n\n13\\. History of gastrointestinal surgery that may significantly affect drug absorption, distribution, metabolism, and excretion, or history of severe gastrointestinal disease, or difficulty in swallowing, frequent vomiting leading to difficulty in eating or taking medication.\n\n14\\. Diagnosis of malignancy within 5 years prior to screening, excluding basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.\n\n15\\. Major surgical procedures within 6 months prior to screening. 16. Laboratory tests at screening meet any of the following criteria:\n\n1. Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m² (calculated by CKD-EPI 2021 formula, see Appendix 5);\n2. Hematology: neutrophils \\\u003C 1 × 10⁹\u002FL; leukocytes \\\u003C 2 × 10⁹\u002FL; hemoglobin \\\u003C 80 g\u002FL; platelets \\\u003C 50 × 10⁹\u002FL;\n3. Liver function: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 3 × ULN; Total Bilirubin (TBIL) ≥ 2 × ULN;\n4. Hepatitis B virus surface antigen (HBsAg) positive, or HBsAg negative but Hepatitis B virus core antibody (HBc-Ab) positive with HBV-DNA detection result higher than the quantitative lower limit; Hepatitis C virus antibody (HCV-Ab) positive;\n5. Human Immunodeficiency Virus antibody (HIV-Ab) positive. 17. Pregnant or lactating female subjects at screening. 18. Other situations deemed unsuitable for participation by the investigator.",{"count":382,"type":22},105,[59],"A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis",[28],"2026-01-14",{"date":345,"type":38},{"date":389,"type":38},"2025-11-18",{"date":391,"type":22},"2028-07-06",{"name":393,"class":45},"Haisco Pharmaceutical Group Co., Ltd.",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":401,"maxAge":86,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":407,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":4},"100618204","phase-1-bcma-cd19-ccar-t-for-the-treatment-of-refractory-lupus-100618204","NCT07328581","BCMA-CD19 cCAR T for the Treatment of Refractory Lupus","Phase I, IIa, Single-Arm, Study of BCMA-CD19-IL-15\u002FIL15sushi cCAR T for the Treatment of Refractory Systemic Lupus Erythematosus, With or Without Lupus Nephritis","Key Inclusion Criteria:\n\n1. Age 16-70 years at the time of signing the informed consent\n2. Have a diagnosis of SLE by EULAR\u002FACR 2019 criteria for ≥6 months.\n3. Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody\n4. Inadequate response to 2 prior standard of care therapies, used for at least three months\n5. SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening\n6. For LN cohort participants. Kidney biopsy result within 6 months prior to Screening indicating Class III or IV (alone or in combination with Class V)6.\n\nKey Exclusion Criteria:\n\n1. Any acute, severe lupus related flare that needs immediate treatment\n2. History of antiphospholipid syndrome with thromboembolic event within 12 months\n3. History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study.\n4. Has drug-induced SLE.\n5. History of prior CAR-T therapy.\n6. History of bone marrow\u002Fhematopoietic stem cell or solid organ transplant or planned receipt during the study period.\n7. Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection\n8. Receipt of a live\u002Flive-attenuated vaccine other than BCG within 8 weeks\n9. History within the past year or current clinically significant central nervous system disease, including but not limited to cerebrovascular accident, seizures, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or multiple sclerosis\n10. Impaired cardiac function or clinically significant cardiac disease\n11. End stage renal disease or severe liver disease\n12. Breastfeeding\u002Flactating or pregnant women or women who intend to become pregnant at any time during the study.","16 Years",{"count":403,"type":22},20,[25,59],"This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19-IL-15\u002FIL15sushi cCAR T cells in patients with relapsed and\u002For refractory SLE, with or without Lupus Nephritis.",[33,28],[66,408,409,410,411,315,28,412],"autoimmune disease","CAR-T Cell","Refractory disease","CD19","Systemic Lupus Erythrematosus (SLE)","2026-01-07",{"date":415,"type":38},"2026-01-09",{"date":417,"type":22},"2026-01",{"date":419,"type":22},"2028-12",{"name":421,"class":45},"iCell Gene Therapeutics",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":438,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":77},"100601220","early-phase-1-safety-and-efficacy-of-ont01-in-lupus-100601220","NCT07107659","Safety and Efficacy of ONT01 in Lupus","Safety and Efficacy of ONTO1 in Lupus","Inclusion Criteria:\n\n1. ≥ 18 years old and able to provide informed consent to participate.\n2. Diagnosis of SLE and have fulfilled the ACR classification criteria for SLE during the course of their disease.