[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lupus-nephritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lupus-nephritis":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,64,0,25,[9,44,72,100,127,157,179,214,255,278,303,329,359,387,416,443,469,492,513,544,573,597,627,661,685],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640944","phase-2-a-study-to-evaluate-mosunetuzumab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640944",false,"NCT07598396","A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","SOLUNA","Inclusion Criteria:\n\n* Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria at screening\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* Any major episode of infection as defined by the protocol\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* Tuberculosis (TB) infection\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex\n* History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1\n* History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years\n* Receipt of any live or attenuated vaccine in the 28 days prior to or during screening","ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).",[28,29,30],"Lupus","Systemic Lupus Erythematosus","Lupus Nephritis","RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-05-25",{"date":39,"type":22},"2028-08-31",{"name":41,"class":42},"Hoffmann-La Roche","INDUSTRY",21,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100652816","sii-and-siri-as-prognostic-biomarkers-in-lupus-nephritis-100652816","NCT07780045","SII and SIRI as Prognostic Biomarkers in Lupus Nephritis","Emerging Inflammatory Biomarkers (SII and SIRI) for Predicting Disease Activity, Renal Flares and Outcomes in Lupus Nephritis: A Prospective Observational Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of systemic lupus erythematosus according to the 2019 EULAR\u002FACR classification criteria\n* Confirmed lupus nephritis according to ISN\u002FRPS classification\n\nExclusion Criteria:\n\n* Active infection, sepsis, or other concurrent inflammatory or autoimmune conditions\n* Malignancy or hematologic disorders affecting blood cell counts\n* Pregnancy\n* Use of medications significantly affecting blood counts (such as recent chemotherapy or G-CSF)\n* Incomplete medical records or anticipated loss to follow-up","70 Years",{"count":53,"type":22},100,"12 Months","OBSERVATIONAL","This prospective observational study aims to evaluate the prognostic utility of the Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) as novel inflammatory biomarkers for monitoring disease activity and predicting renal progression, flares, and outcomes in patients with lupus nephritis.",[30,29,58],"Kidney Diseases",[60,61,62],"Systemic Immune-Inflammation Index SII","Systemic Inflammation Response Index SIRI","Lupus Nephritis Biomarkers","NOT_YET_RECRUITING","2026-08-19",{"date":34,"type":35},{"date":64,"type":22},{"date":68,"type":22},"2027-10-19",{"name":70,"class":71},"Assiut University","OTHER",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":76,"conditions":84,"keywords":85,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100525404","phase-1-reset-sle-a-phase-12-open-label-study-to-evaluate-the-safety-and-efficacy-of-caba-201-in-subjects-with-active-systemic-lupus-erythematosus-100525404","NCT06121297","RESET-SLE: A Phase 1\u002F2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus","A Phase 1\u002F2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Age ≥18 and ≤65\n* A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for adult SLE.\n* Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening.\n* For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria\n* For non-renal SLE subjects only: Active, moderate to severe SLE\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* For LN subjects only: The presence of kidney disease other than active lupus nephritis\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.","65 Years",{"count":81,"type":22},28,[83,25],"PHASE1",[29,30],[86,87,88,89,29,30],"CABA-201","Autoimmune Disease","Anti-CD19 CAR-T therapy","Cellular Therapy","2026-08-17",{"date":92,"type":35},"2026-08-18",{"date":94,"type":35},"2024-02-16",{"date":96,"type":22},"2029-12",{"name":98,"class":42},"Cabaletta Bio",23,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100337461","phase-2-treatment-of-lupus-nephritis-with-allogeneic-mesenchymal-stem-cells-100337461","NCT03673748","Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells","Phase II, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate Safety and Efficacy of Mesenchymal Stem Cells (MSV-allo) in the Treatment of Lupus Nephritis","MSV_LE","INCLUSION CRITERIA:\n\n1. Females or males ≥18 years old who provide written informed consent at the selection visit.\n2. Diagnosis of systemic lupus erythematosus (SLE) by meeting at least 4 of the 11 criteria included in the American College of Rheumatology (ACR) classification and\u002For the Systemic Lupus International Collaborating Clinics (SLICC) criteria, at the selection visit.\n3. Diagnosis of lupus nephritis (LN) using the 2003 classification of the International Society of Nephrology and the Society of Renal Pathology, by biopsy performed no more than 6 months before the selection visit if they enter from the induction period, and no more than one year if they enter with a moderate\u002Fsevere recurrence.\n4. No response or partial response to standard treatment, or moderate\u002Fsevere recurrence of lupus nephritis.\n5. SLEDAI-2K ≥ 10 during the selection period.\n6. Women of childbearing potential should use effective methods of contraception to prevent pregnancy.\n7. Have been vaccinated against pneumococcus and influenza at the time the vaccination campaign is carried out.\n\nEXCLUSION CRITERIA:\n\nA - Related to previous treatments:\n\n1. Use of corticosteroids or mycophenolate above the doses allowed for induction, according to the Consensus Document of the Systemic Autoimmune Diseases Group of the Spanish Society of Internal Medicine and the Spanish Society of Nephrology.\n2. Use of rituximab, belimumab, ocrelizumab or other biologic therapies against B cells in the 6 months prior to selection.\n3. Use of cyclophosphamide in the 6 months prior to selection.\n4. Use of any tumor necrosis factor inhibitor treatment in the 6 months prior to selection.\n5. Use of immunoglobulins in the 6 months prior to selection.\n6. Change in doses of an angiotensin converting enzyme inhibitor or an angiotensin receptor inhibitor in the two months prior to selection.\n7. Treatment with another investigational medicinal product within three months prior to selection or 5 times the half-life of the agent.\n\n   B - Related to medical problems:\n8. Any pathology, including an uncontrolled disease other than SLE, which, in the opinion of the investigator, the sponsor or the person they designate, constitutes an inappropriate risk or a contraindication for participation in the trial or that could interfere with the objectives of the trial, its performance or evaluation.\n9. Cardiac, peripheral, or cerebrovascular cardiovascular events in the 6 months prior to the selection visit.\n10. Active cardiac arrhythmia or clinically significant electrocardiogram abnormalities at selection visit or on the day of randomization that, in the opinion of the investigator, sponsor, or designee, constitute an inappropriate risk or contraindication to participation in the study.\n11. Thromboembolic events in the 12 months prior to or during selection, whether or not associated with associated antiphospholipid syndrome, or inadequate anticoagulation tests 6 weeks immediately prior to or during selection visit.\n12. Active central nervous system SLE that is considered severe or progressive (recent uncontrolled seizures, changes in anticonvulsant treatment within 3 months prior to selection visit, or resulting in significant cognitive impairment).\n13. History or current diagnosis of a demyelinating disease such as multiple sclerosis or optic neuritis.\n14. Comorbidities that require treatment with systemic corticosteroids (oral, rectal or injectable) such as asthma or inflammatory bowel disease.\n15. Antecedents or plans for an organ transplant.\n16. Clinically significant active viral, bacterial or fungal infection, or having suffered a major episode of infection that required hospitalization or parenteral treatment in the 4 weeks prior to the selection visit, during the selection visit, or having finished anti-infective treatment within 2 weeks prior to or during selection, or a history of recurrent infections (three or more cases of the same type of infection in a consecutive 12-month period). Controlled vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus would not be reasons for exclusion.\n17. History of or positive human immunodeficiency virus (HIV) test result, hepatitis C antibodies and\u002For detection by polymerase chain reaction, hepatitis B surface antigen (HBsAg+), and\u002For IgM or total antibodies against hepatitis B nuclear antigen at selection.\n18. Diagnosis of active or latent tuberculosis (TB) using a purified protein derivative TB skin test (induration ≥ 5 mm) or a positive Quantiferon test result, at selection or within 3 months prior to the selection visit. Patients who have completed previous adequate treatment or who are receiving treatment will not repeat the test. Patients who are receiving adequate TB treatment for at least 4 continuous weeks prior to the selection visit and who are expected to complete the treatment regimen will not be excluded.\n19. Presence of class 3 or 4 uncontrolled congestive heart failure according to the New York Heart Association.\n20. Active cancer.\n21. Major surgical intervention within 6 weeks prior to selection visit or planned during the trial period, including follow-up.\n22. Pregnant or lactating women.\n\n    C - Laboratory abnormalities:\n23. Clinically significant laboratory test abnormalities not attributed to active SLE.\n24. Chest X-ray with significant changes indicating active TB. The chest X-ray must have been performed within 3 months prior to the selection visit or during the selection period.