Felzartamab
Felzartamab is a fully human immunoglobulin G1 monoclonal antibody designed to target the highly expressed CD38 cell surface antigen on plasma cells. Binding of Felzartamab to CD38+/CD20− plasma cells is thought to induce cell killing through two complementary mechanisms of action including antibody-dependent cell-mediated cytotoxicity (ADCC) via natural killer cells and antibody-dependent cell-mediated phagocytosis (ADCP) via macrophages.
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How is Felzartamab being studied in Lupus nephritis?
The safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis is being evaluated in an Open Label Phase 1b Study of Felzartamab in Lupus Nephritis. The primary endpoint is the number of participants with adverse events and the secondary endpoint is the change from baseline in Urine Protein: Creatinine Ratio, proportion of participants who achieve a complete renal response, or overall complete and partial renal response, change from baseline in serum creatinine.
Eligibility Criteria
Age 18-75 years
Class III or IV Lupus nephritis either with or without the presence of Class V, according to the 2003 ISN/RPS classification.
Proteinuria (urine protein to creatinine ratio) > 1.0 gram per gram (g/g), based on 24-hour urine collection
eGFR ≥ 45 ml/min/1.73 square meters (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula)
History of inadequate response, for lack of efficacy or intolerance, to at least a three-month course of one standard of care treatment for lupus nephritis