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Taking people in United StatesPhase 2/3

ELA026 for secondary hemophagocytic lymphohistiocytosis, a severe immune overactivation condition

Tests ELA026 in people with secondary hemophagocytic lymphohistiocytosis.

Key facts

Who runs it
Electra Therapeutics Inc.
Where
Atlanta, Birmingham, Cleveland, Dallas, Houston, Los Angeles, New York, Philadelphia, Phoenix, Rockville, Salt Lake City, Seattle, St. Petersburg, and Washington D.C., United StatesSee the 19 sitesAlso in 6 other countries, 23 sites
Trial code
Registry title
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Status
Recruiting
Phase
Phase 2/3
People taking part
156 people, planned
Started
19 May 2022
Expected to end
Mar 2030
Type of study
Interventional, 2 groups
Treatments tested
  • ELA026
Record updated
13 October 2026

Who can take part

Age
6 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • ≥12 years at the time of HLH diagnosis (Cohort 1)
  • ≥6 years at the time of HLH diagnosis (Cohort 2-3)
  • Treatment naïve or relapsed/refractory (Cohorts 1 and 2)
  • Treatment naïve or early refractory (Cohort 3)
  • Participant with sHLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria
  • Cohort A: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH
  • Cohort B: Adults with newly diagnosed, treatment-naïve, non-malignancy-associated sHLH
  • Cohort B: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index
  • Cohort B: 13 to 17 years olds with newly diagnosed, treatment-naïve sHLH
  • Cohort B: 6 to 12 year olds, with refractory sHLH (safety lead-in cohort)
  • Cohort B: 6 to 12 year olds, with newly diagnosed, treatment-naïve sHLH (after completion of safety lead-in cohort)

Who cannot take part

  • Known or previous treatment for primary HLH
  • Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
  • Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days of the first dose of ELA026
  • Ongoing administration of any therapies used to treat HLH (excluding dexamethasone)
  • Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening
  • Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures
  • Allogeneic hemopoietic stem cell transplant within 30 days prior to enrollment
  • Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
  • End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
  • Unknown trigger for sHLH
  • Refractory sHLH (except for the safety lead-in cohort for 6-12 year olds in Cohort B)
  • Known or suspected primary or hereditary HLH
  • Severe organ dysfunction

Where in United States

Also in 6 other countries, 23 sites

  • Children's Healthcare of Atlanta Center for Advanced PediatricsAtlanta, United StatesContact: Clinical TrialsTaking people
  • Emory UniversityAtlanta, United StatesContact: Clinical TrialsTaking people
  • University of Alabama at Birmingham School of MedicineBirmingham, United StatesContact: Clinical TrialsTaking people
  • Cleveland Clinic - Main CampusCleveland, United StatesContact: Clinical TrialsTaking people
  • University of Texas Southwestern Medical CenterDallas, United StatesContact: Clinical TrialsTaking people
  • Texas Children's HospitalHouston, United StatesContact: Clinical TrialsTaking people
  • University of Texas - MD Anderson Cancer CenterHouston, United StatesContact: Clinical TrialsTaking people
  • University of California, Los AngelesLos Angeles, United StatesContact: Clinical TrialsNo longer taking part
  • Columbia UniversityNew York, United StatesContact: Clinical TrialsTaking people
  • Cornell UniversityNew York, United StatesContact: Clinical TrialsTaking people
  • Hackensack University Medical CenterNew York, United StatesContact: Clinical TrialsTaking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesContact: Clinical TrialsTaking people
  • Thomas Jefferson UniversityPhiladelphia, United StatesContact: Clinical TrialsTaking people
  • Phoenix Children s HospitalPhoenix, United StatesContact: Clinical TrialsNo longer taking part
  • National Institute of Allergy and Infectious Diseases (NIAID)Rockville, United StatesContact: Clinical TrialsTaking people
  • Huntsman Cancer InstituteSalt Lake City, United StatesContact: Clinical TrialsTaking people
  • Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) LocationSeattle, United StatesContact: Clinical TrialsTaking people
  • Johns Hopkins All Children's HospitalSt. Petersburg, United StatesContact: Clinical TrialsTaking people
  • MedStar Georgetown University HospitalWashington D.C., United StatesContact: Clinical TrialsTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Part 1 ELA026Treatment being tested

    Cohort 1: Single dose escalation up to 3.0 mg/kg IV or SC. Cohort 2: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Day 2 - 4, followed by weekly maintenance doses of 1 mg/kg IV/SC from Day 8 to Day 81. Cohort 3: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Days 2 - 4, followed by twice weekly maintenance doses of 0.5 mg/kg IV/SC from Day 8 to Day 81.

    Treatment: ELA026

  • Part 2 ELA026Treatment being tested

    Cohort A and Cohort B: priming dose: 0.1 mg/kg IV/SC on Day 1; loading dose 0.3 mg/kg IV/SC on Days 2 - 4, followed by twice weekly maintenance doses of 0.5 mg/kg (IV/SC) from Day 8 to Day 81.

    Treatment: ELA026

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multipart, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Plain-language title
ELA026 for secondary hemophagocytic lymphohistiocytosis, a severe immune overactivation conditionGenerated from the registry record. The registry title is the official one.
Record updated
13 October 2026