\n\n    D - Others:\n25. Legal incapacity.",{"count":109,"type":22},20,[25],"The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis. The objective of this study is to evaluate the efficacy of mesenchymal stem cells (MSCs) in achieving a full or partial response in the treatment of Lupus Nephritis (LN) during its induction period.",[30,113],"Lupus Erythematosus",[113,30,115,116,117,29],"Stem Cell","Mesenchymal Stem Cells","Autoimmune diseases","2026-08-14",{"date":92,"type":35},{"date":121,"type":35},"2022-12-27",{"date":123,"type":22},"2028-12",{"name":125,"class":42},"Red de Terapia Celular",1,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":18,"minAge":135,"maxAge":51,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100636836","phase-2-a-phase-2-open-label-single-arm-trial-of-ft819-in-participants-with-lupus-nephritis-100636836","NCT07570862","A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis","A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)","RECLAIM-LN","INCLUSION CRITERIA:\n\n* Age ≥12 to ≤70 years\n* Diagnosis of SLE per EULAR\u002FACR 2019 classification criteria\n* Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003\u002F2018 ISN\u002FRPS classification\n* Positivity for at least one of the following autoantibodies at screening:\n\n  1. Antinuclear antibody (ANA)\n  2. Anti-double-stranded DNA (anti-dsDNA) or\n  3. Anti-Smith antibody\n* Active disease, defined as:\n\n  a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g\u002Fg; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible\n* Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN\n\nEXCLUSION CRITERIA:\n\n* Evidence of inadequate organ function during the screening period\n* Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention\n* History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity\n* Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention\n* Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant\n* History of malignancy in the prior 5 years\n* Known allergy to the following FT819 components: albumin (human) or DMSO\n* History of intolerance or contraindication to bendamustine\n* Body weight \\\u003C30 kg\n* Any medical condition, clinical laboratory abnormality, or nonmedical\u002Fsocial issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results","12 Years",{"count":137,"type":22},53,[25],"The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.",[30,29,141,142,143],"SLE - Systemic Lupus Erythematosus","Lupus Nephritis - WHO Class III","Lupus Nephritis - WHO Class IV",[145,146,147,148,30,29],"FT819","Fate Therapeutics","Allogeneic CAR T","CD19 - targeted therapy","2026-08-13",{"date":90,"type":35},{"date":152,"type":35},"2026-07-27",{"date":154,"type":22},"2030-01-31",{"name":146,"class":42},6,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":79,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100651932","phase-3-a-prospective-multicenter-trial-to-explore-the-efficacy-and-safety-of-obinutuzumab-adds-on-to-standard-of-care-therapy-consisting-of-mycophenolate-mofetil-mmf-and-corticosteroids-o-triple-as-initial-therapy-in-the-active-lupus-nephritis-patients-100651932","NCT07767188","A Prospective, Multicenter Trial to Explore the Efficacy and Safety of Obinutuzumab Adds on to Standard-of-care Therapy Consisting of Mycophenolate Mofetil (MMF) and Corticosteroids (O-triple) as Initial Therapy in the Active Lupus Nephritis Patients","A Prospective, Multicenter Trial to Explore the Efficacy and Safety of Obinutuzumab Adds on to Standard-of-care Therapy Consisting of Mycophenolate Mofetil (MMF) and Corticosteroids (O-triple) as Initial Therapy in the Active Lupus Nephritis Patients (INITIAL Trial)","INCLUSION CRITERIA：\n\n1. Signed Informed Consent Form\n2. Age 18 to 65 years at time of signing Informed Consent Form\n3. Ability to comply with the study protocol, in the investigator's judgment\n4. ISN\u002FRPS 2003 Class III, IV, V active\u002Factive chronic LN by renal biopsy performed within the 1 month prior to screening or during screening with 24hUPCR≥1g\u002Fg\n5. SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria, which are met by the presence of Class III- V LN or mixed Class LN, and current or past positive antinuclear antibody (ANA) Positive ANA is defined by ANA at a titer of ≥ 1:80 on HEp-2 cells or an equivalent positive ANA test at least once.\n6. Receipt of at least one dose of pulse methylprednisolone IV (≥250 mg) or equivalent for treatment of the current episode of active LN during the 1 month prior to screening or during screening\n7. A maximum of 3 g methylprednisolone IV or equivalent d during the 4 weeks prior to screening or during screening is allowed.\n\nEXCLUSION CRITERIA：\n\n1. Are pregnant or breastfeeding.\n2. Have severe renal impairment, defined as eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² (estimated using the CKD-EPI equation), or require dialysis or renal transplantation.\n3. Have renal biopsy showing \\> 50% glomerular sclerosis.\n4. Have pure chronic renal biopsy findings: no active lesions.\n5. Have rapidly progressive glomerulonephritis.\n6. Have active gastrointestinal ulcer.\n7. Have intolerance or contraindication to the study treatment.",{"count":165,"type":22},70,[167],"PHASE3","This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patients",[30],"2026-08-11",{"date":90,"type":35},{"date":173,"type":22},"2026-09-10",{"date":175,"type":22},"2029-05-08",{"name":177,"class":71},"Zhao Minghui",14,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":187,"sex":18,"minAge":188,"maxAge":51,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":126},"100651326","phase-4-assessing-residual-inflammation-and-macrophage-presence-in-lupus-nephritis-after-3-months-of-intensified-treatment-with-prednisolone-mycofenolate-mofetil-and-voclosporin-as-compared-to-mycofenolate-mofetil-and-prednisolone-100651326","NCT07760480","Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone","Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone, an Open Label Randomized Controlled Trial","MAPLE","Lupus nephritis patients\n\nInclusion Criteria:\n\n* Patients with de novo or flaring SLE according to the EULAR\u002FACR criteria and a suspicion of class III or IV LN with a clinical indication to perform a kidney biopsy\n* Age 16-70 years\n* eGFR as measured by cystatin C \\>20 mL\u002Fmin\n\nExclusion Criteria:\n\n* LN class I, II or pure class V upon kidney biopsy\n* eGFR as measured by cystatin C \\\u003C20 mL\u002Fmin\n* Histological chronicity score (NIH) of 8 or higher in the kidney biopsy\n* Active infection of any kind as evidenced by cultures (blood, urine or otherwise)\n* History of hepatitis B, hepatitis C, tuberculosis and\u002For HIV\n* Treatment with any of the following agents within one month before screening:\n\ntacrolimus, belimumab, anifrolumab - Treatment with any of the following agents within 6 months before screening: rituximab, daratumumab, eculizumab\n\n* Prolongation of QT-interval (QTc \\>470ms) and\u002For bradycardia (resting heart rate \\\u003C50bpm) measured on two separate occasions\n* Hyperkalaemia (serum potassium \\>6.0 mmol\u002FL)\n* Hypertension (blood pressure \\> 165\u002F105 mmHg, with symptoms of hyperten sion)\\*\n* Co-administration of voclosporin with strong CYP3A4 inhibitors (e.g., ke toconazole, itraconazole, clarithromycin)\n* Pregnancy\n\n  * A single elevated blood pressure measurement will not lead to immediate exclusion from the trial. Antihypertensive therapy may be initiated as appropriate. Dose adjustments of voclosporin should be made in accordance with Section 11.3.2 of the protocol\n\nSLE patients without LN (disease control group) Inclusion criteria\n\n* Diagnosis of SLE according to EULAR\u002FACR guidelines\n* Age 16-70\n\nExclusion criteria\n\n* Suspicion of LN\n* Signs of active infection\n\nHealthy subjects (control group) Inclusion criteria\n\n* Blank medical history\n* Age 16-70\n* A majority (75%) of female healthy subjects will be sought\n\nExclusion criteria\n\n\\- Signs of active infection",true,"16 Years",{"count":190,"type":22},55,[192],"PHASE4","The goal of this clinical trial is to learn how different treatments affect immune cells in the kidney in people with active lupus nephritis (LN), a kidney manifestation of systemic lupus erythematosus (SLE). It will also investigate whether early changes in kidney tissue can predict long-term treatment response and whether blood or urine biomarkers can be used to monitor disease activity without the need for repeat kidney biopsies.\n\nThe main questions it aims to answer are:\n\n* Does adding voclosporin to standard treatment with mycophenolate mofetil (MMF) and prednisolone result in greater early improvement of kidney inflammation compared with MMF and prednisolone alone?\n* Are specific macrophage and monocyte populations associated with treatment response and long-term kidney outcomes?\n* Can blood- or urine-based biomarkers be identified that reflect kidney inflammation and treatment response?\n\nResearchers will compare MMF, prednisolone, and voclosporin (triple therapy) with MMF and prednisolone alone (dual therapy) to determine whether intensified treatment leads to faster and more complete immunological and histological remission.\n\nParticipants with newly diagnosed or relapsing proliferative lupus nephritis will:\n\n* Be randomly assigned to receive either triple therapy (MMF, prednisolone, and voclosporin) or dual therapy (MMF and prednisolone).\n* Undergo a kidney biopsy before treatment starts and a repeat kidney biopsy after 3 months of treatment.\n* Provide blood and urine samples during follow-up for immune cell analyses and biomarker studies.\n* Complete patient-reported outcomes questionnaires\n* Attend regular study visits and clinical assessments for up to 2 years.\n\nIn addition, participants with SLE without lupus nephritis and healthy volunteers will provide blood samples to allow comparison of circulating immune cell populations between groups.",[30,195],"Systemic Lupus Erythematosus (SLE)",[30,197,198,199,200,201,202,203,204],"LN","SLE","Systemic lupus erythematosus","volcosporin","mmf","cellcept","prednisolone","kidney biopsy","2026-08-10",{"date":207,"type":35},"2026-08-12",{"date":209,"type":35},"2026-04-23",{"date":211,"type":22},"2030-04",{"name":213,"class":71},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":232,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":178},"100587219","phase-1-a-safety-and-efficacy-study-evaluating-ctx112-in-adult-subjects-with-refractory-autoimmune-disease-100587219","NCT06925542","A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease","A Phase 1 Dose Evaluation Study of the Safety and Preliminary Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Subjects With Refractory Autoimmune Disease","Key Inclusion Criteria:\n\n1. Age ≥18 years and \\\u003C 70 years of age.\n2. Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements.\n3. Adequate hematologic, renal, liver, cardiac and pulmonary organ function.\n4. Subjects must agree to use acceptable methods of contraception.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.\n6. Diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc) or idiopathic inflammatory myopathy (IIM).