\n3. Active non-renal SLE, with one active non-renal clinical manifestation, who have failed at least 1 disease modifying anti-rheumatic drug (DMARD) therapy (not including hydroxychloroquine and corticosteroids)\n\n   * Active non-renal SLE is defined as having a SLEDAI of 6 or greater (with at least 1 non-renal clinical domain) OR Active nephritis defined as having a no or partial response after initial induction and maintenance therapy with mycophenolate mofetil (and other standard of care therapies) for 3 months or more for class III, IV, IV, V (or combination) nephritis.\n   * Active LN is defined as follows: a. kidney biopsy showing Class III, IV, V, III+V, or IV+V, within 1 year from screening, AND b. 24-hour urine protein\u002Fcreatinine ratio \\>=1g\u002Fg at screening, AND c. absence of partial renal response (PRR)\n   * Partial renal response (PRR) is defined as a. 24-hour UPCR improved by \\>=25% after 3 months from the start of induction standard of care (SOC) therapy (baseline), or \\>= 50% after 6 months from the induction therapy (UPCR), AND b. 24-hour UPCR\\\u003C2g\u002Fg if baseline was \\\u003C 3g\u002Fg, OR \\\u003C 3g\u002Fg if baseline at induction was \\>= 3g\u002Fg. AND d. EGFR\\>=60 ml\u002Fmin\u002F1.73 M2 or no less than 80% of Baseline eGFR (at induction) AND e. No intercurrent rescue therapy, death, or early SOC treatment discontinuation or study withdrawal No response (NR) is defined as a. no achievement of at least a partial renal response, OR b. use of intercurrent rescue therapy, OR c. death\n4. Female patients who are women of childbearing potential must agree to use a highly effective form of contraception during the study and for at least 120 days after last exposure to study drug. Male patients with female partners of childbearing potential must use effective barrier contraception (i.e., condoms) during the study and for at least 120 days after last exposure to study drug. Also, patients may not proceed with sperm or egg donation during the study and for at least 120 days after the last exposure to study drug\n\nExclusion Criteria:\n\n1. Any condition, including any uncontrolled disease (eg, asthma, interstitial lung disease, pulmonary arterial hypertension, morbid obesity), that in the Sponsor-Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation.\n2. Active central nervous system SLE associated with significant cognitive impairment leading to inability to provide informed consent and\u002For comply with the protocol.\n3. Comorbidities requiring systemic corticosteroid (CS) therapy, such as asthma or inflammatory bowel disease. Systemic is defined as oral, rectal or any injectable route of administration (thus stable dosing by other routes is allowed, including inhaled, topical, ophthalmic, otic, and intranasal).\n4. Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of or during the Screening Visit, or completion of oral anti-infectives within 2 weeks before or during the Screening Visit.\n5. History of positive human immunodeficiency virus (HIV), hepatitis C antibody and\u002For polymerase chain reaction, hepatitis B surface antigen (HBsAg) (+), and\u002For hepatitis B core IgG and\u002For IgM antibody (+) at the Screening Visit.\n6. History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection (LTBI), determined by a positive QuantiFERON test at the Screening Visit\n7. History of malignancy (hematologic or solid tumor) within 10 years prior to Screening Visit, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or adequately treated carcinoma in situ\u002Fcervical intraepithelial neoplasia of the uterine cervix.\n8. Immunization with live or live-attenuated vaccines within 1 month before or during the Screening period.\n9. Initiation of, or change in, dosing of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker within 2 weeks before the Screening Visit or during the Screening period.\n10. Treatment with Voclosporin or Cyclophosphamide at time of screening.\n11. Treatment with other investigational agents within the last 3 months or 5 half-lives, or as per washout requirement from the previous protocol, whichever is longest, prior to the Screening Visit.\n12. Clinically significant abnormalities in laboratory tests, unless attributable to active SLE at the Screening Visit\n\n    * Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level \\> 2.5 × upper limit of normal (ULN), or\n    * Total bilirubin \\> 1.5 × ULN, or\n    * Hemoglobin \\\u003C 5.0 mmol\u002FL \\[9 g\u002FdL\\], or\n    * White blood cells \\\u003C 2.5 × 109\u002FL, or\n    * Absolute neutrophil count \\\u003C 1500 \u002Fmm3, or\n    * Platelets \\\u003C 75 × 109\u002FL\n13. Clinically significant chest imaging (e.g. X-ray, computed tomography or magnetic resonance imaging \\[MRI\\]) abnormalities per Sponsor-Investigator opinion (e.g. interstitial lung disease) or evidence of active TB on chest X-ray. Chest imaging study must have been performed in 3 months prior to the Screening Visit or during the Screening period.