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Clinical Trials in the UK / NCT05416307
Recruiting Phase 2/3

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

NCT05416307 · tracked via the Priya Life Science UK tracker
Sponsor
Electra Therapeutics Inc.
Phase
Phase 2/3
Started
2022-05-19
Last updated
2026-05-26

Condition(s) studied

Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Investigational drug(s) / intervention(s)

ELA026

ELA026: Multiple doses of ELA026

Study 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

Sex
ALL
Min age
6 Years
Max age
Healthy volunteers
No
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. Known or previous treatment for primary HLH 2. Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study 3. Unknown trigger for sHLH 4. Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH 5. Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days of the first dose of ELA026. 6. Ongoing administration of any therapies used to treat HLH (excluding dexamethasone) 7. Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening Key Exclusion Criteria for Part 2: 1. Refractory sHLH (except for the safety lead-in cohort for 6-12 year olds in Cohort B). 2. Known or suspected primary or hereditary HLH. 3. Severe organ dysfunction. 4. Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures. 5. End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH. 6. Allogeneic hemopoietic stem cell transplant within 100 days prior to the first dose of ELA026.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
University of Alabama at Birmingham School of Medicine Birmingham Alabama Recruiting
Phoenix Children's Hospital Phoenix Arizona Active Not Recruiting
University of California, Los Angeles Los Angeles California Active Not Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia Recruiting
Johns Hopkins All Children's Hospital St. Petersburg Florida Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics Atlanta Georgia Recruiting
Emory University Atlanta Georgia Recruiting
National Institute of Allergy and Infectious Diseases (NIAID) Rockville Maryland Recruiting
Columbia University New York New York Recruiting
Cornell University New York New York Recruiting
Hackensack University Medical Center New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Cleveland Clinic Main Campus Cleveland Ohio Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Texas Children's Hospital Houston Texas Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting
Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location Seattle Washington Recruiting
Medizinische Universität Innsbruck Innsbruck Austria Withdrawn
Medical University of Vienna Vienna Austria Completed
Universitätsklinikum Jena Jena Thuringia Recruiting
Schwarzwald-Baar Klinikum Villingen-Schwenningen Villingen-Schwenningen Germany Recruiting
Azienda Ospedaliero Universitaria Meyer Florence Italy Recruiting
IRCCS Istituto Giannina Gaslini Genova Italy Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milan Italy Completed
Fondazione IRCCS San Gerardo dei Tintori (Ospedale San Gerardo) Monza Italy Recruiting
Azienda Ospedale Università di Padova Padova Italy Recruiting
Bambino Gesu' Roma Roma Italy Withdrawn
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Materno-Infantile Burlo Garofolo Trieste Italy Recruiting
Amsterdam Universitair Medische Centra - Locatie Academisch Medisch Centrum Amsterdam Noord-Holland - NET Recruiting
Radboud Universitair Medisch Centrum Nijmegen Netherlands Recruiting
Erasmus UMC Rotterdam Netherlands Active Not Recruiting
Wilhelmina Kinderziekenhuis Utrecht Netherlands Recruiting
Clinica Universidad de Navarra - Madrid Madrid Madrid - SPA Recruiting
Clinica Universidad de Navarra - Pamplona Pamplona Navarre - SPA Recruiting
Hospital Universitario Virgen del Rocio Seville Sevilla - SPA Recruiting
Hospital Universitari i Politecnic La Fe Valencia Valencia - SPA Recruiting
Hospital 12 de Octubre, Madrid Madrid Spain Withdrawn
Hospital Ramon y Cajal Madrid Spain Completed
Hospital La Fe Valencia Valencia Spain Withdrawn

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05416307 on ClinicalTrials.gov ↗ ← All trials in the UK