[{"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":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,60,0,25,[9,45,70,95,118,153,186,214,240,276,306,333,363,393,430,456,480,500,525,558,578,600,624,650,669],{"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":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100556651","study-to-assess-real-world-effectiveness-of-belimumab-for-treatment-of-adults-with-ln-100556651",false,"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.","ALL","18 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","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.",[26],"Lupus Nephritis",[28,29,16,30,31],"Belimumab","Lupus nephritis","Renal function","Real world data","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2024-10-04",{"date":40,"type":22},"2029-03-29",{"name":42,"class":43},"GlaxoSmithKline","INDUSTRY",7,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"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":56,"type":22},40,"INTERVENTIONAL",[59],"PHASE2","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.",[26],{"date":35,"type":36},{"date":64,"type":36},"2022-05-12",{"date":66,"type":22},"2030-06-14",{"name":68,"class":43},"Hoffmann-La Roche",42,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":18,"minAge":77,"maxAge":19,"enrollmentInfo":78,"targetDuration":4,"studyType":57,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"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":79,"type":22},112,[81],"NA","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.",[26],"NOT_YET_RECRUITING","2026-06-29",{"date":87,"type":36},"2026-06-30",{"date":89,"type":22},"2026-06",{"date":91,"type":22},"2028-12-31",{"name":93,"class":94},"Nanfang Hospital, Southern Medical University","OTHER",{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":57,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100640944","phase-2-a-study-to-evaluate-mosunetuzumab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640944","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",{"count":104,"type":22},30,[59],"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).",[108,109,26],"Lupus","Systemic Lupus Erythematosus","2026-06-26",{"date":87,"type":36},{"date":113,"type":36},"2026-05-25",{"date":115,"type":22},"2028-08-31",{"name":68,"class":43},15,{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"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":126,"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.",[26,109],[130,131,29,132,133,134,135,136,137,138,139,140,141,142,143],"Systemic lupus erythematosus","SLE","LN","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":85,"type":36},{"date":147,"type":22},"2026-06-15",{"date":149,"type":22},"2031-06-14",{"name":151,"class":94},"Oslo University Hospital",1,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":160,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":57,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100594172","phase-2-a-study-of-cc-97540-bms-986353-or-zola-cel-cd19-targeted-nex-t-car-t-cells-in-participants-with-active-sle-despite-immunosuppressants-breakfree-sle-100594172","NCT07015983","A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)","A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)","Inclusion Criteria:\n\n* Participants must meet EULAR\u002FACR 2019 criteria for SLE.\n* Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.\n* Participants must have active disease when signing ICF.\n\nExclusion Criteria:\n\n* Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.\n* Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies.\n* IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.\n* Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant.\n* Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration.\n* Participant must not have inadequate organ function.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","16 Years",{"count":162,"type":22},89,[59],"The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.",[166,26],"Lupus Erythematosus, Systemic",[108,131,132,168,169,170,171,172,173,174,175,176],"CAR T","Cell Therapy","CD19 CAR T","CD19","CD19 NEX-T","CD19 NEXT","CD19 NEX T","Zola-cel","Zolacabtagene autoleucel","2026-06-23",{"date":144,"type":36},{"date":180,"type":36},"2025-07-14",{"date":182,"type":22},"2032-06-15",{"name":184,"class":43},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",96,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":18,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":57,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"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","12 Years","65 Years",{"count":197,"type":22},35,[59],"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).",[26],[130,202,29,203,204],"Refractory systemic lupus erythematosus","Obecabtagene