\n14. Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n15. Patients are unable or unwilling to adhere to the contraception requirements outlined in inclusion criteria 4.",{"count":430,"type":22},61,[150],"ONT01 is a drug that is being studied for the treatment of Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) and is not approved by the FDA. The purpose of this study is to better determine whether ONT01 is safe and tolerated by people with lupus nephritis or SLE. The study also looks at how the administration of ONT01 in combination with widely used treatments given for lupus, including the medication mycophenolate mofetil and others, can improve symptoms of lupus. A total of 61 participants will be enrolled in this study.",[28,434,435,436,66,62,245,437],"Lupus Nephritis - WHO Class III","Lupus Nephritis - WHO Class IV","Lupus Nephritis - World Health Organization (WHO) Class III","Systemic Lupus Erythematosus (Disorder)",[201,66,62],"2025-11-19",{"date":441,"type":38},"2025-11-20",{"date":443,"type":22},"2026-09-04",{"date":445,"type":22},"2030-05",{"name":447,"class":76},"Hospital for Special Surgery, New York",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":464,"locationsCount":46},"100595894","phase-2-a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-human-sialidase-fusion-protein-hlx79-in-combination-with-rituximab-injection-versus-placebo-in-patients-with-active-glomerulonephritis-100595894","NCT07038382","A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis","A Randomized, Controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of HLX79 (Human Sialidase Fusion Protein) in Combination With Rituximab Injection (HLX01, Anti-CD20 Antibody) Versus Placebo in Patients With Active Glomerulonephritis","Inclusion Criteria:\n\n1. Patients who voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures.\n2. Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF.\n3. Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening\n4. If a diagnosis of primary MN is confirmed, a renal biopsy pathological diagnosis prior to screening or a renal biopsy diagnosis obtained during screening should be available, or patients with nephrotic syndrome and a positive anti-PLA2R antibody test within 6 months prior to screening; secondary MN (secondary to infection, tumor, SLE, drugs, etc.) should be excluded; subjects should have received treatment with angiotensin-converting enzyme inhibitors (ACEIs)\u002Fangiotensin II receptor blocker (ARBs) at the highest tolerated dose judged by the investigator for 3 months prior to screening (unless intolerance to ACEI\u002FARB, contraindications to their use or a low blood pressure that could induce side effects, at the investigator's discretion) and also meet one of the following high-risk criteria:\n\n   * Urine protein \\> 8 g\u002F24 h at screening.(The above 3-month ACEI\u002FARB treatment observation period is not required)\n   * eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 and urine protein \\> 3.5 g\u002F24 h at screening\n5. Women of childbearing potential (WOCBP) must undergo a pregnancy test at screening and obtain a negative result.\n6. WOCBP or male subjects must agree to take effective contraceptive measures starting from signing the ICF until 12 months after the last dose of the investigational medicinal product (IMP).\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization.\n2. WOCBP or partners of male subjects who plan to become pregnant during the study.\n3. History of drug or alcohol abuse within 1 year prior to screening.\n4. Malignancy or increased risk of malignancy prior to screening: suspected and\u002For diagnosed with any malignancy (except for basal cell carcinoma, squamous cell carcinoma of skin in situ, or cervical carcinoma in situ occurring within 5 years prior to screening with no evidence of recurrence after treatment).\n5. History of organ transplantation or stem cell or bone marrow transplantation prior to screening, or plan to undergo the above-mentioned transplantations during the study.\n6. Complicated with primary immunodeficiency diseases, type 1 diabetes mellitus, and type 2 diabetes mellitus (Type 2 diabetic patients with a renal biopsy report within one year prior to screening that excludes diabetic nephropathy are eligible to participate in this study) before screening.