[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640281":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":30,"locations":38,"responsibleParty":52,"collaborators":29,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":29,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":29,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":29,"overallStatus":41,"whyStopped":29,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation and Expansion","EXPERIMENTAL","The study consists of a dose-escalation stage followed by an expansion stage. Participants in both stages will receive Cevostamab in a step-up dosing regimen, followed by a target dose.",[13,14],"Drug: Cevostamab","Drug: Tocilizumab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Cevostamab","Participants will receive cevostamab IV as per the schedule given in the protocol.",[9],[22],"RO7187797",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Tocilizumab","Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.",[9],[28],"Actemra\u002FRoActemra",null,[31,36],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Reference Study ID Number: GA46280 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":37,"role":33,"phone":29,"phoneExt":29,"email":29},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[39],{"facility":40,"status":41,"city":42,"state":29,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":29},"Hospital Universitario Virgen Macarena","RECRUITING","Seville","41009","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],-5.97317,37.38283,{"lat":50,"lon":49},{"type":53,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100640281","phase-1-to-evaluate-the-effects-of-cevostamab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640281",false,"NCT07629583","To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cevostamab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","Inclusion Criteria:\n\n* Diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criteria at least 6 months prior to the first screening visit\n* Active biopsy-proven LN established within 9 months of screening, demonstrating LN per 2018 Revised International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria\n* Diagnosis of active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score\n* Inadequate response or intolerance to, in the investigator's judgement, standard of care regimens for active SLE with or without LN\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n* Treatment with investigational or non-investigational biologic therapies that directly deplete B cells (e.g., anti-CD20 or anti-CD19 monoclonal antibodies) (or blinded comparators) is prohibited within 6 months or 5 drug elimination half-lives, whichever is longer, prior to screening and during the study\n* Treatment with investigational biologic therapies that do not directly deplete B cells (or blinded comparators) is prohibited within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug and during the study\n* Treatment of SLE\u002FLN with non-investigational biologic therapies that do not directly deplete B cells (e.g., belimumab, anifrolumab) is prohibited within 4 weeks prior to screening and during the study\n* Treatment with CYC within 3 months prior to screening or during the study\n* History of known or suspected allergic reaction or anaphylactic reaction to cevostamab or its excipients\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* History of serious recurrent or chronic infection\n* Tuberculosis (TB) infection\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\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, which, in the opinion of the investigator, is likely to require treatment with protocol-prohibited therapies\n* Non-SLE related CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease","ALL","18 Years","75 Years",{"count":65,"type":66},46,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).",[72],"Lupus Erythematosus, Systemic","2026-08-05",{"date":75,"type":76},"2026-08-07","ACTUAL",{"date":78,"type":66},"2026-10-31",{"date":80,"type":66},"2030-03-29",{"name":5,"class":6},1]