[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lupus-nephritis---who-class-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lupus-nephritis---who-class-iii":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100636836","phase-2-a-phase-2-open-label-single-arm-trial-of-ft819-in-participants-with-lupus-nephritis-100636836",false,"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","ALL","12 Years","70 Years",{"count":21,"type":22},53,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28,29,30,31,32],"Lupus Nephritis","Systemic Lupus Erythematosus","SLE - Systemic Lupus Erythematosus","Lupus Nephritis - WHO Class III","Lupus Nephritis - WHO Class IV",[34,35,36,37,28,29],"FT819","Fate Therapeutics","Allogeneic CAR T","CD19 - targeted therapy","NOT_YET_RECRUITING","2026-05-07",{"date":41,"type":42},"2026-05-11","ACTUAL",{"date":44,"type":22},"2026-07-01",{"date":46,"type":22},"2030-01-31",{"name":35,"class":48},"INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100601220","early-phase-1-safety-and-efficacy-of-ont01-in-lupus-100601220","NCT07107659","Safety and Efficacy of ONT01 in Lupus","Safety and Efficacy of ONTO1 in Lupus","Inclusion Criteria:\n\n1. ≥ 18 years old and able to provide informed consent to participate.\n2. Diagnosis of SLE and have fulfilled the ACR classification criteria for SLE during the course of their disease.\n3. Active non-renal SLE, with one active non-renal clinical manifestation, who have failed at least 1 disease modifying anti-rheumatic drug (DMARD) therapy (not including hydroxychloroquine and corticosteroids)\n\n   * Active non-renal SLE is defined as having a SLEDAI of 6 or greater (with at least 1 non-renal clinical domain) OR Active nephritis defined as having a no or partial response after initial induction and maintenance therapy with mycophenolate mofetil (and other standard of care therapies) for 3 months or more for class III, IV, IV, V (or combination) nephritis.\n   * Active LN is defined as follows: a. kidney biopsy showing Class III, IV, V, III+V, or IV+V, within 1 year from screening, AND b. 24-hour urine protein\u002Fcreatinine ratio \\>=1g\u002Fg at screening, AND c. absence of partial renal response (PRR)\n   * Partial renal response (PRR) is defined as a. 24-hour UPCR improved by \\>=25% after 3 months from the start of induction standard of care (SOC) therapy (baseline), or \\>= 50% after 6 months from the induction therapy (UPCR), AND b. 24-hour UPCR\\\u003C2g\u002Fg if baseline was \\\u003C 3g\u002Fg, OR \\\u003C 3g\u002Fg if baseline at induction was \\>= 3g\u002Fg. AND d. EGFR\\>=60 ml\u002Fmin\u002F1.73 M2 or no less than 80% of Baseline eGFR (at induction) AND e. No intercurrent rescue therapy, death, or early SOC treatment discontinuation or study withdrawal No response (NR) is defined as a. no achievement of at least a partial renal response, OR b. use of intercurrent rescue therapy, OR c. death\n4. Female patients who are women of childbearing potential must agree to use a highly effective form of contraception during the study and for at least 120 days after last exposure to study drug. Male patients with female partners of childbearing potential must use effective barrier contraception (i.e., condoms) during the study and for at least 120 days after last exposure to study drug. Also, patients may not proceed with sperm or egg donation during the study and for at least 120 days after the last exposure to study drug\n\nExclusion Criteria:\n\n1. Any condition, including any uncontrolled disease (eg, asthma, interstitial lung disease, pulmonary arterial hypertension, morbid obesity), that in the Sponsor-Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation.\n2. Active central nervous system SLE associated with significant cognitive impairment leading to inability to provide informed consent and\u002For comply with the protocol.\n3. Comorbidities requiring systemic corticosteroid (CS) therapy, such as asthma or inflammatory bowel disease. Systemic is defined as oral, rectal or any injectable route of administration (thus stable dosing by other routes is allowed, including inhaled, topical, ophthalmic, otic, and intranasal).\n4. Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of or during the Screening Visit, or completion of oral anti-infectives within 2 weeks before or during the Screening Visit.\n5. History of positive human immunodeficiency virus (HIV), hepatitis C antibody and\u002For polymerase chain reaction, hepatitis B surface antigen (HBsAg) (+), and\u002For hepatitis B core IgG and\u002For IgM antibody (+) at the Screening Visit.\n6. History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection (LTBI), determined by a positive QuantiFERON test at the Screening Visit\n7. History of malignancy (hematologic or solid tumor) within 10 years prior to Screening Visit, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or adequately treated carcinoma in situ\u002Fcervical intraepithelial neoplasia of the uterine cervix.\n8. Immunization with live or live-attenuated vaccines within 1 month before or during the Screening period.\n9. Initiation of, or change in, dosing of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker within 2 weeks before the Screening Visit or during the Screening period.\n10. Treatment with Voclosporin or Cyclophosphamide at time of screening.\n11. Treatment with other investigational agents within the last 3 months or 5 half-lives, or as per washout requirement from the previous protocol, whichever is longest, prior to the Screening Visit.\n12. Clinically significant abnormalities in laboratory tests, unless attributable to active SLE at the Screening Visit\n\n    * Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level \\> 2.5 × upper limit of normal (ULN), or\n    * Total bilirubin \\> 1.5 × ULN, or\n    * Hemoglobin \\\u003C 5.0 mmol\u002FL \\[9 g\u002FdL\\], or\n    * White blood cells \\\u003C 2.5 × 109\u002FL, or\n    * Absolute neutrophil count \\\u003C 1500 \u002Fmm3, or\n    * Platelets \\\u003C 75 × 109\u002FL\n13. Clinically significant chest imaging (e.g. X-ray, computed tomography or magnetic resonance imaging \\[MRI\\]) abnormalities per Sponsor-Investigator opinion (e.g. interstitial lung disease) or evidence of active TB on chest X-ray. Chest imaging study must have been performed in 3 months prior to the Screening Visit or during the Screening period.\n14. Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n15. Patients are unable or unwilling to adhere to the contraception requirements outlined in inclusion criteria 4.","18 Years",{"count":58,"type":22},61,[60],"EARLY_PHASE1","ONT01 is a drug that is being studied for the treatment of Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) and is not approved by the FDA. The purpose of this study is to better determine whether ONT01 is safe and tolerated by people with lupus nephritis or SLE. The study also looks at how the administration of ONT01 in combination with widely used treatments given for lupus, including the medication mycophenolate mofetil and others, can improve symptoms of lupus. A total of 61 participants will be enrolled in this study.",[63,31,32,64,65,66,29,67],"Lupus Nephritis (LN)","Lupus Nephritis - World Health Organization (WHO) Class III","Lupus","SLE","Systemic Lupus Erythematosus (Disorder)",[28,65,66],"RECRUITING","2025-11-19",{"date":72,"type":42},"2025-11-20",{"date":74,"type":22},"2026-09-04",{"date":76,"type":22},"2030-05",{"name":78,"class":79},"Hospital for Special Surgery, New York","OTHER",1]