Secondary Hemophagocytic Lymphohistiocytosis (sHLH) Clinical Trial
Official title:
A Phase 1b, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with secondary hemophagocytic lymphohistiocytosis.
This study is an open-label, single arm, multicenter interventional study, comprised of 4 cohorts; a dose escalating cohort (cohort 1) followed by 3 fixed dose cohorts (Cohorts 2-4). Newly diagnosed and previously treated participants with secondary hemophagocytic lymphohistiocytosis will be enrolled and treated over 12-weeks. Secondary hemophagocytic lymphohistiocytosis is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (m-HLH), infection, or autoimmune disease). ;