\n\nFor systemic lupus erythematosus (SLE) subjects:\n\n\\- Diagnosis of SLE by a board-certified rheumatologist that conforms with 2019 ACR\u002FEULAR criteria. For lupus nephritis subjects, active, biopsy-proven proliferative lupus nephritis Class III or IV, either with or without the presence of Class V, and appropriate National Institutes of Health index activity score using the 2018 International Society of Nephrology\u002FRenal Pathology Society criteria.\n\nFor Systemic Sclerosis (SSc) subjects:\n\n\\- Diagnosis of diffuse cutaneous systemic sclerosis (dcSSC) or SSc-ILD that conforms with 2013 ACR\u002FEULAR criteria. Subjects should meet active skin or lung disease criteria.\n\nFor Idiopathic Inflammatory Myopathy (IIM) subjects:\n\n\\- Diagnosis with dermatomyositis (DM), polymyositis (PM) or myositis as part of rheumatologic overlap syndrome, antisynthetase (ASyS), or immune-mediated necrotizing myopathy (IMNM) that conforms with 2017 ACR\u002FEULAR criteria for inflammatory myopathies. Subjects must meet moderate severe, skin, or lung involvement criteria.\n\nKey Exclusion Criteria:\n\n1. Prior anti-CD19 therapy or any gene therapy\u002Fgenetically modified cell therapy.\n2. Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.\n3. Severe active or history of central nervous (CNS) involvement.\n4. History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement other than SLE, SSc or IIM.\n5. Mixed connective tissue disease with no clear predominant disease.\n6. Presence of study disease manifestations or other conditions that are likely to pose increase safety risks and\u002For confound disease assessments, or pose significant risk to those receiving CAR T cell therapy.\n7. History of primary or secondary immunodeficiency.\n8. Presence or history of certain bacterial, viral or fungal infection.\n9. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence).\n10. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome.\n11. History or current diagnosis of catastrophic anti-phospholipid syndrome or anti phospholipid syndrome that requires ongoing anticoagulation.\n12. Pregnant or lactating.\n13. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol.",{"count":222,"type":22},80,[83],"This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).",[226,227,30,228,229,230,231],"SLE (Systemic Lupus)","Lupus Erythematosus, Systemic","Systemic Sclerosis","Inflammatory Myopathy, Idiopathic","Myositis","Diffuse Cutaneous Systemic Sclerosis",[233,28,198,30,234,235,236,237,230,238,239,240,241,242,243,244,245],"CAR T","Allogeneic","CD19","Cell Therapy","Scleroderma","Systemic sclerosis","Idiopathic Inflammatory Myopathy","Inflammatory Myopathy","Diffused Cutaneous Systemic Sclerosis","Gene Therapy","Autoimmune","SSc","IIM","2026-08-05",{"date":248,"type":35},"2026-08-07",{"date":250,"type":35},"2025-03-10",{"date":252,"type":22},"2031-12-31",{"name":254,"class":42},"CRISPR Therapeutics",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":263,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100442302","phase-2-a-study-to-evaluate-the-efficacy-safety-and-pharmacokinetics-of-obinutuzumab-in-adolescents-with-active-class-iii-or-iv-lupus-nephritis-and-the-safety-and-pk-of-obinutuzumab-in-pediatric-participants-100442302","NCT05039619","A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants","A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to \u003C 12)","POSTERITY","Inclusion Criteria:\n\n* Participants who are age 12 to \\\u003C18 years at the time of randomization\n* Participants who are age 5 to \\\u003C12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)\n* International Society of Nephrology and the Renal Pathology Society (ISN\u002FRPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening\n* Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible\n* Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria\n* Significant proteinuria defined by a UPCR above \\> 0.5 based on a first-morning void (FMV) collection at screening\n* During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg\u002Fkg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.\n\nExclusion Criteria:\n\n* Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia\n* Sclerosis in \\>50% of glomeruli on renal biopsy\n* Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions\n* Presence of rapidly progressive glomerulonephritis\n* Pure Class V LN\n* Intolerance or contraindication to study therapies\n* Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization\n* History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders\n* History of serious recurrent or chronic infection\n* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years\n* Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation\n* Currently active alcohol or drug abuse or history of alcohol or drug abuse","5 Years","17 Years",{"count":266,"type":22},40,[25],"This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \\\u003C12 with LN.",[30],"2026-08-03",{"date":246,"type":35},{"date":273,"type":35},"2022-05-12",{"date":275,"type":22},"2030-06-14",{"name":41,"class":42},43,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100643458","phase-4-preserve-lupkynis-in-combination-with-belimumab-obinutuzumab-or-anifrolumab-in-patients-with-lupus-nephritis-100643458","NCT07611214","PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis","PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis","Key Inclusion Criteria:\n\n* Adults 18-75 years old\n* Diagnosed with biopsy-proven lupus nephritis (LN) according to the 2003 International Society of Nephrology (ISN) \u002F Renal Pathology Society (RPS) (class III, class IV, class III\u002FV or class IV\u002FV)\n* Urine protein-to-creatine ratio (UPCR) ≥0.5 g\u002Fg and \\\u003C5.0 g\u002Fg from a first morning void (FMV) urine sample\n* Estimated glomerular filtration rate (eGFR) of ≥45 mL\u002Fmin\u002F1.73 m2\n* Concomitant biologic:\n\n  * Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will initiate belimumab or anifrolumab (as applicable) on or before Day 1.\n  * Patients on the obinutuzumab treatment regimen must have received at least 2 administrations of obinutuzumab prior to Screening.\n* Willing to take mycophenolic acid analog (MPAA), either by continuing current MPAA therapy or by initiating it on or before Day 1\n* Willing to take corticosteroids, either by continuing current corticosteroids (prednisone \\[or equivalent\\]) or by initiating on or before Day 1\n\nKey Exclusion Criteria:\n\n* Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration of B cell count within the normal range\n* Cyclophosphamide or any calcineurin inhibitor other than voclosporin (eg, cyclosporine and tacrolimus) within 3 months prior to Screening\n* Any other immunosuppressive therapy except for the concomitant drugs (anifrolumab, MPAAs and oral prednisone \\[or equivalent\\]) and immunosuppressive agents used to treat a patient's underlying systemic lupus erythematosus (SLE), including, but not limited to, the examples below, within 30 days or 5 half-lives, whichever is longer, prior to Screening:\n\n  * Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab)\n  * Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab)\n  * T cell costimulation modulator (eg, abatacept)\n  * Intravenous immunoglobulin (IVIg)\n  * Janus kinase (JAK) inhibitors (eg, upadacitinib)\n* Pregnant, breastfeeding or intending to become pregnant during the Study","75 Years",{"count":287,"type":22},150,[192],"The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).",[30],[292,293],"voclosporin","calcineurin inhibitor","2026-07-31",{"date":270,"type":35},{"date":297,"type":35},"2026-04-22",{"date":299,"type":22},"2029-03-02",{"name":301,"class":42},"Aurinia Pharmaceuticals Inc.",27,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":135,"maxAge":79,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":178},"100597077","phase-2-obe-cel-in-severe-refractory-systemic-lupus-erythematosus-sle-with-active-lupus-nephritis-ln-100597077","NCT07053800","Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)","A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis","LUMINA","Inclusion Criteria:\n\n* Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative\n* Ability and willingness to adhere to protocol's Schedule of Activities and other requirements\n* Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent.\n* Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding\n* Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus.\n* Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.\n* Severe, Active SLE defined as:\n\n  * SLEDAI-2K score of ≥ 8 points AND\n  * Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)\n* Refractory SLE defined as failure to previous lines of therapy\n\nExclusion Criteria:\n\n* Prior treatment at any time with anti-CD19 therapy\n* More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and\u002For makes the immunosuppressive washout impossible\n* Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant\n* History of primary antiphospholipid antibody syndrome\n* Active or uncontrolled fungal, bacterial, or viral infection\n* History of malignant neoplasms unless disease free for at least 24 months\n* History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant",{"count":312,"type":22},35,[25],"The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).",[30],[199,317,318,319,320],"Refractory systemic lupus erythematosus","Lupus nephritis","Obecabtagene autoleucel","Obe-cel","2026-07-30",{"date":294,"type":35},{"date":324,"type":35},"2026-01-16",{"date":326,"type":22},"2029-10",{"name":328,"class":42},"Autolus Limited",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100459874","phase-2-study-of-efficacy-and-safety-of-lnp023-in-participants-with-active-lupus-nephritis-class-iii-iv---v-100459874","NCT05268289","Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +\u002F- V","An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +\u002F- V","Inclusion Criteria:\n\nUnequivocally positive ANA test result and\u002For a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis.\n\nDocumentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF\u002FMPS.\n\neGFR ≥ 30 ml\u002Fmin\u002F1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study.\n\nFirst presentation or flare of lupus nephritis.\n\nExclusion Criteria:\n\nInduction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization.\n\nPresence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening.\n\nRenal biopsy presenting with interstitial fibrosis\u002Ftubular atrophy (IF\u002FTA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy.\n\nParticipants being treated with systemic corticosteroids (\\>5 mg\u002Fday prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease.\n\nParticipants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg\u002Fday prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg\u002Fday in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment)\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","100 Years",{"count":338,"type":22},240,[25],"The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.",[30],[343,344,30,345,346,347,348,349,29],"LNP023","Iptacopan","proteinuria","Urine Protein-to-Creatinine Ratio","complete renal response","estimated glomerular filtration rate","renal flares","2026-07-29",{"date":321,"type":35},{"date":353,"type":35},"2022-08-10",{"date":355,"type":22},"2028-09-28",{"name":357,"class":42},"Novartis Pharmaceuticals",103,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":187,"sex":366,"minAge":19,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":126},"100532768","wellness--workforce-solution-for-lupuslupus-nephritis-100532768","NCT06217107","Wellness & Workforce Solution for Lupus\u002FLupus Nephritis","[2069264-1] Wellness & Workforce Solution for Lupus and Lupus Nephritis \u002F Janssen Clinical Investigator Initiated Study","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. females ; Age over 18yo\n4. Self-reported diagnosis of Lupus or Lupus Nephritis, or documented diagnosis of Lupus or Lupus Nephritis\n5. Willingness to adhere to the study intervention regimen\n6. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart-phone, internet access)\n7. Not currently practicing self-management behaviors and have not participated in a class or program on self-management behavior within the last 12 months\n\nAdult women with lupus and lupus nephritis will be enrolled in the study. Eligibility: Adult women with lupus and lupus nephritis who are able to consent and participate in self-management support training. Access to the internet is required for this intervention. Ability to read English is required because all the materials are currently in English.\n\nCoaches must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for duration of study\n3. Women of color with lupus or lupus nephritis with desire to help others\n4. Ability to communicate in English\n5. Secure access to Internet\n6. Private space for conducting participant visits\n7. Ability to use internet-based platform\n\nExclusion Criteria:\n\n-Potential participants and coaches who are unable to speak or read English, access the internet, or complete data collection activities will be ineligible for participation.","FEMALE",{"count":368,"type":22},160,[370],"NA","The investigators will test the hypothesis that culturally congruent coaching delivered via a technology application (Health360x) will improve the persistent disparities observed among women of color with lupus or lupus nephritis by addressing underlying psychosocial barriers to behavioral change.",[30],[28,30,374,375,376,377],"Health360x","Behavioral Intervention","Health coach","Health Literacy","2026-07-22",{"date":380,"type":35},"2026-07-24",{"date":382,"type":35},"2024-09-14",{"date":384,"type":22},"2026-12-31",{"name":386,"class":71},"Morehouse School of Medicine",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":285,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":126},"100648493","phase-2-obinutuzumab-for-systemic-lupus-erythematosus-pure-membranous-nephropathy-a-phase-ii-trial-100648493","NCT07721363","Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial","Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial (OBLUMEN)","OBLUMEN","Inclusion Criteria:\n\n1. Diagnosis of SLE fulfilling the 2019 EULAR\u002FACR classification criteria (score \\> 10)\n2. Age from 18 to 75 years old included\n3. Pure class V lupus nephritis, defined on a renal biopsy sample following the ISN\u002FRPS 2003 criteria AND\n\n   * Nephrotic range proteinuria (UPCr or UACr \\> 3 g\u002Fg) at screening visit OR\n   * Uncontrolled proteinuria after at least 3 months of well-conducted anti-proteinuric therapy \\[UPCR\\> 1 g\u002Fg despite maximal or maximally tolerated dose of ACEi or ARB + SGLT2i therapy +\u002F- diuretic therapy\\] and up to 12 months after pure class V lupus nephritis diagnosis.\n4. For women of childbearing age, agreement to remain abstinent (refrain from heterosexual intercourse) or willingness to use appropriate and effective contraception, as recommended when using obinutuzumab (18 months after last infusion)\n5. Signature of informed consent\n6. French social security affiliation (beneficiary or legal)\n7. Time interval between kidney biopsy showing pure class V LN and baseline visit of no more than 12 months\n\nExclusion Criteria:\n\n1. Ongoing treatment (induction or maintenance) for proliferative LN (class III-A or IV-A)\n2. Negativity for anti-nuclear antibodies (\\\u003C 1\u002F80) on immunofluorescence assay\n3. Severe extra-renal (i.e but not limited to : cardiac, central nervous system, pulmonary, enteric) lupus flare requiring high dose (\\> 1 mg\u002Fkg\u002Fday) corticosteroids.\n4. Receipt of any of the following excluded therapies:\n\n   * Any anti-CD20 therapy such as rituximab, ocrelizumab, or ofatumumab less than 6 months prior to screening or during screening. If an anti-CD20 therapy has been received between 6 and 12 months prior to screening, the peripheral CD19+ B-cell count by flow cytometry must be \\> 25 cells\u002FµL\n   * Cyclophosphamide, tacrolimus, ciclosporin, mycophenolate mofetil, pulse methylprednisolone or voclosporin during the 2 months prior to screening or during screening. Patients maintained on low-dose corticosteroids (\\\u003C10 mg\u002Fday prednisone equivalent) for a prolonged period as part of the management of a previous and resolved flare are eligible for trial participation.\n   * Any biologic therapy (other than anti-CD20) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening\n   * Oral inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening\n   * Any live vaccine during the 28 days prior to screening or during screening\n5. Contraindication to the use of obinutuzumab, its premedication drugs or hypersensitivity to its excipients.\n6. Fewer than 10 non-sclerosed glomeruli analyzable on renal biopsy\n7. Ongoing pregnancy or breastfeeding women\n8. CKD stage 4 or 5, defined as eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 according to CKD-EPI creatinine equation measured two times in an interval of 3 months (to be dissociated from acute kidney injury).\n9. Obsolescence of more than 60% of glomeruli or tubulo-interstitial scarring of more than 60% on kidney biopsy.\n10. Patients already included in an interventional study (RIPH1, clinical investigation or clinical trial)\n11. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom\n12. Patients with a previously documented kidney disease causing proteinuria (\\> 3 g\u002Fg or \\> 3 g\u002Fday) more than 1 year prior to the diagnosis of pure class V LN.\n13. Exclusion of primary membranous nephropathy, defined by positive anti-PLA2R antibodies on serum and\u002For glomerular PLA2R staining on kidney biopsy",{"count":396,"type":22},65,[25],"Lupus nephritis (LN) is a frequent and severe complication of systemic lupus erythematosus, with important mortality and morbidity. International 2024 guidelines recommend immunosuppressive therapy (MMF, cyclophosphamide, calcineurin inhibitors, rituximab, azathioprine) in patients with heavy or uncontrolled proteinuria, but none of these therapies has been evaluated in robust multicenter prospective. Therefore, no treatment has regulatory approval for pure class V LN.\n\nObinutuzumab, a 2nd-generation B-cell targeting therapy, is more efficient than rituximab in inducing B-cell depletion and complete renal response in patient with class III or IV lupus nephritis.\n\nThis study aims to assess the efficacy and safety of an obinutuzumab monotherapy in patients with pure class V LN. The primary endpoint is complete renal response at week 52 according to 2024 KDIGO criteria (UPCR \\\u003C 0.5 g\u002Fg, eGFR ≥ 85% of baseline, and no intercurrent event: treatment failure, rescue therapy, long-term dialysis, renal transplantation, death or early trial withdrawal)",[30,400],"Membranous Nephropathy",[402,403,199,404,405,406],"Class V lupus nephritis","Pure lupus membranous nephropathy","Membranous nephropathy","Obinutuzumab","B-cell targeted therapy","2026-07-20",{"date":409,"type":35},"2026-07-23",{"date":411,"type":22},"2026-09-02",{"date":413,"type":22},"2029-09-02",{"name":415,"class":71},"Assistance Publique - Hôpitaux de Paris",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":336,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":429,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},"100570795","phase-3-phase-iii-extension-study-of-efficacy-and-safety-of-ianalumab-with-or-without-study-treatment-withdrawal-in-participants-with-lupus-nephritis-sirius-ln-extension-100570795","NCT06711887","Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)","An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)","SIRIUS-LN ext","Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the extension study.\n2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.\n\nExclusion Criteria:\n\n1. Use of prohibited therapies\n2. Pregnant or nursing (lactating) women.",{"count":425,"type":22},348,[167],"The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety\n\n1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on double-blind treatment at the end of the SIRIUS-LN core study, and\n2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR\u002FPRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.",[30],[430,431,432,433],"Lupus Nephritis (LN)","B cell depletion","ianalumab","VAY736","2026-07-08",{"date":436,"type":35},"2026-07-10",{"date":438,"type":35},"2025-05-19",{"date":440,"type":22},"2035-08-01",{"name":357,"class":42},41,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":453,"conditions":454,"keywords":455,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":468},"100556651","study-to-assess-real-world-effectiveness-of-belimumab-for-treatment-of-adults-with-ln-100556651","NCT06527872","Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN","The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study","OBSErve-LN","Inclusion Criteria:\n\n* Participants to provide a signed informed consent at the time of enrollment per protocol,\n* Male or female aged 18 or over at initiation of belimumab,\n* Participants received belimumab in any formulation (subcutaneous or intravenous) for the treatment of active LN prescribed as per local label in combination with standard immunosuppressive therapy\u002Fies at initiation of belimumab,\n* Participants initiated belimumab 6 to 24 months prior to study enrollment,\n* Accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy at any time prior to belimumab initiation),\n* Biopsy-confirmed LN diagnosis at any time prior to belimumab initiation for treatment of LN\n* Class III (focal LN) with or without Class V (membranous LN),\n* Class IV (diffuse LN) with or without Class V,\n* Class V.