autoleucel","Obe-cel","2026-06-19",{"date":177,"type":36},{"date":208,"type":36},"2026-01-16",{"date":210,"type":22},"2029-10",{"name":212,"class":43},"Autolus Limited",10,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":57,"phases":224,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":117},"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":223,"type":22},150,[225],"PHASE4","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).",[26],[229,230],"voclosporin","calcineurin inhibitor","2026-06-11",{"date":233,"type":36},"2026-06-12",{"date":235,"type":36},"2026-04-22",{"date":237,"type":22},"2029-03-02",{"name":239,"class":43},"Aurinia Pharmaceuticals Inc.",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":57,"phases":250,"briefSummary":252,"conditions":253,"keywords":259,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":275},"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.","70 Years",{"count":249,"type":22},80,[251],"PHASE1","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).",[254,166,26,255,256,257,258],"SLE (Systemic Lupus)","Systemic Sclerosis","Inflammatory Myopathy, Idiopathic","Myositis","Diffuse Cutaneous Systemic Sclerosis",[168,108,131,26,260,171,169,261,257,262,263,264,265,266,267],"Allogeneic","Scleroderma","Systemic sclerosis","Idiopathic Inflammatory Myopathy","Inflammatory Myopathy","Diffused Cutaneous Systemic Sclerosis","Gene Therapy","Autoimmune",{"date":147,"type":36},{"date":270,"type":36},"2025-03-10",{"date":272,"type":22},"2031-12-31",{"name":274,"class":43},"CRISPR Therapeutics",14,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":57,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":152},"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":284,"type":22},48,[251],"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.",[26,109,288,258],"Systemic Sclerosis (SSc)",[290,168,291,292,293,294,295,296,297,108],"Chimeric antigen receptor","Zamtocabtagene autoleucel","Autoimmune Disease","Immune System Diseases","SLE-Non renal","SLE-LN","SSc","dcSSc","2026-06-09",{"date":231,"type":36},{"date":301,"type":22},"2026-07",{"date":303,"type":22},"2028-07",{"name":305,"class":43},"Miltenyi Biomedicine GmbH",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":221,"enrollmentInfo":313,"targetDuration":4,"studyType":57,"phases":315,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":332},"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":314,"type":22},179,[59],"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).",[166,26],[319,320,321,322],"Chimeric Antigen Receptor-T (CAR-T)","rapcabtagene autoleucel","Lupus Nephritis (LN)","Systemic Lupus Erythematosus (SLE)","2026-06-02",{"date":325,"type":36},"2026-06-03",{"date":327,"type":36},"2024-09-04",{"date":329,"type":22},"2032-02-06",{"name":331,"class":43},"Novartis Pharmaceuticals",101,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":221,"enrollmentInfo":340,"targetDuration":4,"studyType":57,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"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":341,"type":22},120,[251,59],"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.",[26,345],"Primary Membranous Nephropathy",[171,347,260,348,349,169,350,351,26,352,132,345,353],"CAR","NKX019","Interleukin 15","Immunotherapy","Adoptive cell therapy","Ntrust-1","pMN",{"date":355,"type":36},"2026-06-04",{"date":357,"type":36},"2024-06-13",{"date":359,"type":22},"2027-04",{"name":361,"class":43},"Nkarta, Inc.",19,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":57,"phases":373,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":392},"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":372,"type":22},240,[59],"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.",[26],[377,378,26,379,380,381,382,383,109],"LNP023","Iptacopan","proteinuria","Urine Protein-to-Creatinine Ratio","complete renal response","estimated glomerular filtration rate","renal flares","2026-05-28",{"date":386,"type":36},"2026-06-01",{"date":388,"type":36},"2022-08-10",{"date":390,"type":22},"2028-09-28",{"name":331,"class":43},103,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":194,"maxAge":247,"enrollmentInfo":399,"targetDuration":4,"studyType":57,"phases":401,"briefSummary":402,"conditions":403,"keywords":406,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":429},"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":400,"type":22},244,[251],"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.",[404,405,288,322,26],"Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)","Idiopathic Inflammatory Myositis (IIM)",[407,408,409,410,411,412,413,414,415,416,417,418,419,420,26],"FT819","Fate