\n7. Presence of the following diseases that are significantly unstable or poorly controlled at screening: cardiovascular disorder, hematological disease, respiratory disorder, digestive system disorder, endocrine and metabolic system disease, nervous system disorder or psychiatric disorders, skin and subcutaneous tissue disorders, musculoskeletal system disorder, immune system disorders, or Grade 3 or greater medical abnormalities (CTCAE v5.0), and the investigator believes that the subject should be excluded due to the above diseases or abnormalities, or the investigator believes that the above diseases or abnormalities may interfere with the interpretation of the study results.\n8. End-stage renal disease requiring kidney transplantation or dialysis, or oliguria (urine volume \\\u003C 400 mL\u002F24 h) at screening or prior to randomization.\n9. Acute, recurrent, or chronic infection (including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacterial infection) at screening,\n10. Infection requiring intravenous or intramuscular injection of anti-infective drugs within 2 months prior to randomization, or infection requiring hospitalization within 2 months prior to randomization.\n11. Lung CT or chest X-ray at screening suggesting tuberculosis infection or previous tuberculosis infection.\n12. Abnormalities in 12-lead ECG at screening, such as corrected QT (QTc) interval \\> 450 ms in males and corrected QT (QTc) interval \\> 470 ms in females (Fridericia's method).\n13. Abnormal results of the following laboratory tests at screening:\n\n    1. Hemoglobin \\\u003C 90 g\u002FL, or platelet count \\\u003C 100 × 109 L, or neutrophil count \\\u003C 1.5 × 109 L.\n    2. Alkaline phosphatase (ALP) \\> 2 × upper limit of normal (ULN), or total bilirubin (TB) \\> 2 × ULN, or alanine aminotransferase (ALT) \\> 2 × ULN, or aspartate aminotransferase (AST) \\> 2 × ULN, or blood amylase \\> 1.5 × ULN.\n    3. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2.\n    4. International normalized ratio (INR) \\> 2.5 (not on anticoagulant therapy).\n    5. Interferon gamma release assay positive.\n    6. Serological test positive for human immunodeficiency virus (HIV) antibodies.\n    7. Test results positive for treponema pallidum (syphilis).\n    8. Positive for hepatitis B virus (HBV) surface antigen (HBsAg), or positive for HBV core antibody (HBcAb) and HBV deoxyribonucleic acid (HBV-DNA).\n    9. Hepatitis C virus (HCV) infection (HCV antibody positive with HCV-RNA \\> ULN).\n14. History of serious drug allergy before screening: history of allergy to two or more drugs, or history of allergy or serious side effects to HLX01, HLX79, or their excipients, or history of anaphylaxis to intravascular injection of contrast agents, human or murine proteins, or monoclonal antibodies, or history of anaphylactic shock.\n15. History of or need for treatment with one of the following drugs prior to screening:\n\n    * Treatment with glucocorticoids, MMF (or other forms of mycophenolate) within 1 month prior to randomization\n    * Treatment with calcineurin inhibitors (CNIs) such as tacrolimus and cyclosporine A or other immunosuppressive agents within 3 months prior to randomization\n    * Treatment with alkylating agents such as cyclophosphamide (CYC) and ifosfamide within 6 months prior to randomization\n    * Subjects who still require treatment with glucocorticoids, MMF (or other forms of mycophenolate), or alkylating agents or other immunosuppressive agents during the study as judged by the investigator at screening.\n16. Have received treatment with abatacept, telitacicept, JAK inhibitors, thalidomide, lenalidomide, bortezomib, cladribine, belimumab, rituximab, or other targeted drugs (T lymphocytes, B lymphocytes, interleukin-1, interleukin-6, type I interferon, etc.) within 1 year prior to randomization.Subjects who have received B-cell depleting drugs (such as rituximab) within the past year are eligible to participate in this study if there is evidence that the number of CD19+ or CD20+ B cells have recovered to the lower limit of normal or above.\n17. Have received intravenous infusion of immunoglobulin or plasma exchange within 3 months prior to randomization.\n18. Have participated in a clinical study of other investigational medicinal products prior to screening, with an interval between this study and the previous study being too short: within 1 month prior to the first administration of this study or within 5 half-lives of the previous investigational medicinal product (whichever is longer). Or plan to participate in clinical studies of other investigational medicinal products before completing all scheduled assessments in this clinical study.\n19. Have participated in surgical or device clinical studies within 3 months prior to screening or plan to participate in other surgical or device clinical studies during this clinical study.\n20. Have received any live or live attenuated vaccine within 3 months prior to screening, or plan to receive any live or live attenuated vaccine during the study.