\n\nExclusion Criteria:\n\n* Participants receiving renal replacement therapy (i.e., dialysis, kidney transplant, or those in end-stage kidney disease) at initiation of belimumab,\n* Participant is concomitantly receiving another SLE targeted monoclonal antibody (MAb), or a MAb expected to compromise immune responses, at initiation of belimumab,\n* Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies),\n* Participant is pregnant at the initiation of belimumab,\n* Participant with a kidney transplant at the initiation of belimumab,\n* Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.",{"count":452,"type":22},300,"The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.",[30],[456,318,449,457,458],"Belimumab","Renal function","Real world data","2026-07-01",{"date":461,"type":35},"2026-07-02",{"date":463,"type":35},"2024-10-04",{"date":465,"type":22},"2029-03-29",{"name":467,"class":42},"GlaxoSmithKline",7,{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":79,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":126},"100538011","phase-1-the-bcmacd19-dual-targeted-car-t-cell-in-participants-with-autoimmune-kidney-diseases-100538011","NCT06285279","The BCMA\u002FCD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases","Evaluation of the Safety and Efficacy of the BCMA\u002FCD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases: A Single-center Exploratory Clinical Study","Inclusion Criteria:\n\n1. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study.\n2. Participants must be aged ≥18 and ≤65 years.\n3. Disease-specific inclusion criteria:\n\n   Active, relapsing, refractory Lupus Nephritis (LN):\n\n   LN diagnosed by kidney biopsy within the last 2 years, with pathological types III, IV, or V, and a chronicity index (CI) score≤3\n\n   Meets one of the following criteria:\n\n   Refractory LN, defined as no remission after at least one standard regimen (CTX and\u002For MMF) for 6 months.\n\n   Relapsing LN, defined as a need to increase steroid dosage to control disease activity during maintenance treatment.\n\n   Clinical criteria: eGFR \\> 45 ml\u002Fmin\u002F1.73 m²; urinary protein quantification ≥ 1.5g\u002F24h; SLE-DAI score ≥ 8.\n\n   ANCA-associated vasculitis (AAV) patients:\n\n   Diagnosed as AAV according to the 2012 Chapel Hill Consensus Conference criteria, meeting one of the following:\n\n   Newly diagnosed AAV with renal involvement:\n\n   Renal involvement must meet both:\n\n   Kidney biopsy showing pauci-immune necrotizing glomerulonephritis. Urinary red blood cells \\>30\u002Fhigh power field.\n\n   Relapsing or refractory AAV:\n\n   Relapse: Defined as an increase in BVAS V3.0 score of ≥1 after remission, requiring adjustment of immunosuppressive treatment to regain remission.\n\n   Refractory: Defined as a) less than 50% reduction in BVAS V3.0 after 6 weeks of standard induction treatment; or b) persistent disease activity (BVAS V3.0 ≥3) after 12 weeks of treatment.\n\n   Membranous nephropathy (MN) patients:\n\n   Tissue biopsy diagnosed as aPLA2R-related membranous nephropathy.\n\n   Clinical criteria for high-risk or relapsing\u002Frefractory membranous nephropathy:\n\n   High-risk patients:\n\n   Defined as meeting any of the following: eGFR normal, urinary protein \\>3.5g\u002Fd, ACEI\u002FARB treatment for 6 months with \\\u003C50% reduction in urinary protein, combined with serum albumin \\\u003C25g\u002Fl or aPLA2R \\>50RU\u002Fml; or eGFR \\\u003C60ml\u002Fmin\u002F1.73m², and\u002For urinary protein \\>8g\u002Fd for over 6 months.\n\n   Refractory\u002Frelapsing membranous nephropathy patients:\n\n   Refractory: Defined as resistance to previous immunosuppressive treatment (persistent urinary protein ≥3.5g\u002Fd with \\\u003C50% reduction compared to baseline).\n\n   Relapse: Defined as complete or partial remission achieved with previous immunosuppressive treatment, followed by reappearance of urinary protein ≥3.5g\u002Fd.\n\n   eGFR ≥ 45 ml\u002Fmin\u002F1.73 m².\n\n   IgG4-related disease patients:\n\n   Meeting the 2019 ACR\u002FEULAR diagnostic criteria for IgG4-related disease, and meeting one of the following:\n\n   Newly diagnosed active IgG4-related disease (Respond Index (RI) ≥3).\n\n   Refractory or relapsed IgG4-related disease:\n\n   Refractory: Defined as no remission with steroid or steroid plus immunosuppressant treatment (no clinical or imaging improvement, RI decrease \\\u003C2) Relapse: Defined as new progression or recurrence of clinical symptoms or imaging findings in a patient who had achieved remission, with or without elevated blood IgG4 (RI increase≥2)\n4. Expected survival ≥ 12 weeks.\n5. ECOG performance status ≤ 2.\n6. Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of \\\u003C1% per year.\n7. Participants must have adequate organ function, meeting all of the following criteria before enrollment:\n\n   1. Absolute neutrophil count ≥ 1.0×10⁹\u002FL \\[Granulocyte colony-stimulating factor (G-CSF) support is allowed, but no supportive treatment should be received within 7 days before the assessment\\].\n   2. Platelet count ≥ 50×10⁹\u002FL \\[No transfusion support (including component transfusion) or treatments aimed\n\nExclusion Criteria:\n\n1. Participants who have received the following previous treatments:\n\n   1.1 Participants who have received gene therapy before enrollment. 1.2 Participants who have been injected with live vaccines within 4 weeks prior to enrollment.\n\n   1.3 Participants who have received other investigational drug treatments within 12 weeks before apheresis.\n2. Participants with active malignancies within the past 5 years, except for tumors deemed curable and cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.\n3. Participants who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA tests (defined as HBV DNA quantification above the lower limit of detection or above the normal reference range of the testing center, or qualitative HBV DNA test positive); positive for Hepatitis C virus (HCV) antibodies with positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis test RPR.\n4. Participants with uncontrolled active infections (except for \\\u003C Grade 2 CTCAE urinary reproductive system infections and upper respiratory infections).\n5. Participants with severe heart diseases, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ III), severe arrhythmias.\n6. Participants with hypertension or diabetes that cannot be controlled with medication.\n7. Participants with unresolved toxic reactions from previous treatments to baseline or ≤ Grade 1 (according to NCI-CTCAE v5.0, except for alopecia and clinically insignificant lab abnormalities).\n8. Participants who have undergone major surgery within 2 weeks prior to enrollment or plan to have surgery during the waiting period for infusion or within 12 weeks after receiving study treatment (except for planned minor surgeries under local anesthesia).\n9. Participants with solid organ transplants.\n10. Pregnant or breastfeeding women.\n11. Participants with a history of central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, dementia, psychosis, etc.) or consciousness disorders.\n12. Participants with other unstable systemic diseases as judged by the researcher, including but not limited to severe diseases of the liver, kidneys, gastrointestinal tract, or metabolic diseases requiring medication.\n13. Participants are known to have life-threatening allergic reactions, hypersensitivity, or intolerance to FKC289 cellular products or their components.\n14. Participants judged by the researcher to have bleeding, severe thrombosis, or hereditary\u002Facquired bleeding and severe thrombosis conditions (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or patients currently undergoing thrombolytic or anticoagulant therapy.\n15. Participants who have received any B cell-depleting therapy or non-depleting B cell targeted therapy within 6 months.\n16. Participants who have received high-dose methylprednisolone treatment (cumulative dose \\> 1.5g) or cyclophosphamide pulse therapy within a month.\n17. Participants judged by the researcher to be unable to discontinue other immunosuppressants one week before apheresis, or those treated with more than 5 mg\u002Fday of prednisone (or equivalent dose of other corticosteroids).\n18. AAV patients diagnosed with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) or with active alveolar hemorrhage.\n19. Other conditions deemed by the researcher as unsuitable for enrollment.",{"count":477,"type":22},24,[83],"This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\\^6 cells\u002Fkg, 1.0×10\\^6 cells\u002Fkg, 3.0×10\\^6 cells\u002Fkg, and an alternative dose of 0.1×10\\^6 cells\u002Fkg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).",[30,481,482,483],"ANCA-associated Vasculitis","Membranous Nephropathy - PLA2R Induced","IgG4-Related Diseases",{"date":485,"type":35},"2026-07-06",{"date":487,"type":35},"2024-03-04",{"date":489,"type":22},"2028-12-31",{"name":491,"class":71},"Nanjing University School of Medicine",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":499,"maxAge":19,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":511,"locationsCount":4},"100644839","rituximab-combining-with-low-dose-mycophenolate-mofetil-on-proliferative-lupus-nephritis-in-children-100644839","NCT07675291","Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children","Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children","Inclusion Criteria:\n\n1. Children aged 3-18 years old, regardless of sex;\n2. SLE patients who meet the 2019 EULAR\u002FACR SLE criteria or the 2012 SLICC diagnostic criteria;\n3. Diagnosed as lupus nephritis and the classification was consistent with proliferative lupus nephritis (type III or IV, with or without type V);\n4. White blood cell count ≥3.0×10\\^9\u002FL, and lymphocyte count ≥ 0.5× 10\\^9\u002FL and CD20 (or CD19)≥1\u002Ful;\n5. No cyclophosphamide or rituximab induction therapy was used before enrollment;\n6. Informed consent form is signed by the guardian and children over 8 years old;\n7. In the active stage of the disease, the 24-hour urine protein quantification ≥25mg\u002Fkg, or the urine protein\u002Fcreatinine ≥1.0mg\u002Fmg;\n8. Estimated GFR≥60ml\u002Fmin\u002F1.73m\\^2 (improved Swchartz formula).