Therapeutics","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":423,"type":36},"2026-05-22",{"date":425,"type":36},"2024-03-28",{"date":427,"type":22},"2042-09-30",{"name":408,"class":43},21,{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":194,"maxAge":247,"enrollmentInfo":438,"targetDuration":4,"studyType":57,"phases":440,"briefSummary":441,"conditions":442,"keywords":446,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":453,"leadSponsor":455,"locationsCount":4},"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",{"count":439,"type":22},53,[59],"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.",[26,109,443,444,445],"SLE - Systemic Lupus Erythematosus","Lupus Nephritis - WHO Class III","Lupus Nephritis - WHO Class IV",[407,408,447,448,26,109],"Allogeneic CAR T","CD19 - targeted therapy","2026-05-07",{"date":451,"type":36},"2026-05-11",{"date":33,"type":22},{"date":454,"type":22},"2030-01-31",{"name":408,"class":43},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":57,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":479},"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":463,"type":22},47,[251,59],"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.",[467,255,109,108,26],"Autoimmune Disorders",[469],"CAR NK, CAR, Natural Killer, SSc, SLE, LN, GVHD, Chronic GVHD","2026-04-10",{"date":472,"type":36},"2026-04-15",{"date":474,"type":36},"2024-07-31",{"date":476,"type":22},"2030-12-31",{"name":478,"class":94},"M.D. Anderson Cancer Center",2,{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":487,"enrollmentInfo":488,"targetDuration":53,"studyType":23,"phases":4,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"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":489,"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).",[322,26,492],"Neuropsychiatric Systemic Lupus Erythematosus",{"date":472,"type":36},{"date":495,"type":36},"2023-06-28",{"date":497,"type":22},"2035-12",{"name":499,"class":94},"Lupus Research Alliance",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":507,"targetDuration":4,"studyType":57,"phases":509,"briefSummary":504,"conditions":510,"keywords":511,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":524},"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.",{"count":508,"type":22},28,[251,59],[109,26],[512,292,513,514,109,26],"CABA-201","Anti-CD19 CAR-T therapy","Cellular Therapy","2026-04-07",{"date":517,"type":36},"2026-04-09",{"date":519,"type":36},"2024-02-16",{"date":521,"type":22},"2029-12",{"name":523,"class":43},"Cabaletta Bio",23,{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":247,"enrollmentInfo":533,"targetDuration":4,"studyType":57,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":152},"100633196","phase-1-select-sle-biomarker-guided-car-t-target-selection-for-refractory-lupus-100633196","NCT07523542","SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus","A Phase 1\u002F2, Open-Label, Biomarker-Guided, Non-Randomized, Multicenter Study of Autologous CAR-T Cell Therapy Targeting CD19 or BCMA in Adults With Refractory Systemic Lupus Erythematosus With or Without Active Lupus Nephritis.","SELECT-SLE","Inclusion Criteria:\n\n* 1\\. Age 18 to 70 years at consent. 2. Meets 2019 EULAR\u002FACR classification criteria for SLE, with total score \\>= 10.\n\n  3\\. Active refractory disease at screening, defined by SELENA-SLEDAI \\>= 8, or at least one BILAG A domain, or at least two BILAG B domains, or active lupus nephritis with significant proteinuria and active urinary sediment.\n\n  4\\. Inadequate response, intolerance, or contraindication to at least 2 prior standard systemic regimens, including at least 1 immunosuppressant or biologic used for SLE or lupus nephritis. 5. Demonstrable targetable biology and assignment to one protocol arm: CD19 arm for measurable CD19-positive B-cell \u002F B-cell-dominant disease, or BCMA arm for BCMA-positive plasmablast \u002F plasma-cell-dominant disease and\u002For persistent serologic activity after prior B-cell depletion. 6. If active lupus nephritis is present, biopsy-proven class III, IV, V, or mixed proliferative \u002F membranous LN within the previous 24 months, or investigator confirmation that repeat biopsy is unsafe but the clinical picture strongly supports active LN. 7. Adequate organ function: hemoglobin \\>= 8.5 g\u002FdL, ANC \\>= 1.0 x 10\\^9\u002FL, platelets \\>= 50 x 10\\^9\u002FL, AST \u002F ALT \\\u003C= 2.5 x ULN, creatinine clearance \\>= 30 mL\u002Fmin, bilirubin \\\u003C= 2.0 mg\u002FdL unless otherwise explained, and LVEF \\>= 50%.\n\n  8\\. Adequate venous access and eligibility for leukapheresis. 9. Negative pregnancy test and agreement to use effective contraception for 12 months after infusion.\n\n  10\\. Ability to discontinue prohibited SLE medications per washout rules and willingness to comply with inpatient observation and long-term follow-up. 11. Written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Active uncontrolled infection, including active tuberculosis, hepatitis B or C with active replication, or HIV.\n\n  2\\. Prior CAR-T therapy or prior CD19- or BCMA-directed cell therapy. 3. Severe active CNS lupus requiring urgent escalation of immunosuppression, uncontrolled seizure disorder, or stroke within 60 days before screening. 4. End-stage organ failure not expected to improve with immune reset, such as dialysis-dependent kidney failure, uncontrolled advanced heart failure, or ICU-level respiratory instability. 5. Active malignancy or history of malignancy within 5 years, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or other low-risk malignancy in durable remission. 6. Pregnant or breastfeeding. 7. Allogeneic hematopoietic stem cell transplant or solid organ transplant history.\n\n  8\\. Contraindication to fludarabine, cyclophosphamide, leukapheresis, or standard rescue medications for CRS \u002F ICANS. 9. Live vaccine within 4 weeks before lymphodepletion. 10. Participation in another interventional clinical study within 3 months before enrollment.\n\n  11\\. Uncontrolled psychiatric disease, active substance misuse, or social circumstances that would impair adherence.\n\n  12\\. Any condition that, in the investigator's judgment, makes participation unsafe or confounds interpretation of the study endpoints.",{"count":534,"type":22},24,[251,59],"study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA. Participants undergo centralized screening immunophenotyping to determine whether their disease appears B-cell-dominant (CD19-preferred) or plasma-cell-dominant (BCMA-preferred), followed by leukapheresis, lymphodepletion, and a single CAR-T infusion. The main goals are to assess safety, determine a recommended Phase 2 dose within each arm, and estimate remission rates by Week 24.",[538,26],"REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS",[540,541,542,543,544,171,545,546,547,548],"autologous T cells","B-cell depletion","BCMA","biomarker-guided therapy","CAR-T","immune reset","lupus nephritis","plasma-cell depletion","refractory lupus","2026-04-05",{"date":551,"type":36},"2026-04-13",{"date":553,"type":36},"2026-03-02",{"date":555,"type":22},"2028-10-17",{"name":557,"class":43},"Beijing Biotech",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":565,"sex":18,"minAge":19,"maxAge":566,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":574,"leadSponsor":576,"locationsCount":4},"100631814","anti-alpha-actinin-antibodies-and-lupus-nephritis-activity-100631814","NCT07505576","Anti-alpha-actinin Antibodies and Lupus Nephritis Activity","Serum Anti-alpha-actinin Antibodies as an Early Biomarker for Histological Activity in Lupus Nephritis and Its Correlation With Other Conventional Serological Markers","Inclusion Criteria:\n\n1. Inclusion criteria for LN group:\n\n   1. Adult patients (≥ 18 and \\> 60 years) of either sex.\n   2. Fulfill the 2019 EULAR\u002FACR Classification Criteria for Systemic Lupus Erythematosus (SLE).\n   3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g\u002F24h, active urinary sediment, unexplained rise in serum creatinine).\n   4. Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) 2018 classification.\n   5. Renal biopsy performed within 3 months prior to enrollment, and patient has not received induction immunosuppressive therapy (cyclophosphamide, mycophenolate mofetil, or calcineurin inhibitors) in the period between biopsy and enrollment.\n   6. Provision of written informed consent.\n\n      b)Inclusion Criteria for Control Groups:\n\n   \u003C!-- -->\n\n   1. SLE without nephritis: Patients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria \\\u003C 0.3 g\u002F24h, normal serum creatinine).\n   2. Healthy controls: Age- and sex-matched healthy individuals with no history of autoimmune disease, normal urinalysis, and negative autoantibodies (ANA, anti-dsDNA).\n\n      Exclusion Criteria:\n\n      \\-\n\n      Participants will be excluded if ANY of the following criteria apply:\n\n   \u003C!-- -->\n\n   1. Other Kidney Diseases:\n\n      * Presence of, or suspicion of, any other primary or significant secondary kidney disease unrelated to SLE (e.g., diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, significant drug-induced nephrotoxicity, rheumatoid arthritis, positive HBs antigen or HCV antibody).\n   2. Confounding Clinical Conditions:\n\n      * Presence of an active or recent major infection (e.g., sepsis, pneumonia, UTI) at the time of enrollment, as infection can significantly alter immune markers.\n      * Presence of advanced chronic kidney disease (CKD Stage 4 or 5) predating the diagnosis of SLE.\n      * Pregnancy or lactation.