Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
NCT ID: NCT05416307
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
156 participants
INTERVENTIONAL
2022-05-19
2029-06-30
Brief Summary
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Detailed Description
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Part 1 is designed to evaluate the safety, efficacy, pharmacodynamics, and pharmacokinetics of ELA026 in pediatric and adult participants with treatment-naïve (TN) and relapsed/refractory sHLH. The main objectives of Part 1 are to determine the safety of ELA026 administered intravenously (IV) and subcutaneously (SC) to participants with sHLH and to identify the recommended Phase 3 dose and schedule for ELA026. Participants will be enrolled into a dose-escalating cohort (Cohort 1) followed by two fixed dose cohorts (Cohorts 2-3) treated over 12-weeks.
Part 2 (SURPASS) is designed as an open-label, single-arm, multicenter, historical control registrational study to evaluate ELA026 in TN adult and pediatric sHLH participants. All participants are diagnosed with HLH-2004 criteria unless indicated. Cohort A (primary cohort) will enroll TN participants ≥18 years old with mHLH. Cohort B (exploratory cohort) will enroll participants including ≥18 years old participants with TN sHLH not triggered by malignancy; ≥18 years old participants with TN mHLH diagnosed by biomarker criteria but not meeting HLH-2004 diagnostic criteria; and 6 to 17 year old participants with TN sHLH (due to any trigger). For 6 to 12 year old participants, there is a safety lead-in cohort with refractory sHLH.
Part 1 is closed to recruitment and Part 2 is recruiting for eligible participants.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 ELA026
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.
ELA026
Multiple doses of ELA026
Part 2 ELA026
Cohort A and Cohort B: priming dose: 0.1 mg/kg IV on Day 1; loading dose 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.
ELA026
Multiple doses of ELA026
Interventions
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ELA026
Multiple doses of ELA026
Eligibility Criteria
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Inclusion Criteria
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.
1. Cohort A: Adults with treatment-naïve, malignancy-associated sHLH.
2. Cohort B: Adults with treatment-naïve, non-malignancy-associated sHLH.
3. Cohort B: Adults with treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index.
4. Cohort B: 13 to 17 years olds with 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 treatment-naïve sHLH (after completion of safety lead-in cohort).
Exclusion Criteria
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
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.
6 Years
ALL
No
Sponsors
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Electra Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Electra Therapeutics Inc.
Locations
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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
Emory University
Atlanta, Georgia, United States
Columbia University
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 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
Medizinische Universität Innsbruck
Innsbruck, , Austria
Medical University of Vienna
Vienna, , Austria
Universitätsklinikum Jena
Jena, Thuringia, Germany
Azienda Ospedaliero Universitaria Meyer
Florence, , Italy
IRCCS Istituto Giannina Gaslini
Genova, , Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, , Italy
Bambino Gesu' Roma
Roma, , Italy
Amsterdam Universitair Medische Centra - Locatie Academisch Medisch Centrum
Amsterdam, Noord-Holland - NET, 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
Countries
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Central Contacts
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Other Identifiers
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ELA026-CP002
Identifier Type: -
Identifier Source: org_study_id