\n\nExclusion Criteria:\n\n1. Patients with lupus encephalopathy;\n2. Estimated GFR\\\u003C60ml\u002Fmin\u002F1.73m\\^2(Swchartz formula);\n3. HBV-antigen positive, HCV or HIV antibody positive;\n4. Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis;\n5. Allergic to the active ingredients or any auxiliary materials in rituximab, mycophenolate mofetil or cyclophosphamide;\n6. Severe heart failure and liver function damage;\n7. Patients who is not suitable to participate in this study judged by the researchers.","3 Years",{"count":501,"type":22},112,[370],"The objective of this study is to assess the efficacy and safety of rituximab combining with low-dose mycophenolate mofetil in the induction therapy of proliferative lupus nephritis in children.",[30],"2026-06-29",{"date":507,"type":35},"2026-06-30",{"date":509,"type":22},"2026-06",{"date":489,"type":22},{"name":512,"class":71},"Nanfang Hospital, Southern Medical University",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":522,"conditions":523,"keywords":524,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":126},"100644262","biomarker-development-for-autoimmune-disorders-involving-the-kidneys-100644262","NCT07666711","Biomarker Development for Autoimmune Disorders Involving the Kidneys","SILENT_LN","Inclusion Criteria:\n\n* Age 18 years or older\n* Established diagnosis of systemic lupus erythematosus according to accepted classification criteria\n* Receiving routine clinical care at Oslo University Hospital or another participating center\n* Able to provide informed consent according to the approved consent procedure\n* Willing and able to provide blood and\u002For urine samples for biomarker analysis\n* For the biopsy-validation analysis population: predefined increase or persistent elevation in one or more blood or urine biomarkers prompting structured renal assessment, with integrated medical assessment indicating suspected renal involvement, possible renal flare, unresolved uncertainty regarding renal inflammatory activity, or discordance between biomarker findings and conventional clinical measures\n\nExclusion Criteria:\n\n* Inability to provide valid informed consent, unless an approved alternative consent procedure applies\n* Known kidney disease not related to systemic lupus erythematosus that would prevent interpretation of lupus nephritis-related biomarker findings\n* Previous kidney transplantation\n* Active infection or acute medical instability that would interfere with study procedures or interpretation of biomarker findings in the time of sampling\n* For the biopsy-validation analysis population: kidney biopsy or re-biopsy is considered unsafe or inappropriate by the treating specialist\n* For the biopsy-validation analysis population: contraindication to native kidney biopsy according to local hospital procedures or specialist assessment\n* For the biopsy-validation analysis population: participant declines kidney biopsy, re-biopsy, or participation in the biopsy-validation component",{"count":521,"type":22},500,"SILENT-LN is a prospective observational cohort study of adults with systemic lupus erythematosus, including participants with no renal involvement, suspected renal involvement, active lupus nephritis, previous lupus nephritis, or inactive lupus nephritis. The study will measure pre-specified blood and urine biomarkers longitudinally during routine clinical care.\n\nThe study will evaluate whether blood and urine biomarker concentrations and biomarker panel scores are associated with active lupus nephritis, incident lupus nephritis, renal flare, treatment response, remission or inactive renal disease, kidney biopsy findings, and long-term renal outcomes.\n\nParticipants will provide blood and urine samples during routine clinical follow-up visits and at visits where renal involvement is clinically suspected. Clinical data, standard laboratory tests, disease activity assessments, kidney function measures, treatment information, and kidney biopsy findings, when available, will be recorded.\n\nA predefined increase or persistent elevation in blood or urine biomarker levels will trigger a structured renal assessment, and kidney biopsy or re-biopsy may be performed if the integrated clinical assessment indicates suspected renal involvement, renal flare, or uncertainty regarding renal inflammatory activity and the procedure is considered safe and clinically appropriate.\n\nThe study is currently conducted at Oslo University Hospital, Riks Hospital and may expand to additional centers following funding and regulatory approvals.",[30,29],[199,198,318,197,525,526,527,528,529,530,531,532,533,534,535],"Autoimmune kidney disease","Blood biomarkers","Urine biomarkers","Renal flare","Incident lupus nephritis","Active lupus nephritis","Treatment response","Renal remission","Kidney biopsy","Biomarker panel","Longitudinal monitoring","2026-06-24",{"date":505,"type":35},{"date":539,"type":22},"2026-06-15",{"date":541,"type":22},"2031-06-14",{"name":543,"class":71},"Oslo University Hospital",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":126},"100570561","phase-1-us-zamto-cel-autoimmune-diseases-100570561","NCT06708845","US Zamto-cel Autoimmune Diseases","A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects With Severe Refractory Autoimmune Diseases","General Key Inclusion\u002FExclusion Criteria Across All Cohorts\n\nInclusion Criteria:\n\n•Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc\u002F dcSSc)\n\nExclusion Criteria:\n\n* Prior gene therapy treatment\n* Active malignancy within past 5 years\n* Significant active fungal or bacterial infection\n* History or presence of CNS lupus or other CNS disease\n* eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2\n* Total bilirubin outside the normal range (unless congenital hyperbilirubinemia such as Gilbert syndrome has been confirmed).\n\nSystemic Lupus Erythematosus-Non-renal Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1 British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) organ scores\n* Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, or obinutuzumab\n\nExclusion Criteria:\n\n* Subjects with neuropsychiatric SLE.\n* Drug-induced SLE.\n\nSystemic Lupus Erythematosus - Lupus Nephritis Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Confirmed LN diagnosis by kidney biopsy during screening or within the previous 6 months, with severe active phase of the disease.\n* Progressing despite maintenance on maximally tolerated doses of renin- angiotensin system (RAS) blocking agents, unless allergic to or intolerant of ACE inhibitors and ARBs\n* Inadequate response to glucocorticoids and hydroxychloroquine and at least 1 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab, obinutuzumab, calcineurin inhibitor (cyclosporin, tacrolimus or voclosporin)\n\nExclusion Criteria:\n\n•Evidence of Rapidly progressive glomerulonephritis (defined as a doubling of serum creatinine within 3 months prior to enrollment) or as determined by the study investigator.\n\nSystemic Sclerosis\u002FDiffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion\u002F Exclusion Criteria\n\nInclusion Criteria:\n\n* Active disease defined as:\n* Modified Rodnan skin score (mRSS) ≥ 16 units, in the prior 6 months, with 1 or more of the following:\n\n  * Increase in mRSS by ≥ 3 units or 10%\n  * Involvement of 1 new body area with increase in mRSS by ≥ 2 units\n  * Involvement of 2 new body areas with increase by ≥ 1 mRSS unit OR\n* Progressive interstitial lung disease (ILD) defined as:\n\n  \\- Worsening of respiratory symptoms and an increased extent of fibrosis evaluated by high-resolution computed tomography\n* Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressive therapies)\n\nExclusion Criteria:\n\n* \"Active\" gastric antral vascular ectasia, as evidenced by bleeding (ie, on esophagogastroduodenoscopy) in the past 6 months or as per Investigator's assessment.\n* History of SSc renal crisis within 1 year prior to Screening; presence of kidney impairment due to conditions other than SSc",{"count":552,"type":22},48,[83],"AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc\u002FdcSSc) after receiving standard therapy.",[30,29,556,231],"Systemic Sclerosis (SSc)",[558,233,559,87,560,561,562,244,563,28],"Chimeric antigen receptor","Zamtocabtagene autoleucel","Immune System Diseases","SLE-Non renal","SLE-LN","dcSSc","2026-06-09",{"date":566,"type":35},"2026-06-11",{"date":568,"type":22},"2026-07",{"date":570,"type":22},"2028-07",{"name":572,"class":42},"Miltenyi Biomedicine GmbH",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":285,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":596},"100560749","phase-2-a-study-of-rapcabtagene-autoleucel-in-active-refractory-systemic-lupus-erythematosus-sle-or-lupus-nephritis-ln-patients-autograph---sleln-100560749","NCT06581198","A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE\u002FLN)","A Phase 2, Open-label, Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel in Patients With Active, Refractory Systemic Lupus Erythematosus (SLE) or Active, Refractory Lupus Nephritis (LN).","Key Inclusion Criteria:\n\n* Men and women with SLE, aged \\>= 18 years and =\\\u003C 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE at screening.\n* Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of \\>= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.\n* Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus\n* SLEDAI-2K Criteria at screening: SLEDAI-2K score \\>= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to \"fever\", \"lupus headache\", \"alopecia\", and \"organic brain syndrome\".\n* Inadequate response at screening to at least two therapies\n\nKey Exclusion Criteria:\n\n* Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and\u002For makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy\n* Inadequate organ function during screening and prior to randomization\n* History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization\n* Human immunodeficiency virus (HIV) positivity at screening.\n* Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.