\n   3. Confounding Medications:\n\n      * Receipt of high-dose corticosteroids (\\> 20 mg\u002Fday of prednisone or equivalent) or any potent immunosuppressive agent (e.g., cyclophosphamide, mycophenolate mofetil, rituximab) within 4 weeks prior to the renal biopsy and blood sampling).",true,"60 Years",{"count":185,"type":22},"Lupus nephritis (LN) develops in 30-60% of systemic lupus erythematosus (SLE) patients and remains a leading cause of morbidity, with 10-30% progressing to end-stage renal disease within 15 years. The International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) classifies LN histologically, with proliferative forms (Classes III\u002FIV) carrying the poorest prognosis.",[26],"2026-03-27",{"date":572,"type":36},"2026-04-01",{"date":572,"type":22},{"date":575,"type":22},"2027-10-01",{"name":577,"class":94},"Assiut University",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":57,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":597,"leadSponsor":598,"locationsCount":152},"100630898","therapeutic-drug-monitoring-of-mycophenolate-mofetil-in-lupus-nephritis-100630898","NCT07493655","Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis","Impact of Therapeutic Drug Monitoring of Mycophenolate Mofetil in Patients With Lupus Nephritis: A Randomized Clinical Trial","LUPUS-MONITOR","Inclusion criteria:\n\n* Adults aged ≥18 years, of both sexes\n* Diagnosis of systemic lupus erythematosus (SLE) according to the ACR criteria, with at least four criteria present for the diagnosis of SLE, and active lupus nephritis (class III-V) documented by renal biopsy with histological classification within the last 6 months or presence of urine protein-to-creatinine ratio (UPCR \\> 0.5) or 24-hour proteinuria (\\>500 mg)\n* Use of mycophenolate mofetil (MMF) in the maintenance phase within the first 3 months\n* Residents of the municipalities of São Luís, São José de Ribamar, and Paço do Lumiar, located in the Metropolitan Region of Greater São Luís\n\nExclusion criteria:\n\n* Individuals with contraindications to MMF (known hypersensitivity, pregnancy, or breastfeeding)\n* Active severe infection (e.g., tuberculosis, sepsis)\n* Unstable renal replacement therapy and severe hepatic failure\n* Use of investigational drugs\n* Concomitant use of drugs that strongly modify pharmacokinetics (PK) without the possibility of adjustment, such as rifampicin.",{"count":587,"type":22},100,[81],"Systemic lupus erythematosus (SLE) is an inflammatory, chronic, and multisystem autoimmune disease characterized by periods of activity and remission. Lupus nephritis (LN) is the most frequent renal complication and is associated with high morbidity, manifesting as nephritic or nephrotic syndrome, complement consumption, and positivity for anti-double-stranded DNA antibodies.\n\nMycophenolate mofetil (MMF) is an immunosuppressive agent that modifies the course of LN and is converted into mycophenolic acid (MPA), its measurable active metabolite. However, MMF exhibits complex interindividual and interethnic variability in metabolism, reinforcing the need for personalized strategies through therapeutic drug monitoring (TDM) to ensure renal remission.\n\nThe objective of this study is to determine whether the implementation of MPA TDM results in a higher rate of renal remission over 12 months compared with standard treatment.\n\nThis is a randomized, blinded clinical trial to be conducted at a teaching hospital in Maranhão over a 12-month period. From an estimated population of 187 eligible patients with LN receiving MMF, 100 consecutive participants will be randomized (50 per group).\n\nMPA monitoring will occur at three time points (T1, T2, T5), while clinical and laboratory outcome assessments will be performed quarterly (T1-T5). The primary outcome will be the renal remission rate; secondary outcomes include serum MPA levels, adverse events, hospitalizations, and medication adherence.\n\nThis study will generate evidence on precision therapeutics applied to MMF in LN within the Brazilian public health system (SUS), particularly regarding the pilot use of TDM for dose optimization and maximization of clinical response.",[109,26,591,592],"Drug Monitoring","Mycophenolic Acid","2026-03-23",{"date":595,"type":36},"2026-03-25",{"date":33,"type":22},{"date":91,"type":22},{"name":599,"class":94},"Federal University of Maranhao",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":608,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":57,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":362},"100480609","phase-2-the-pediatric-lupus-nephritis-mycophenolate-mofetil-plumm-study-100480609","NCT05538208","The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study","Efficacy & Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis- A Double-Blind Placebo Controlled Clinical Trial","PLUMM","Inclusion\n\n1. Male or female aged 8 to \\\u003C 21 years;\n2. Must meet Classification Criteria for SLE as per the criteria of the American College of Rheumatology (ACR)\u002F European League Against Rheumatism\n3. Diagnosed with proliferative LN as per the International Society of Nephrology\u002FRenal Pathology Society4 based on kidney biopsy done within 90 days prior to enrollment into the study;\n\n   Subjects may have been previously diagnosed with LN. For study inclusion, the kidney biopsy must be interpreted as one of the following classes: Class 3, Class 3\u002F5, Class 4, or Class 4\u002F5.\n4. Treatment of LN with twice daily MMF as per the decision of the treating physician.\n\n   The subject will have taken MMF as prescribed by their treating physician for a minimum of 4 days (or 8 doses).\n5. Subject tolerates MMF as per the treating physician's opinion;\n6. Able to swallow MMF tablets and capsules;\n7. If subject is treated with belimumab, must be IV or SQ;\n8. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;\n9. Evidence of a personally signed and dated Informed Consent document and Assent document (as appropriate) indicating that the subject and a legally acceptable representative\u002F parent(s)\u002Flegal guardian has been informed of all pertinent aspects of the study.\n10. Parent or legal guardian must have a smart phone available and able to support the PLUMM smart phone application.\n11. Must be able to complete study questionnaires in English or Spanish.\n\nExclusion Criteria:\n\n1. Perceived or stated inability to adhere to the study protocol;\n2. Hypersensitivity to MMF or any component of the drug product;\n3. Presence of features (from SLE or other chronic disease) that a-priori suggest that the subject benefits from other therapies than that suggested or allowable by the study protocol; These disease features include but are not limited to severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.\n4. History of other kidney disease besides LN or prior to the diagnosis of SLE;\n5. Need for renal replacement therapy within 2 weeks from Baseline Subjects can have required short-term renal replacement therapy prior to Baseline, for example due to preceding acute kidney injury.\n6. Infections:\n\n   1. Untreated latent or active tuberculosis (TB);\n   2. Chronic infections requiring treatment;\n   3. A subject known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B;\n   4. Diagnosis of any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within 4 weeks prior to Baseline visit;\n   5. Any treated infections within 2 weeks of Baseline visit;\n   6. History of infected joint prosthesis with prosthesis still in situ;\n7. Blood dyscrasias, including:\n\n   1. Hemoglobin \\\u003C8.5 g\u002FdL or Hematocrit \\\u003C22%;\n   2. White Blood Cell count \\\u003C2.6 x 109\u002FL;\n   3. Neutrophil count \\\u003C1.2 x 109\u002FL;\n   4. Platelet count \\\u003C100 x 109\u002FL;\n   5. Lymphocyte count \\\u003C0.5 x 109\u002FL.\n8. 8\\) Estimated glomerular filtration rate \\[GFR\\] \\\u003C40 mL\u002Fmin\u002F1.73 m2 calculated using the CKiD U25 equation (see Appendix 4);\n9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>1.5 times the upper limit of normal;\n10. Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to Baseline visit;\n11. History or current symptoms suggestive of lymphoproliferative disorders (e.g., Epstein Barr Virus \\[EBV\\] related lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma);\n12. Current malignancy or history of any malignancy with the exception of adequate treated or excised basal cell or squamous cell or cervical cancer in situ;\n13. Recent (within 4 weeks prior to Baseline visit) significant trauma or major surgery;\n14. Herbal supplements with pharmaceutical properties must be discontinued at least 1week prior to Baseline visit, unless there are sufficient data available regarding the duration of an herbal medication's pharmacokinetic and pharmacodynamic effects to allow a shorter or longer washout to be specified (e.g., 5 half-lives).\n15. Oral or intravenous cyclophosphamide must be discontinued 12 weeks prior to Baseline visit\n16. Use of prohibited prescription medication as listed in Appendix 3 within the specified time frame prior to Baseline visit\n17. Participation in other studies involving investigational drug(s) within 4 weeks or 5 half-lives (whichever is longer) prior to Baseline visit and\u002For during study participation; Exposure to investigational biologics should be discussed with the Sponsor.\n18. