RecruitingPhase 2Phase 3NCT05416307

Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

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


Sponsor

Electra Therapeutics Inc.

Enrollment

156 participants

Start Date

May 19, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ELA026 for people with secondary hemophagocytic lymphohistiocytosis (shlh). The study is currently recruiting participants at 41 locations. People eligible for this study include aged 6 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGELA026

Multiple doses of ELA026


Locations(41)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

University of California, Los Angeles

Los Angeles, California, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

National Institute of Allergy and Infectious Diseases (NIAID)

Rockville, Maryland, United States

Columbia University

New York, New York, United States

Cornell University

New York, New York, United States

Hackensack University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location

Seattle, Washington, United States

Medizinische Universität Innsbruck

Innsbruck, Austria

Medical University of Vienna

Vienna, Austria

Universitätsklinikum Jena

Jena, Thuringia, Germany

Schwarzwald-Baar Klinikum Villingen-Schwenningen

Villingen-Schwenningen, Germany

Azienda Ospedaliero Universitaria Meyer

Florence, Italy

IRCCS Istituto Giannina Gaslini

Genova, Italy

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori (Ospedale San Gerardo)

Monza, Italy

Azienda Ospedale Università di Padova

Padova, Italy

Bambino Gesu' Roma

Roma, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Materno-Infantile Burlo Garofolo

Trieste, Italy

Amsterdam Universitair Medische Centra - Locatie Academisch Medisch Centrum

Amsterdam, Noord-Holland - NET, Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Erasmus UMC

Rotterdam, Netherlands

Wilhelmina Kinderziekenhuis

Utrecht, Netherlands

Clinica Universidad de Navarra - Madrid

Madrid, Madrid - SPA, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre - SPA, Spain

Hospital Universitario Virgen del Rocio

Seville, Sevilla - SPA, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Valencia - SPA, Spain

Hospital 12 de Octubre, Madrid

Madrid, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital La Fe Valencia

Valencia, Spain

University College London Hospitals NHS Foundation Trust

London, England - UK, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05416307