{ "data": { "asOf": "2026-10-30T22:24:35.864Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06975787", "title": "Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis", "scientificTitle": "A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE1" ], "conditions": [ "Lupus Nephritis (LN)" ], "interventions": [ { "name": "Vonsetamig", "type": "DRUG", "description": "Administered as per the protocol" }, { "name": "Odronextamab", "type": "DRUG", "description": "Administered as per the protocol" } ], "sponsor": { "name": "Regeneron Pharmaceuticals", "type": "INDUSTRY" }, "locations": [ { "city": "San Francisco", "country": "United States", "facility": "University of California San Francisco - Zuckerberg San Francisco General" }, { "city": "Gainesville", "country": "United States", "facility": "University of Florida" }, { "city": "Rochester", "country": "United States", "facility": "Mayo Clinic" }, { "city": "Houston", "country": "United States", "facility": "Baylor College of Medicine" }, { "city": "Bordeaux", "country": "France", "facility": "Centre Hospitalier Universitaire (CHU) Bordeaux" }, { "city": "Regensburg", "country": "Germany", "facility": "University Hospital Regensburg" }, { "city": "Mainz", "country": "Germany", "facility": "University Medical Center of the Johannes Gutenberg-University Mainz" }, { "city": "Anyang-si", "country": "South Korea", "facility": "Hallym University Sacred Heart Hospital" }, { "city": "Seoul", "country": "South Korea", "facility": "Seoul National University Hospital" }, { "city": "Seoul", "country": "South Korea", "facility": "Samsung Medical Center" }, { "city": "Seoul", "country": "South Korea", "facility": "Yonsei University College of Medicine, Severance Hospital" }, { "city": "Seville", "country": "Spain", "facility": "Hospital Universitario Virgen del Rocio" }, { "city": "Pamplona", "country": "Spain", "facility": "Clinica Universidad de Navarra" }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Gregorio Maranon" }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Universitario 12 de Octubre" }, { "city": "Málaga", "country": "Spain", "facility": "Hospital Regional Universitario de Malaga" }, { "city": "Changhua", "country": "Taiwan", "facility": "Changhua Christian Hospital" }, { "city": "Taichung", "country": "Taiwan", "facility": "Taichung General Veterans Hospital" }, { "city": "Taipei", "country": "Taiwan", "facility": "National Taiwan University Hospital" }, { "city": "Taipei", "country": "Taiwan", "facility": "Taipei Veterans General Hospital" } ], "outcomes": { "other": [], "primary": [ "Occurrence of Dose Limiting Toxicities (DLT)", "Occurrence of Treatment Emergent Adverse Events (TEAEs)", "Severity of TEAEs" ], "secondary": [ "Proportion of participants no longer receiving a corticosteroid", "Cumulative total exposure to corticosteroids", "Absolute values of urine Protein-Creatinine Ratio (uPCR)", "Percent change from baseline of uPCR", "Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine", "Percent change from baseline of eGFR serum creatinine", "Absolute values of blood B-cell counts and other immune cell populations", "Change from baseline of blood B-cell counts and other immune cell populations", "Absolute values of double-stranded DNA (dsDNA) antibodies", "Percent change from baseline of dsDNA antibodies", "Absolute values of anti-Smith antibodies", "Percent change from baseline of anti-Smith antibodies", "Absolute values of anti-C1q antibodies", "Percent change from baseline of anti-C1q antibodies", "Absolute values of other autoantibodies", "Percent change from baseline of other autoantibodies", "Absolute values of Complement Factor C3 (C3) circulating factors", "Percent change from baseline of C3 circulating factors", "Absolute values of Complement Factor C4 (C4) circulating factors", "Percent change from baseline of C4 circulating factors", "Absolute values of serum levels of Immunoglobulin A (IgA)", "Percent change from baseline of serum levels of IgA", "Absolute values of serum levels of Immunoglobulin G (IgG)", "Percent change from baseline of serum levels of IgG", "Concentrations of vonsetamig in serum", "Concentrations of odronextamab in serum", "Occurence of Anti-Drug Antibodies (ADAs) to vonsetamig", "Occurence of ADAs to odronextamab", "Magnitude of ADAs to vonsetamig", "Magnitude of ADAs to odronextamab" ] }, "eligibility": { "sex": "ALL", "criteria": "Key General Inclusion Criteria:\n\n1. 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