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use two highly effective methods of contraception or are abstinent for the duration of the study;\n19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.","8 Years","20 Years",{"count":611,"type":22},105,[59],"The study is a 1-year 2-part double-blinded placebo controlled 2-arm clinical trial. Treatment arms are (1) MMF dosed as per body-surface area (MMFBSA; 600mg\u002Fm2 body surface area per dose about every 12 hours) and (2) pharmacokinetically-guided precision-dosing of MMF (MMFPK; MMF dosed twice daily to achieve an area under the concentration-time curve (AUC0-12h) of MPA \\>60-70 mg\\*h\u002FL. The study goal is to determine the safety and efficacy of MMFPK compared to MMFBSA for the treatment of proliferative LN in subjects 8 to \\\u003C21 years.",[26],"2026-03-16",{"date":617,"type":36},"2026-03-18",{"date":619,"type":36},"2024-06-07",{"date":621,"type":22},"2027-01",{"name":623,"class":94},"Children's Hospital Medical Center, Cincinnati",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":370,"enrollmentInfo":632,"targetDuration":4,"studyType":57,"phases":634,"briefSummary":636,"conditions":637,"keywords":638,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":7},"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":633,"type":22},315,[635],"PHASE3","The purpose of this 2-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.",[26],[321,639,640,641],"B cell depletion","ianalumab","VAY736","2026-03-10",{"date":644,"type":36},"2026-03-11",{"date":646,"type":36},"2025-05-19",{"date":648,"type":22},"2032-07-16",{"name":331,"class":43},{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":221,"enrollmentInfo":657,"targetDuration":4,"studyType":57,"phases":658,"briefSummary":659,"conditions":660,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":667,"locationsCount":152},"100623193","phase-2-a-multicenter-phase-2a-clinical-study-to-evaluate-sim0278-in-subjects-with-active-lupus-nephritis-100623193","NCT07393451","A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis","A Randomized, Double-blind, Placebo, Parallel-Controlled, Multicenter Phase 2a Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SIM0278 in Subjects With Active Lupus Nephritis","Inclusion Criteria:\n\n1. Weight ≥ 40.0 kg\n2. SLE was diagnosed according to 2019 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria.\n3. Subjects must be receiving or willing to initiate induction therapy for LN. Induction therapy, defined as including high-dose glucocorticoids and MMF, should be initiated within 60 days or on the same day prior to baseline.\n\nExclusion Criteria:\n\n1. Previous or current nephropathy (except LN) that, in the opinion of the investigator, may interfere with the LN assessment and interfere with the assessment of disease activity (e.g., diabetic nephropathy). The subject was unable or unwilling to provide written informed consent and\u002For to comply with study procedures.\n2. Severe renal impairment: a) oliguria (defined as recorded urine volume \\\u003C 400 mL\u002F24 h), or b) end-stage renal disease (ESRD) requiring dialysis or transplantation.\n3. Previous induction therapy for MMF\u002FMPS was considered by the investigator to have failed.",{"count":5,"type":22},[59],"This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult (18-75 years) subjects with active LN suitable for systemic therapy.\n\nApproximately 60 subjects with active LN are planned to be enrolled and randomized 1: 1 to SIM0278 or placebo.\n\nThe study consists of 3 phases: screening, double-blind treatment, and safety follow-up.",[26],"2026-01-30",{"date":663,"type":36},"2026-02-06",{"date":665,"type":22},"2026-03-31",{"date":115,"type":22},{"name":668,"class":94},"Simcere Pharmaceutical Co., Ltd",{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":12,"sex":18,"minAge":677,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":57,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":4},"100620959","phase-1-efficacy-and-safety-of-crc01-in-participants-with-severe-refractory-systemic-lupus-erythematosus-100620959","NCT07364396","Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus","An Open-label, Multi-center, Single-arm Phase 1\u002F2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus","CRC01-02","Inclusion Criteria:\n\n* Age 19 years or older, voluntarily provides written informed consent.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria.\n* Positive antinuclear antibody (ANA) at screening (titer ≥1:80).\n* Diagnosis of lupus nephritis Class III or IV (with or without concurrent Class V), confirmed by kidney biopsy within 1 year prior to screening based on ISN\u002FRPS 2018 criteria.\n* Inadequate response to, or intolerance of, at least two or more standard therapies for 6 months or longer (cyclophosphamide, mycophenolate mofetil, azathioprine, tacrolimus, rituximab, belimumab).\n* Proteinuria at screening with urine protein-to-creatinine ratio (UPCR) \\>1.5.\n* Adequate laboratory values at screening: Hemoglobin \\>8.0 g\u002FdL; ANC \\>1,000\u002FμL; Platelets ≥50,000\u002FμL; Total bilirubin ≤2.0 × ULN; AST and ALT ≤3 × ULN; eGFR ≥30 mL\u002Fmin\u002F1.73 m².\n* Hemodynamically stable, no pericardial effusion, and LVEF ≥50% by echocardiogram at screening.