\n* Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":581,"type":22},179,[25],"The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).",[227,30],[586,587,430,195],"Chimeric Antigen Receptor-T (CAR-T)","rapcabtagene autoleucel","2026-06-02",{"date":590,"type":35},"2026-06-03",{"date":592,"type":35},"2024-09-04",{"date":594,"type":22},"2032-02-06",{"name":357,"class":42},101,{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":285,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":607,"conditions":608,"keywords":610,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":626},"100558910","phase-1-a-phase-12-study-of-nkx019-in-subjects-with-autoimmune-disease-ntrust-1-100558910","NCT06557265","A Phase 1\u002F2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)","A Phase 1\u002F2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Autoimmune Disease","General Inclusion Criteria:\n\n1. Age ≥18 and ≤75\n2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements\n3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose\n4. Progression despite maximal tolerated doses of renin-angiotensin system (RAS) blockade agents\n5. . For participants taking chronic corticosteroids for management of the disease under study, the prednisone (or equivalent) dose must be ≤20 mg\u002Fday at 2 weeks prior to Screening and stable for ≥ 14 days before start of Screening\n6. For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening\n\nLN-specific Inclusion Criteria:\n\n1. Score of 10 or more points on the American College of Rheumatology (ACR) 2019 classification criteria for SLE\n2. Active biopsy proven lupus nephritis Class III or Class IV without Class V overlap using the 2018 International Society of Nephrology and Renal Pathology Society (ISN\u002FRPS) criteria as evidenced on kidney biopsy during consent or within 6 months before screening. The biopsy must have at least mild to moderate activity score and no more than moderate chronicity index per NIH indices\n3. Active renal disease as defined by urinary protein:creatinine ratio (UPCR) ≥ 1.5 g\u002Fg or proteinuria ≥1.5 g\u002Fday on a 24-hour collection and ≤ 7 g\u002Fday by either measure\n4. One or more of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti-dsDNA OR positive anti-Smith (anti-Sm)\n5. Refractory LN defined as having received ≥ 2 prior therapies for LN (immunosuppressant and corticosteroid\u002For immunomodulatory agent, and corticosteroid at therapeutic range for at least 90 days), and had an inadequate response to therapy despite being on a therapeutic dose for ≥ 90 days\n\npMN-specific Inclusion Criteria:\n\n1. Evidence of pMN by renal biopsy during screening or within 6 months before screening\n2. Active renal disease at screening defined by spot UPCR ≥ 3.5 g\u002Fg or proteinuria ≥ 3.5 g\u002Fday on a 24-hour collection\n3. Presence of primary membranous nephropathy autoantibodies\n4. Refractory or intolerant to at least 1 induction therapy for pMN (immunosuppressant and corticosteroid or immunomodulatory agent and\u002Fcorticosteroid) and defined as not achieving a complete remission after 180 days, or partial remission after 90 days\n\nGeneral Exclusion Criteria:\n\n1. eGFR \\\u003C 45 ml\u002Fmin\u002F1.73 m\\^2\n2. Currently requiring renal dialysis or expected to require dialysis during the study period\n3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period\n4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy\n5. Liver disease or dysfunction, including cirrhosis and\u002For aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥ 3 times the upper limit of normal\n6. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\\\u003C92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \\>10 pack\u002Fyear) with active pulmonary disease\n7. Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \\\u003C 3,000\u002Fmm\\^3; hemoglobin levels \\\u003C 9 gm\u002FdL absolute neutrophil count \\\u003C 1500\u002Fmm\\^3; platelet count \\\u003C 100,000\u002Fmm\\^3\n8. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:\n\n   1. Uncontrolled angina or unstable life-threatening arrhythmias\n   2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019\n   3. Any prior coronary artery bypass graft surgery\n   4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency.\n   5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \\> 480 msec\n   6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019\n   7. Uncontrolled hypertension (systolic BP \\> 160mmHg and\u002For diastolic BP \\> 90mmHg) despite therapy\n9. Active bleeding disorders\n10. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis or any condition for additional immunosuppression is indicated); clinically significant conditions that could cause a secondary nephropathy (eg, infections, liver disease, tumors or drugs); or kidney biopsy-confirmed significant renal disease other than disease under study (eg, diabetic nephropathy, hypertensive nephropathy). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoid arthritis) are not excluded\n11. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions\n12. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD\n13. History of positive HIV antibody or test positive at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy\n14. Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the participant has not recovered or has ongoing complications\n15. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed\n16. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells\n17. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as active CNS lupus within 1 year prior to screening\n18. Any other acute or chronic medical or psychiatric condition, or known laboratory abnormality that, in the Investigator's opinion, is expected to interfere or impact study participation\n19. Current participation in another interventional clinical trial\n\n    a. Potential participants can be considered for enrollment after investigational product washout period of 5 half-lives or 30 days, whichever is longer\n20. Currently taking or known need for any of the medications prohibited in the study protocol\n21. Known hypersensitivity or contraindications to the study treatment including LD; or other components such as human serum albumin or dimethyl sulfoxide\n\nLN-specific Exclusion Criteria:\n\n1\\. Known clinically active antiphospholipid antibody syndrome (APS); or high-risk profile",{"count":605,"type":22},120,[83,25],"This is a Phase 1\u002F2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.",[30,609],"Primary Membranous Nephropathy",[235,611,234,612,613,236,614,615,30,616,197,609,617],"CAR","NKX019","Interleukin 15","Immunotherapy","Adoptive cell therapy","Ntrust-1","pMN",{"date":619,"type":35},"2026-06-04",{"date":621,"type":35},"2024-06-13",{"date":623,"type":22},"2027-04",{"name":625,"class":42},"Nkarta, Inc.",19,{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":18,"minAge":135,"maxAge":51,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":635,"briefSummary":636,"conditions":637,"keywords":640,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":43},"100539833","phase-1-a-phase-1-study-of-ft819-in-b-cell-mediated-autoimmune-disease-100539833","NCT06308978","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease","Key Inclusion Criteria:\n\n* Age: 12 to 70 years old.\n* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.\n* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.\n* Health Status: Adequate organ function to tolerate treatment.\n* Consent: Able to provide informed consent or assent\u002Fobtain parental consent and comply with study procedures.\n\nKey Exclusion Criteria:\n\n* Pregnancy\u002FBreastfeeding: Women must not be pregnant or nursing.\n* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.\n* Active Infections: No recent or ongoing serious infections.\n* Recent Cancer or Prior Cell Therapy: No active\u002Frecent malignancies, prior CAR T-cell therapy, or organ transplant.\n* Allergies: No known allergies to study treatments.\n* Weight Restriction: Must weigh at least 50 kg (110 lbs).",{"count":634,"type":22},244,[83],"This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.",[638,639,556,195,30],"Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)","Idiopathic Inflammatory Myositis (IIM)",[145,146,641,642,643,644,645,646,647,648,649,650,651,652,30],"Idiopathic inflammatory myositis (IIM)","Systemic lupus erythematosus (SLE)","Systemic sclerosis (SSc)","Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV)","Allogeneic CAR-T","CD19-Targeted Therapy","Cell Therapy for Autoimmune Diseases","B-Cell Depletion in Autoimmune Disease","Phase 1 Clinical Trial","Allogeneic CAR cells","Autoimmune Diseases","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases","2026-05-19",{"date":655,"type":35},"2026-05-22",{"date":657,"type":35},"2024-03-28",{"date":659,"type":22},"2042-09-30",{"name":146,"class":42},{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":667,"targetDuration":4,"studyType":23,"phases":669,"briefSummary":670,"conditions":671,"keywords":673,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":684},"100549464","phase-1-phase-iii-study-of-ad-plureceptor-plus-tafasitamab-cxix-and-lymphodepleting-chemotherapy-in-patients-with-autoimmune-disorders-100549464","NCT06434363","Phase I\u002FII Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders","Inclusion Criteria:\n\nSSc Specific Inclusion Criteria\n\nA. Diagnosis of SSc defined as follows:\n\ni) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening.\n\nB. SSc disease activity i) Diffuse SSc meeting the following criteria:\n\n(1) Disease duration ≤ 7 years (from onset of first non-Raynaud manifestation) AND (2) mRSS ≥ 15 at screening (Appendix 1) OR ii) Participants diagnosed with diffuse or limited cutaneous SSc AND presence of ILD changes on HRCT AND Disease duration ≤ 7 years (from onset of first non- Raynaud manifestation) AND either (1) or (2)\n\n1. Progressive ILD as defined by Raghu et al47 (≥ 2 of the following):\n\n   (a) worsening respiratory symptoms (b) physiological evidence of disease progression (≥ 1 of the following): (i) Absolute decline in FVC ≥ 5% predicted within 1 year of follow-up (ii) Absolute decline in DLCO (corrected for Hb) ≥ 10% predicted within 1 year of follow-up radiological evidence of disease progression (c) radiological evidence of disease progression (≥ 1 of the following):\n\n   (i) Increased extent or severity of traction bronchiectasis and bronchiolectasis.\n\n   (ii) New ground-glass opacity with traction bronchiectasis (iii) New fine reticulation (iv) Increased extent or increased coarseness of reticular abnormality.\n\n   (v) New or increased honeycombing (vi) Increased lobar volume loss\n2. FVC \\\u003C 80% predicted or extent of ILD changes on HRCT \\> 20%. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, and\u002For tocilizumab\n\nSLE Specific Inclusion Criteria\n\n1. A clinical diagnosis of SLE, based on the 2019 EULAR\u002F ACR classification criteria for adult SLE.\n2. Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening or prior to screening.\n3. For LN subjects only: Active, biopsy-proven lupus nephritis (kidney biopsy should have been done within 1 year of study enrollment) class III or IV, with or without the presence of Class V, using the 2018 Revised International Society of Nephrology\u002FRenal Pathology Society criteria48.