A Multipart, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Contact:

NCT Number:

Protocol:

ACYY0125

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II/III

This study is testing an investigational drug called ELA026 in people who have a rare and serious immune condition called secondary hemophagocytic lymphohistiocytosis (sHLH). Investigational means that it is not approved by the United States Food and Drug Administration (FDA). sHLH causes the immune system to become overactive, leading to inflammation and damage to organs. ELA026 is designed to target specific immune cells that may contribute to the inflammation seen in sHLH. The study will also use dexamethasone, an FDA-approved steroid commonly used to help control inflammation. In this study, everyone who joins will receive ELA026, and there is no comparison or placebo group. The goal is to better understand how ERLA026 affects the immune system in people who have not previously received treatment for sHLH.

Are you Eligible? (Inclusion Criteria)

  • age greater than 18 years old - a diagnosis of secondary HLH (sHLH) or HLH related to cancer (mHLH) - no prior treatment for HLH, except for steroids such as glucocorticoids

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032