\n* FEV1\u002FFVC ≥70% at screening.\n* Willing and able to comply with study visits, procedures, and requirements.\n* Women of childbearing potential and men must agree to use effective contraception for at least 1 year after CRC01 infusion until PCR testing confirms clearance of CRC01.\n\nExclusion Criteria:\n\n* Current or anticipated requirement for renal dialysis during the study.\n* History of kidney transplantation or planned transplantation during the study.\n* History of severe CNS lupus or currently active severe CNS lupus.\n* Prior CAR-T cell therapy.\n* History of malignancy except for: basal or squamous cell carcinoma of skin treated and disease-free ≥3 years; in-situ carcinoma of cervix or breast treated and disease-free ≥3 years; superficial bladder cancer treated and disease-free ≥3 years; completely resected primary malignancy in complete remission ≥5 years.\n* Unstable angina and\u002For myocardial infarction within 1 year prior to screening.\n* Congestive heart failure of NYHA Class III or IV within 1 year prior to screening.\n* Thromboembolism, pulmonary embolism, or clinically significant bleeding diathesis within 6 months prior to screening.\n* Hypoxemia, clinically significant pleural effusion, or abnormal ECG findings within 6 months prior to screening.\n* Stroke (ischemic or hemorrhagic) within 6 months prior to screening.\n* Positive HBsAg; positive anti-HCV (eligible if HCV RNA negative); known HIV infection; or active neurological autoimmune\u002Finflammatory diseases (e.g., Guillain-Barré syndrome, ALS).\n* Recurrent or symptomatic ventricular tachycardia, or atrial fibrillation with rapid ventricular response despite therapy within 3 months prior to screening.\n* Severe or uncontrolled active infection requiring systemic therapy at screening.\n* Rapidly progressive disease or otherwise unsuitable for study participation, per investigator judgment.\n* Pregnant or breastfeeding women.\n* Known hypersensitivity to investigational product components.\n* Participation in another investigational study within 4 weeks prior to screening.\n* Receipt of systemic corticosteroids at therapeutic doses within 7 days prior to leukapheresis (≤7.5 mg\u002Fday prednisone equivalent is permitted).\n* Receipt of immunosuppressive agents within 7 days prior to leukapheresis.\n* Receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to leukapheresis.\n\nInclusion Criteria for CRC01 Infusion:\n\n* No clinically significant worsening of organ function after screening.\n* If any of the following adverse events related to lymphodepleting chemotherapy exceed Grade 1 or worsen compared with screening, CRC01 infusion must be delayed:\n\n  * Requirement for supplemental oxygen\n  * New arrhythmia symptoms or clinically significant changes in cardiac function compared with screening\n  * Hypotension requiring treatment\n  * Active infection within 72 hours prior to the planned CRC01 infusion\n\n    * If bacterial, viral, or fungal infection is documented, improvement of symptoms must be documented before infusion.\n* Women of childbearing potential must have a negative urine pregnancy test prior to infusion.\n* If CRC01 infusion is delayed for more than 2 weeks after lymphodepleting chemotherapy, administration may proceed only with approval from the sponsor's medical monitor.\n* No receipt of therapeutic doses of systemic corticosteroids or immunosuppressive agents within 7 days prior to CRC01 infusion. (Prednisone ≤7.5 mg\u002Fday or equivalent is permitted.)\n* No receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to CRC01 infusion.","19 Years",{"count":679,"type":22},39,[251,59],"The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE).\n\nThe main objectives of the study are:\n\n1. To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis.\n2. To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity.\n\nStudy Design This is a single-arm, open-label, multi-center, Phase 1\u002F2 study. All enrolled participants will receive CRC01 after screening and baseline assessments.\n\nStudy Procedures\n\nParticipants will:\n\n* Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments.\n* Provide autologous T lymphocytes through a procedure called leukapheresis.\n* Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy).\n* Receive a single intravenous infusion of CRC01 cells.\n* Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity.\n* Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response.\n\nKey Outcomes\n\nResearchers will measure:\n\n* Changes in proteinuria and kidney function.\n* Changes in disease activity scores.\n* Incidence and severity of adverse events.",[26,321,131,254],"2026-01-21",{"date":685,"type":36},"2026-01-23",{"date":687,"type":22},"2026-02",{"date":689,"type":22},"2030-06",{"name":691,"class":43},"Curocell Inc."]