\n21. Use of herbal medicines, traditional Chinese medicines, or local traditional remedies that have therapeutic effects for MN within 14 days prior to randomization.\n22. Unable to establish venous access due to poor tolerability or difficulty in finding veins, or unable or unwilling to undergo repeated venipuncture.\n23. Donated whole blood or blood components (more than 400 mL) or lost a large amount of blood (more than 400 mL) within 2 months prior to screening, or plan to donate whole blood or blood components during the study.\n24. The investigator has a clear reason to believe that participation in this study will damage the rights and interests of the subject.",{"count":57,"type":22},[59],"The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis.\n\nThe secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis.\n\nThe subjects will receive different doses of HLX79 (10, 20, or 30 mg\u002Fkg) or placebo, all in combination with HLX01. After the end of the first treatment period, subjects will enter a 20-week follow-up period and then undergo pre-second treatment period assessments. If the investigator determines that the subject does not require the second treatment period, the subject will continue in follow-up until completing the total 48-week follow-up period.",[153,28],"2025-11-14",{"date":389,"type":38},{"date":462,"type":38},"2025-08-05",{"date":445,"type":22},{"name":465,"class":45},"Shanghai Henlius Biotech",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":475,"studyType":336,"phases":4,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":4},"100602971","the-relation-of-albuminglobulin-ratio-and-plateletalbumin-ratio-to-lupus-nephritis-100602971","NCT07130448","The Relation of Albumin\u002FGlobulin Ratio and Platelet\u002FAlbumin Ratio to Lupus Nephritis","The Relation of Albumin\u002FGlobulin Ratio and Platelet\u002FAlbumin Ratio to Lupus Nephritis in Upper Egypt ( Single Center Study)","Inclusion Criteria:\n\n* Patients aged 18 years or older diagnosed as SLE according to 2019 ACR\u002FEULAR classification criteria and with lupus nephritis (LN) according to the ACR criteria.\n* Patients with available baseline laboratory investigations and renal biopsy.\n\nExclusion Criteria:\n\n* Patients with chronic liver disease, hematological disorders, or malignancies affecting albumin\u002Fglobulin ratio or platelet counts.\n* Patients on nephrotoxic medications not related to SLE management.\n* Recent infections or acute inflammatory conditions.",{"count":474,"type":22},120,"1 Year","Albumin\u002Fglobulin ratio and platelet\u002Falbumin ratio as a predictive non-invasive biomarker for lupus nephritis (LN) presence and severity",[28,478,479],"SLE - Systemic Lupus Erythematosus","Biomarkers","2025-08-15",{"date":482,"type":38},"2025-08-19",{"date":484,"type":22},"2025-09",{"date":486,"type":22},"2026-10",{"name":488,"class":76},"Assiut University",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":510,"leadSponsor":512,"locationsCount":4},"100595698","phase-4-sglt-2-inhibitors-on-albuminuria-in-chronic-kidney-disease-patients-with-lupus-nephritis-and-anca--associated-vasculitis-100595698","NCT07035834","SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis","SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis: Study Design and Protocol","Inclusion Criteria:\n\n* patients aged more than18 years with chronic kidney disease from stage 1 to3, secondary to confirmed LN, without active LN, and AAV\n\nExclusion Criteria:\n\n* 1\\) allergy or intolerance to SGLT2i exposure within 1month before screening; 2) recurrent urinary tract infections; 3) hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase levels \\>2 times the upper normal limits); 4) an eGFR ˂30 ml\u002Fmin\u002F1.73 m2; 5) DM type I and II.",{"count":497,"type":22},40,[90],"The goal of this clinical trial is to investigate the effect of the glifozines on albuminuria in chronic kidney disease patients affected by lupus nephritis and ANCA associated renal vasculitis. It will also learn about the safety of glifozines. The main questions it aims to answer are:\n\n* Does glifozines lower the albuminuria of participants with chronic kidney disease secondary to lupus nephritis and ANCA associated renal vasculitis?\n* What medical problems do participants have when taking glifozines?\n\nParticipants will:\n\n* Take glifozines every day for 6 months.\n* Baseline, 1 month and 6-month visits will be scheduled to collect demographic, clinical, biochemical, and urinary data.\n* A psychosocial assessment will be performed.",[28,501],"ANCA Associated Vasculitis (AAV)",[201,503,504,505],"ANCA associated vasculitis","SGLT-2 inhibitors","nephroprotection","2025-06-16",{"date":508,"type":38},"2025-06-25",{"date":484,"type":22},{"date":511,"type":22},"2026-12",{"name":513,"class":76},"Federico II University",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":522,"targetDuration":4,"studyType":23,"phases":524,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":77},"100592965","phase-1-msc303-subcutaneous-injection-for-the-treatment-of-immunologic-glomerular-disease-100592965","NCT07000292","MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.","A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics and Efficacy of Subcutaneous Injection of MSC303 for the Treatment of Immune Glomerular Diseases","MSC303","Inclusion Criteria:\n\n1. Aged 18 to 65 years (including boundary values), gender unspecified；\n2. Willing to participate voluntarily in this clinical study and with good compliance；\n3. Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:\n\n   1. Diagnosed with lupus nephritis(LN);\n   2. diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);\n4. Sufficient organ function;\n\nExclusion Criteria:\n\n1. History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；\n2. Active infection requiring antibiotic treatment；\n3. Concomitant with other serious diseases；\n4. Patients with congenital immunoglobulin deficiency；\n5. Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA ));\n6. Other exclusion criteria may apply.",{"count":523,"type":22},12,[25,59],"This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.",[28,527],"ANCA-Associated Glomerulonephritis",[520,529],"Immune glomerular diseases","2025-06-05",{"date":532,"type":38},"2025-06-11",{"date":534,"type":22},"2025-06-20",{"date":536,"type":22},"2027-02-20",{"name":538,"class":76},"Shanghai Changzheng Hospital",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":546,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":77},"100588633","phase-1-a-clinical-study-of-yts109-cell-in-rr-systemic-lupus-erythematosus-100588633","NCT06943937","A Clinical Study of YTS109 Cell in R\u002FR Systemic Lupus Erythematosus","An Exploratory Clinical Study of YTS109 Cell in Subjects With Refractory Disease Systemic Lupus Erythematosus","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Meet the EULAR\u002FACR 2019 SLE Classification Criteri:\n\nCohort 1: Refractory Lupus Nephritis: Defined as failure to achieve remission after treatment with corticosteroids and ≥2 immunosuppressants (e.g., CTX, tacrolimus, MMF, cyclosporine) and\u002For biologics, with urine protein\u002Fcreatinine ratio (UPCR ≥1.0 g\u002Fg) , and renal pathology requirement scriteria: ISN\u002FRPS 2003 Class III\u002FIV proliferative lupus nephritis (or combined with type V features) , with ≤50% glomerulosclerosis.\n\nCohort 2: Refractory Immune Thrombocytopenia: Requires treatment failure with: Failed treatment with at least 1 course of MP shock (1g for 3 days) or high- dose glucocorticosteroids (1mg\u002Fkg\u002Fd equivalent dose of glucocorticosteroids) in combination with 1 or more immunosuppressive agents. At least 2 consecutive routine blood tests for platelets less than 50×10\\^9\u002FL and \\>30×10\\^9\u002FL were performed prior to enrolment. other non-SLE causes of thrombocytopenia, such as infections, myelosuppression and hypersplenism, were excluded.\n\n3\\. Essential Organ Function Criteria:\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use).\n\n   Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL\n\n   ≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n5\\. Voluntary participation with signed informed consent and compliance.\n\nExclusions Criteria:\n\nSubjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Severe drug allergies or hypersensitivity.\n2. Uncontrolled\u002Funtreated infections (fungal, bacterial, viral, etc.).\n3. CNS disorders (exceptions: epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis).\n4. Heart failure intolerance.\n5. Congenital immunoglobulin deficiency.\n6. Malignancy within 5 years (exceptions: localized cancers with negligible metastasis risk).\n7. End-stage renal failure.\n8. Subjects positive for: HBsAg \u002F HBcAb with HBV DNA \\> detection limit; HCV Ab + HCV RNA; HIV Ab; Syphilis test.\n9. Deep vein thrombosis\u002Fpulmonary embolism within 6 months pre- screening.\n10. Severe mental illness\u002Fcognitive impairment.\n11. Participation in other clinical trials within 3 months pre-screening.\n12. Use of immunosuppressants (within 5 half-lives) or biologics (within 4 weeks) pre-screening.\n13. Pregnancy\u002Fbreastfeeding or planned conception.\n14. Other researcher-determined ineligibility.",{"count":547,"type":22},36,[25],"This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (1×10⁶-2×10⁶ cells\u002Fkg). The primary endpoint is observations of types, severity, and frequency of dose-limiting toxicities (DLTs) and adverse events (AEs). Secondary endpoints include the complete renal response (CRR) rate at week 12 in LN, and proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP. This single-arm, open-label trial will enroll patients across Beijing GoBroad Hospital in China.",[28,551],"Immune Thrombocytopenia (ITP)","2025-05-08",{"date":554,"type":38},"2025-05-13",{"date":556,"type":38},"2025-04-16",{"date":558,"type":22},"2027-04-25",{"name":258,"class":45},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":572,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":77},"100585475","equecabtagene-autoleucel-injection-eque-cel-for-relapsedrefractory-systemic-lupus-erythematosus-sle-100585475","NCT06902844","Equecabtagene Autoleucel Injection (Eque-cel) for Relapsed\u002FRefractory Systemic Lupus Erythematosus (SLE)","A Study of Equecabtagene Autoleucel Injection (Eque-cel) in the Treatment of Relapsed\u002FRefractory Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Age≥18 years old, male or female;\n2. Subjects with relapsed\u002Frefractory SLE:\n\n   1. Subjects must be diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria; the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥8, with a British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥1 organ at screening, or a BILAG-2004 activity score of B in ≥2 organs.\n   2. Subjects with lupus nephritis (LN) must be diagnosed with active, biopsy-confirmed lupus nephritis of type III, IV, or V, or type III\u002FIV combined with type V according to the 2018 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria; the SLEDAI-2000(SLEDAI-2K) score ≥8;\n   3. Regular treatment with glucocorticoids and at least two immunosuppressants，immunomodulators, antimalarials, or biologics for at least 3 months, but withpoorly-controlled symptoms or intolerance to treatment.\n3. Disease-related pathogenic antibody positive: anti-nuclear antibody (ANA) positive and\u002For anti-dsDNA positive and\u002For anti-Smith positive.\n4. After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year post Eque-cel infusion (excluding contraception safety periods).\n5. Subjects must provide written informed consent before the study begin.\n\nExclusion Criteria:\n\n1. Disease involved the nervous system with a BILAG-2004 activity score of Class A.\n2. History of solid organ transplantation.\n3. History of autologous or allogeneic stem cell transplantation.\n4. History of prior cell therapy or treatment of BCMA-targeted drug.\n5. Known history of primary immunodeficiency (innate or acquired). 6）Concomitant other autoimmune diseases that may interfere with the study evaluation.\n\n7\\) Subjects who have received the following drugs\u002Fnon-drug treatment:\n\n1. Subjects who have used therapeutic doses of corticosteroids (defined as \\>20 mg\u002Fday of prednisone or equivalent) within 1 week prior to enrollment. Corticosteroids must be tapered gradually according to clinical circumstances (e.g., duration and dose of treatment, severity of disease progression, and patient condition) before discontinuation，until reaching the allowable dose range specified in the protocol. Physiological replacement therapy, topical use, and inhaled corticosteroids are permitted.\n2. Subjects who have used immunosuppressants other than corticosteroids within 1 week prior to enrollment.\n3. Subjects who received biologic therapies or JAK\u002FBTK\u002FTYK inhibitors within 2 months prior to cell infusion, including but not limited to rituximab, belimumab, or baricitinib.\n4. Subjects who underwent plasmapheresis or double filtration within 1 week prior to enrollment.\n5. Subjects who received investigational drugs from another interventional clinical trial within 1 month before signing the informed consent form (ICF).\n6. Subjects who received treatment of the study disease with any unlisted drugs within at least 5 half-lives prior to cell infusion.\n\n   8)Major operation or surgical treatment caused by any reason that occurred or was planned within 4 weeks before enrollment or within 12 weeks after cell infusion.\n\n   9)History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.\n\n   10)Subjects have uncontrolled active fungal, viral, bacterial, or other infections (with persistent infection-related signs\u002Fsymptoms that have not improvedafter appropriate anti-infective therapy) or infections requiring intravenous anti-infective therapy.\n\n   11)Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with abnormal peripheral blood hepatitis B virus (HBV) DNA (defined as HBV DNA ≥100 IU\u002FmL or ≥1000 copies\u002FmL or above the normal reference range of the testing center, or positive qualitative HBV DNA); positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA (defined as ≥1000 IU\u002FmL); positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA (defined as ≥1000 IU\u002FmL); or positive for Treponema pallidum-specific antibody with positive rapid plasma reagin (RPR) test.