Actively Recruiting
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Led by Electra Therapeutics Inc. · Updated on 2026-05-01
156
Participants Needed
40
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 12 years or older at diagnosis for Part 1 Cohort 1
- 6 years or older at diagnosis for Part 1 Cohorts 2 and 3
- Treatment-naive or relapsed/refractory status for Part 1 Cohorts 1 and 2
- Treatment-naive or early refractory for Part 1 Cohort 3
- Diagnosis of sHLH confirmed by meeting 5 of 8 HLH-2004 criteria
- Adults with newly diagnosed, treatment-naive malignancy-associated sHLH for Part 2 Cohort A
- Adults with newly diagnosed, treatment-naive non-malignancy-associated sHLH for Part 2 Cohort B
- Adults with newly diagnosed, treatment-naive malignancy-associated sHLH diagnosed by biomarker criteria for Part 2 Cohort B
- Participants aged 13 to 17 years with newly diagnosed, treatment-naive sHLH for Part 2 Cohort B
- Participants aged 6 to 12 years with refractory sHLH in safety lead-in cohort for Part 2 Cohort B
- Participants aged 6 to 12 years with newly diagnosed, treatment-naive sHLH after safety lead-in for Part 2 Cohort B
You will not qualify if you...
- Previous or known treatment for primary HLH
- Any significant uncontrolled medical condition that contraindicates study participation
- Unknown trigger for sHLH
- Active relapsed/refractory malignancy without suitable therapies
- Allogeneic hematopoietic stem cell transplant within 100 days before first ELA026 dose
- Ongoing treatment for HLH except dexamethasone
- Receipt of live or attenuated vaccine within 6 weeks or BCG vaccine within 12 weeks before screening
- Refractory sHLH except safety lead-in 6-12 year olds in Part 2 Cohort B
- Known or suspected primary or hereditary HLH
- Severe organ dysfunction
- End-stage malignancy without suitable therapies
- Any other significant uncontrolled medical condition preventing study procedures completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Active, Not Recruiting
3
University of California, Los Angeles
Los Angeles, California, United States, 90095
Active, Not Recruiting
4
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
5
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
6
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
National Institute of Allergy and Infectious Diseases (NIAID)
Rockville, Maryland, United States, 20892
Actively Recruiting
9
Columbia University
New York, New York, United States, 10032
Actively Recruiting
10
Cornell University
New York, New York, United States, 10065
Actively Recruiting
11
Hackensack University Medical Center
New York, New York, United States, 10065
Actively Recruiting
12
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
13
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
14
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
15
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
17
Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location
Seattle, Washington, United States, 98109
Actively Recruiting
18
Medizinische Universität Innsbruck
Innsbruck, Austria
Withdrawn
19
Medical University of Vienna
Vienna, Austria
Completed
20
Universitätsklinikum Jena
Jena, Thuringia, Germany, 07747
Actively Recruiting
21
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany, 78052
Actively Recruiting
22
Azienda Ospedaliero Universitaria Meyer
Florence, Italy, 50139
Actively Recruiting
23
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Actively Recruiting
24
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy
Completed
25
Fondazione IRCCS San Gerardo dei Tintori (Ospedale San Gerardo)
Monza, Italy, 20900
Actively Recruiting
26
Azienda Ospedale Università di Padova
Padova, Italy, 35128
Actively Recruiting
27
Bambino Gesu' Roma
Roma, Italy
Withdrawn
28
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Materno-Infantile Burlo Garofolo
Trieste, Italy, 34137
Actively Recruiting
29
Amsterdam Universitair Medische Centra - Locatie Academisch Medisch Centrum
Amsterdam, Noord-Holland - NET, Netherlands, 1105 AZ
Actively Recruiting
30
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
31
Erasmus UMC
Rotterdam, Netherlands
Active, Not Recruiting
32
Wilhelmina Kinderziekenhuis
Utrecht, Netherlands, 3584 EA
Actively Recruiting
33
Clinica Universidad de Navarra - Madrid
Madrid, Madrid - SPA, Spain, 28027
Actively Recruiting
34
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre - SPA, Spain, 31008
Actively Recruiting
35
Hospital Universitario Virgen del Rocio
Seville, Sevilla - SPA, Spain, 41013
Actively Recruiting
36
Hospital Universitari i Politecnic La Fe
Valencia, Valencia - SPA, Spain, 46026
Actively Recruiting
37
Hospital 12 de Octubre, Madrid
Madrid, Spain
Withdrawn
38
Hospital Ramon y Cajal
Madrid, Spain
Completed
39
Hospital La Fe Valencia
Valencia, Spain
Withdrawn
40
University College London Hospitals NHS Foundation Trust
London, England - UK, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
C
Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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