\n4. Diagnosed with active SLE. Subjects with either LN or without LN will be eligible if they meet the following criteria:\n\n   a. For LN subjects: urine protein-to-creatinine ratio (UPCR) ≥0.5 g\u002Fg on 2 first morning void urine samples during screening despite prior or current treatment with standard of care therapy for at least 12 weeks, including corticosteroids, MMF\u002Fmycophenolic acid (MPA), CY, calcineurin inhibitors, belimumab, and\u002For rituximab. Patients should have failed at least 2 standard of care immunosuppressive therapies tried for 3 months, b. For non-renal SLE subjects: SLEDAI-2K ≥8 and clinical SLEDAI-2K ≥6 (excluding headache, alopecia, mucosal ulcers, fever, and organic brain syndrome) or ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and\u002For constitutional organ system) during screening despite prior or current treatment with standard of care therapy, including corticosteroids, rituximab or other B cell depleting agents, CY, MMF\u002FMPA, azathioprine, methotrexate, 6-mercaptopurine, sirolimus, tacrolimus, thalidomide, leflunomide, mizorbine, anifrolumab, and\u002For belimumab. Patients should have failed at least 2 standard of care immunosuppressive therapies tried for 3 months, or failed due to intolerance, or unable to obtain medication.\n5. If a subject is currently receiving:\n\n   1. A renin-angiotensin-aldosterone inhibitor, (including direct renin inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and mineralocorticoid receptor blockers), the subject must be on a stable dose for at least 8 weeks prior to screening. A sodium-glucose cotransporter-2 (SGLT2) inhibitor, the subject must be on a stable dose for at least 8 weeks prior to screening.\n   2. Regarding oral corticosteroid, doses \\\u003C0.5 mg\u002Fkg prednisone equivalent at the time of enrollment are required. Steroid taper to ≤10 mg prednisone equivalent prior to lymphodepleting chemotherapy is recommended.\n\nChronic GVHD specific inclusion criteria\n\n1. The patient has a history of steroid resistant chronic graft versus host disease (SR- chronic GVHD) or is intolerant of or has unacceptable complications with steroids.\n\n   Definition of SR-chronic GVHD - Chronic GVHD that does not respond adequately to full-dose prednisone. Any of the following conditions would be considered SR-chronic GVHD:\n   * Progressive symptoms \u002F manifestations of chronic GVHD despite receiving prednisone 1 mg\u002Fkg\u002Fday (or equivalent) for two weeks\n   * Stable symptoms \u002F manifestations of chronic GVHD after four to six weeks of prednisone ≥0.5 mg\u002Fkg\u002Fday (or equivalent)\n   * Inability to taper prednisone to \\\u003C0.5 mg\u002Fkg\u002Fday (or equivalent) without worsening of symptoms \u002F manifestations of chronic GVHD\n2. Disease activity:\n\n   • Manifestations\u002Fsymptoms of chronic GVHD rated as moderate to severe on the NIH chronic GVHD global severity score.\n3. Manifestations\u002Fsymptoms of chronic GVHD that have not adequately responded or intolerant to both:\n\n   * Ruxolitinib\n   * Belumosudil.\n4. May be receiving adrenal replacement doses of corticosteroids\n\nInclusion Criteria: For SLE, SSc, and chronic GVHD\n\n1. Able to provide informed consent.\n2. Age ≥18 to ≤80 years.\n3. Adequate organ function i) Peripheral blood absolute neutrophil count (ANC) ≥ 1 × 109\u002FL, unless the neutropenia is deemed to be caused by the underlying autoimmune disease.\n\nii) Hemoglobin ≥ 8 g\u002Fdl, unless the anemia is deemed to be caused by the underlying autoimmune disease.\n\niii) Platelet count ≥ 50 × 109\u002FL without platelet transfusion support, unless the thrombocytopenia is deemed to be caused by the underlying autoimmune disease. No clinically significant active bleeding.\n\niv) Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) and total bilirubin ≤ 3 × ULN (or direct bilirubin ≤ 3 × ULN with documented Gilbert's syndrome).\n\nv) Oxygen saturation (SaO2) ≥ 92% on room air (as measured by forehead probes in SSc patients).\n\nvi) Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n\nvii) Adequate renal function, defined as serum creatinine ≤ 2x ULN and estimated Glomerular Filtration Rate (eGFR using the CKD-EPI equation) ≥ 30 ml\u002Fmin\u002F1.73 m2 5. Recovery to ≤ Grade 1 or baseline of any non-hematological toxicities due to prior therapy.\n\n6\\. Negative pregnancy test in WOCBP. 7. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of therapy. Acceptable forms of birth control for female patients include hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor. Participant is willing and able to adhere to the study visit schedule and other protocol requirements and willing to sign informed consent.\n\nExclusion Criteria:\n\nSSc specific exclusion criteria\n\n1. SSc related pulmonary arterial hypertension (PAH) requiring active treatment.\n2. Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.\n3. Prior scleroderma renal crisis.\n4. Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \\\u003C 40% or FVC \\\u003C 40% of predicted or O2 saturation \\\u003C 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.\n\n   SLE specific Exclusion Criteria\n\n   Subjects are excluded from the study if any of the following criteria apply:\n5. For LN subjects only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+ for any of the following\n\n   individual biopsy features: total glomerulosclerosis score, fibrous crescents, tubular atrophy, or interstitial fibrosis.\n6. The presence of biopsy-proven kidney disease other than active lupus nephritis\n7. Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \\\u003C 40% or FVC \\\u003C 40% of predicted or O2 saturation \\\u003C 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.Active, severe cardiac manifestations of SLE, including constrictive pericarditis, hemodynamically significant pericardial effusions, and myocarditis at the time of screening.\n\n   Exclusion Criteria for Chronic GVHD\n8. Treatment with any immunosuppressive drug (except steroids) within 5 half lives prior to administration of lymphodepleting therapy.\n\n   Immunosuppressive Drug Five Half Lives Half Life of the Drug Axatilimab 23 days 108 hours Belumosudil 4 days 19 hours Cyclophosphamide 3 days 3-12 hours Ibrutinib 2 days 4-6 hours Ruxolitinib 2 days 5.8 hours Sirolimus 13 days 62 hours Tacrolimus 8 days 2.1-36 hours Tocilizumab 9 weeks 5-13 days\n9. Receiving any immunosuppressive medications that are not being used for management of chronic GVHD.\n10. Treatment with steroids ≥0.5 mg\u002Fkg prednisone daily or equivalent at the time of enrollment and \\>10 mg prednisone daily or equivalent at the time of lymphodepletion.\n11. Received rituximab within 6 months of lymphodepletion.\n\n    Exclusion Criteria for SLE, SSc, and chronic GVHD\n\n    Subjects are excluded from the study if any of the following medical conditions apply:\n12. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol.\n13. Active, clinically significant central nervous system pathology\n14. Prior history of malignancies or lymphoproliferative disease, following are allowed: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or breast or Smoldering Myeloma. History of malignancy that has been treated with a curative intent and is in remission may be allowed after discussion with PI.\n15. Active hepatitis C, active syphilis, any human immunodeficiency virus (HIV), human lymphocytic T-cell virus type 1 and\u002For type 2 (HTLV-1 and\u002For HTLV-2\n16. Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti- infective treatment at screening or within 72 hours before LD chemotherapy, or 5 days before AD-PluReceptor administration.\n17. History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association, myocardial infarction, unstable angina, or other clinically significant cardiac disease.\n18. Prior CAR T cell therapy, genetically modified T cell therapy.\n19. Treatment with cyclophosphamide within 3 days, tocilizumab within 9 weeks, and\u002For any other immunosuppressive drug (excluding steroids) within 5 half-lives prior to administration of lymphodepleting chemotherapy. Immunosuppressive medications are allowed if not being used for management of SLE, LN or SSc.\n20. Treatment with mycophenolate mofetil within 4 days prior to administration of lymphodepleting chemotherapy. For patients who will receive tafasitamab alone may continue mycophenolate mofetil throughout the study.\n21. History of anaphylactic or severe systemic reaction to FLU, CY, Tafasitamab, or any of their metabolites.\n22. Uncontrolled infection at screening.\n23. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal (on TPN), pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n24. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures.",{"count":668,"type":22},47,[83,25],"The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN.\n\nThe goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.\n\nThe goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.",[672,228,29,28,30],"Autoimmune Disorders",[674],"CAR NK, CAR, Natural Killer, SSc, SLE, LN, GVHD, Chronic GVHD","2026-04-10",{"date":677,"type":35},"2026-04-15",{"date":679,"type":35},"2024-07-31",{"date":681,"type":22},"2030-12-31",{"name":683,"class":71},"M.D. Anderson Cancer Center",2,{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":692,"enrollmentInfo":693,"targetDuration":263,"studyType":55,"phases":4,"briefSummary":695,"conditions":696,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":698,"startDateStruct":699,"completionDateStruct":701,"leadSponsor":703,"locationsCount":7},"100511031","lupus-landmark-study-a-prospective-registry-and-biorepository-100511031","NCT05934149","Lupus Landmark Study: A Prospective Registry and Biorepository","Lupus Nexus Landmark Study: A Prospective Registry and Biorepository","Inclusion Criteria:\n\n* Able to understand and comply with study procedures and voluntarily sign a written informed consent document\n* Age 18 years or older at the time of enrollment\n* Fulfill criteria for SLE based on one or more of the following classifications systems:\n\nSystemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 criteria; European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 criteria; 1997 revised ACR criteria; or Lupus is present per clinical assessment.\n\nExclusion Criteria:\n\n* Not able to obtain consent\n* Not able to meet protocol visit requirements\n* Pregnant at the time of enrollment","110 Years",{"count":694,"type":22},3500,"The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).",[195,30,697],"Neuropsychiatric Systemic Lupus Erythematosus",{"date":677,"type":35},{"date":700,"type":35},"2023-06-28",{"date":702,"type":22},"2035-12",{"name":704,"class":71},"Lupus Research Alliance"]