\n\n   12)Blood tests: Absolute neutrophil count \\\u003C 1×10\\^9 \u002FL, or Absolute lymphocyte count \\\u003C 0.3×10 \\^ 9 \u002FL, or hemoglobin \\\u003C60 g\u002FL。 13)Subjects with serious cardiac disease: including but not limited to unstable angina and\u002For myocardial infarction within 12 months before screening, any congestive heart failure (New York Heart Association\\[NYHA\\] classification ≥Grade III), and a history of severe arrhythmias; or left ventricular ejection fraction (LVEF) \\\u003C45%.\n\n   14)Subjects with severe asthma or chronic obstructive pulmonary disease (COPD). Mild or moderate asthma or COPD under stable treatment may be considered with approval from the investigator and sponsor; orarterial oxygen saturation \\\u003C91% at rest.\n\n   15）Subjects have a significant risk of severe bleeding assessed by investigator.\n\n   16\\) Subjects have a severe hepatic insufficiency assessed by investigator. 17) History of severe renal disease; or an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m² calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.\n\n   18\\) History of acute cerebrovascular events, including transient ischemic attack or stroke, within 6 months prior to enrollment.\n\n   19\\) Any severe and\u002For uncontrolled comorbid conditions that, in the investigator's opinion, may interfere with the study evaluation.\n\n   20\\) Diagnosis of malignancy within 5 years prior to screening, except for cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ of the breast after radical surgery, or papillary thyroid carcinoma.\n\n   21\\) Known history of severe allergy to any component of the eque-cel injection. 22）Pregnant or lactating women. 23) Subjects with other conditions adjudicated by the investigator as unsuitable for enrollment.",{"count":568,"type":22},6,[121],"This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed \u002Frefractory systemic lupus erythematosus (SLE).",[33,28],[573,62,199],"CAR T","2025-03-24",{"date":576,"type":38},"2025-03-30",{"date":578,"type":22},"2025-04-05",{"date":580,"type":22},"2028-01-10",{"name":582,"class":76},"Tongji Hospital",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":591,"targetDuration":593,"studyType":336,"phases":4,"briefSummary":594,"conditions":595,"keywords":596,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":606,"locationsCount":77},"100566349","urinary-congophilia-as-an-indicator-of-activity-of-lupus-nephritis-100566349","NCT06654024","Urinary Congophilia as an Indicator of Activity of Lupus Nephritis","Assessment of Urinary Congophilia as an Indicator of Disease Activity of Lupus Nephritis","lupus nephriti","Inclusion Criteria:\n\n\\- Adult patients ≥ 18 years old that were diagnosed with SLE according to EULAR\u002FACR classification criteria 2019 for SLE, and lupus nephritis based on renal biopsy or active urinary sediment (proteinuria or hematuria )\n\nExclusion Criteria:\n\n* Any patient has evidence of nephritis that may cause proteinuria as diabetes mellitus and any other causes of glomerulonephritis other than lupus nephritis\n* pregnant females with lupus nephritis and hypertensive disorders",{"count":592,"type":22},74,"1 Month","Evaluation of the impact of SLE on urinary levels of congophilia and their relationship to renal histopathology and activity of lupus nephritis (LN)",[28],[597,598,599],"congophilia","lupus nephritis","congo red","2024-12-11",{"date":602,"type":38},"2024-12-16",{"date":604,"type":22},"2024-12",{"date":370,"type":22},{"name":488,"class":76},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":192,"maxAge":4,"enrollmentInfo":614,"targetDuration":616,"studyType":336,"phases":4,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":628,"locationsCount":77},"100568536","high-quality-evidence-of-guangzhou-lupus-nephritis-cohort-hope-cohort-100568536","NCT06682507","High Quality Evidence of Guangzhou Lupus Nephritis Cohort (HOPE Cohort)","HOPE","Inclusion Criteria:\n\nPatients who had biopsy proven lupus nephritis in The First Affiliated Hospital of Sun Yat-sen University\n\nExclusion Criteria:\n\n* less than 14 years old\n* refused to give written consent",{"count":615,"type":22},5000,"30 Years","The goal of this observational study is to learn about the long-term renal and patient's survival of lupus nephritis (LN) patients in China. The main question it aims to answer is:\n\nDoes the renal and patient's survival improved in the long term period? Participants who had renal biopsy proven lupus nephritis in one hospital will be followed up.",[28],[341,598,620,621],"outcomes","end stage kidney disease","2024-11-08",{"date":624,"type":38},"2024-11-12",{"date":626,"type":38},"1996-01-01",{"date":349,"type":22},{"name":629,"class":76},"First Affiliated Hospital, Sun Yat-Sen University"]