Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH) (NCT05416307) | Clinical Trial Compass
RecruitingPhase 2/3
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
United States156 participantsStarted 2022-05-19
Plain-language 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.
Who can participate
Age range6 Years
SexALL
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Inclusion criteria
✓. ≥12 years at the time of HLH diagnosis (Cohort 1).
✓. ≥6 years at the time of HLH diagnosis (Cohort 2-3).
✓. Treatment naïve or relapsed/refractory (Cohorts 1 and 2).
✓. Treatment naïve or early refractory (Cohort 3).
✓. Participant with sHLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria.
✓. Cohort A: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH.
✓. Cohort B: Adults with newly diagnosed, treatment-naïve, non-malignancy-associated sHLH.
✓. Cohort B: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index.
Exclusion criteria
✕. Known or previous treatment for primary HLH
✕. Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
What they're measuring
1
Part 1: Number of Participant with Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and tolerability]
Timeframe: Up to Week 12
2
Part 2 (Cohort A): 56-day Survival Rate in Participants with mHLH and Have Lymphoma as the Cancer Trigger