Texas Children's Cancer and Hematology Center Evaluation of the Safety and Efficacy of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis 

Diseases

The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with secondary hemophagocytic lymphohistiocytosis.

Description

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).

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (child, adult, older adult)
• Sexes Eligible for Study: All
• Treatment naïve or relapsed refractory HLH. Participant is hospitalized with HLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria

Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov