Secondary Hemophagocytic Lymphohistiocytosis (sHLH)Phase 2/3NCT05416307
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
A Phase 2/3 study testing ELA026 in people with Secondary Hemophagocytic Lymphohistiocytosis (sHLH), run by Electra Therapeutics Inc. at 42 sites in 7 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
- What is being tested?
- ELA026
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 42 sitesin 7 countries
- Study dates
- 19 May 2022to Mar 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥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.
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- 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 join
- 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
- Unknown trigger for sHLH
- Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
- 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)
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- Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening
- 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.
- Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures.
- End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH.
- Allogeneic hemopoietic stem cell transplant within 30 days prior to enrollment.
Trial locations and contacts
42 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
42 sites in 7 countries
United States19 sites, 17 recruiting
- Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, 30322
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, 35233
- Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Completed
University of California, Los Angeles
Los Angeles, California, 90095
- Recruiting
Columbia University
New York, New York, 10032
- Recruiting
Cornell University
New York, New York, 10065
- Recruiting
Hackensack University Medical Center
New York, New York, 10065
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Completed
Phoenix Children's Hospital
Phoenix, Arizona, 85016
- Recruiting
National Institute of Allergy and Infectious Diseases (NIAID)
Rockville, Maryland, 20892
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location
Seattle, Washington, 98109
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Italy7 sites, 5 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Meyer
Florence, 50139
- Recruiting
IRCCS Istituto Giannina Gaslini
Genova, 16147
- Completed
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori (Ospedale San Gerardo)
Monza, 20900
- Recruiting
Azienda Ospedale Università di Padova
Padova, 35128
- Withdrawn
Bambino Gesu' Roma
Roma
- Recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Materno-Infantile Burlo Garofolo
Trieste, 34137
Spain7 sites, 4 recruiting
- Recruiting
Clinica Universidad de Navarra - Madrid
Madrid, Madrid - SPA, 28027
- Withdrawn
Hospital 12 de Octubre, Madrid
Madrid
- Completed
Hospital Ramon y Cajal
Madrid
- Recruiting
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre - SPA, 31008
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, Sevilla - SPA, 41013
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Valencia - SPA, 46026
- Withdrawn
Hospital La Fe Valencia
Valencia
Netherlands4 sites, 3 recruiting
- Recruiting
Amsterdam Universitair Medische Centra - Locatie Academisch Medisch Centrum
Amsterdam, Noord-Holland - NET, 1105 AZ
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
- Active, not recruiting
Erasmus UMC
Rotterdam
- Recruiting
Wilhelmina Kinderziekenhuis
Utrecht, 3584 EA
Austria2 sites
- Withdrawn
Medizinische Universität Innsbruck
Innsbruck
- Completed
Medical University of Vienna
Vienna
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07747
- Recruiting
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, 78052
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals NHS Foundation Trust
London, England - UK, NW1 2PG
About this study
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)
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.
Read the detailed description
This study consists of two parts: Phase 1b (Part 1) and Phase 2/3 (Part 2).
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 newly diagnosed TN adult and pediatric sHLH participants. All participants are diagnosed with HLH-2004 criteria unless indicated. Cohort A (primary cohort) will enroll newly diagnosed 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 newly diagnosed TN mHLH diagnosed by biomarker criteria but not meeting HLH-2004 diagnostic criteria; and 6 to 17 year old participants with newly diagnosed 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.
- Being tested
- ELA026
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELA026Drug
Multiple doses of ELA026
| Study group | Role | What they receive |
|---|---|---|
| Part 1 ELA026 | Experimental | 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. Receives: Drug: ELA026 |
| Part 2 ELA026 | Experimental | 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. Receives: Drug: ELA026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participant with Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and tolerability]
Incidence of adverse events (AEs) including dose-limiting toxicities (DLTs), serious adverse events (SAEs), deaths, AEs leading to withdrawal from study
Measured: Up to Week 12
Part 2 (Cohort A): 56-day Survival Rate in Participants with mHLH and Have Lymphoma as the Cancer Trigger
Measured: 56 days
Secondary outcomes (3)
Number of Participants Achieving Early Survival (Cohort A)
Measured: up to 90 days
Number of Participants Achieving HLH Disease Response by Day 29 (Cohort A)
HLH disease response includes achievement of CR, mCR, PR, or HI.
Measured: Up to Day 29
Number of Participants with TEAEs (Cohort A)
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start19 May 2022
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Hemophagocytic Lymphohistiocytosis (sHLH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Electra Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Electra Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416307
- Sponsor's protocol ID
- ELA026-CP002
- Status last verified
- Oct 2026
- First submitted
- 6 Jun 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05416307
- Acronym / sponsor ID
- ELA026-CP002
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Electra Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2022 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of two parts: Phase 1b (Part 1) and Phase 2/3 (Part 2).
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 newly diagnosed TN adult and pediatric sHLH participants. All participants are diagnosed with HLH-2004 criteria unless indicated. Cohort A (primary cohort) will enroll newly diagnosed 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 newly diagnosed TN mHLH diagnosed by biomarker criteria but not meeting HLH-2004 diagnostic criteria; and 6 to 17 year old participants with newly diagnosed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 ELA026 | Experimental | Drug: ELA026Cohort 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. |
| Part 2 ELA026 | Experimental | Drug: ELA026Cohort 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- ≥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.
Key exclusion criteria (13 listed)
- 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
- Unknown trigger for sHLH
- Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
- Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days of the first dose of ELA026.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELA026Multiple doses of ELA026 | Drug | Part 1 ELA026, Part 2 ELA026 |
Primary outcome
Part 1: Number of Participant with Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and tolerability]
Time frame: Up to Week 12
Incidence of adverse events (AEs) including dose-limiting toxicities (DLTs), serious adverse events (SAEs), deaths, AEs leading to withdrawal from study
Part 2 (Cohort A): 56-day Survival Rate in Participants with mHLH and Have Lymphoma as the Cancer Trigger
Time frame: 56 days
3 secondary outcomes
Number of Participants Achieving Early Survival (Cohort A)
Time frame: up to 90 days
Number of Participants Achieving HLH Disease Response by Day 29 (Cohort A)
Time frame: Up to Day 29
Number of Participants with TEAEs (Cohort A)
Time frame: Up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Not yet recruitingPhase 3
Efficacy of Short Course of Intravenous Dexamethasone and Intravenous Immunoglobulin Therapy in Infection-Related Secondary Hemophagocytic Lymphohistiocytosis (isHLH)
Hemophagocytic Lymphohistiocytosis (HLH), Secondary Hemophagocytic Lymphohistiocytosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Electra Therapeutics Inc.
42 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ELA026 in people with Secondary Hemophagocytic Lymphohistiocytosis (sHLH), run by Electra Therapeutics Inc. at 42 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Italy, Spain, Netherlands, Austria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials (Please email, clinicaltrials@electra-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participant with Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and tolerability] (time frame: Up to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.