Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
This study tests a new medicine called ELA026 for treating secondary hemophagocytic lymphohistiocytosis (sHLH), a rare and serious condition where the immune system becomes overactive and attacks the body's own cells. sHLH often develops in people who have other serious health conditions like cancer or infections. The study will help researchers learn if ELA026 can safely and effectively control this dangerous immune response.
Key Objective:ELA026 may help control the excessive immune activation in secondary hemophagocytic lymphohistiocytosis and improve survival outcomes.
Who to Consider:People diagnosed with secondary hemophagocytic lymphohistiocytosis who have exhausted standard treatment options or are looking for additional therapeutic approaches should consider enrolling.
Trial Parameters
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Brief Summary
Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (mHLH), infection, or autoimmune disease). ELA026 is a fully human immunoglobulin G1 (IgG1) signal regulatory protein (SIRP)-directed monoclonal antibody designed to deplete 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 sHLH.
Eligibility Criteria
Key Inclusion Criteria for Part 1: 1. ≥12 years at the time of HLH diagnosis (Cohort 1). 2. ≥6 years at the time of HLH diagnosis (Cohort 2-3). 3. Treatment naïve or relapsed/refractory (Cohorts 1 and 2). 4. Treatment naïve or early refractory (Cohort 3). 5. Participant with sHLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria. Key Inclusion Criteria for Part 2: 1. Cohort A: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH. 2. Cohort B: Adults with newly diagnosed, treatment-naïve, non-malignancy-associated sHLH. 3. Cohort B: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index. 4. Cohort B: 13 to 17 years olds with newly diagnosed, treatment-naïve sHLH. 5. Cohort B: 6 to 12 year olds, with refractory sHLH (safety lead-in cohort). 6. Cohort B: 6 to 12 year olds, with newly diagnosed, treatment-naïve sHLH (after completion of safety lead-in cohort). Key Exclusion Criteria for Part 1: 1. Kno