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New drug targets deadly immune overreaction in rare disease

NCT ID NCT05416307

Disease control Sponsor: Electra Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, ELA026, for people with secondary hemophagocytic lymphohistiocytosis (sHLH), a rare and life-threatening condition where the immune system becomes dangerously overactive. The drug aims to calm this overreaction by removing certain immune cells. The trial will check if ELA026 is safe and helps people survive longer, involving about 156 participants aged 6 and older.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acquired hemophagocytic lymphohistiocytosis associated with malignant disease secondary hemophagocytic lymphohistiocytosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Secondary hemophagocytic lymphohistiocytosis (SHLH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam Universitair Medische Centra - Locatie Academisch Medisch Centrum

    RECRUITING

    Amsterdam, Noord-Holland - NET, 1105 AZ, Netherlands

  • Azienda Ospedale Università di Padova

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliero Universitaria Meyer

    RECRUITING

    Florence, 50139, Italy

  • Bambino Gesu' Roma

    WITHDRAWN

    Roma, Italy

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Cleveland Clinic Main Campus

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, Madrid - SPA, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona

    RECRUITING

    Pamplona, Navarre - SPA, 31008, Spain

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Cornell University

    RECRUITING

    New York, New York, 10065, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Erasmus UMC

    ACTIVE_NOT_RECRUITING

    Rotterdam, Netherlands

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    COMPLETED

    Milan, Italy

  • Fondazione IRCCS San Gerardo dei Tintori (Ospedale San Gerardo)

    RECRUITING

    Monza, 20900, Italy

  • Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location

    RECRUITING

    Seattle, Washington, 98109, United States

  • Hackensack University Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • Hospital 12 de Octubre, Madrid

    WITHDRAWN

    Madrid, Spain

  • Hospital La Fe Valencia

    WITHDRAWN

    Valencia, Spain

  • Hospital Ramon y Cajal

    COMPLETED

    Madrid, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, Valencia - SPA, 46026, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Sevilla - SPA, 41013, Spain

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IRCCS Istituto Giannina Gaslini

    RECRUITING

    Genova, 16147, Italy

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Materno-Infantile Burlo Garofolo

    RECRUITING

    Trieste, 34137, Italy

  • Johns Hopkins All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • MedStar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Medical University of Vienna

    COMPLETED

    Vienna, Austria

  • Medizinische Universität Innsbruck

    WITHDRAWN

    Innsbruck, Austria

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • National Institute of Allergy and Infectious Diseases (NIAID)

    RECRUITING

    Rockville, Maryland, 20892, United States

  • Phoenix Children's Hospital

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85016, United States

  • Radboud Universitair Medisch Centrum

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen

    RECRUITING

    Villingen-Schwenningen, 78052, Germany

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University College London Hospitals NHS Foundation Trust

    RECRUITING

    London, England - UK, NW1 2PG, United Kingdom

  • University of Alabama at Birmingham School of Medicine

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California, Los Angeles

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90095, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Universitätsklinikum Jena

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • Wilhelmina Kinderziekenhuis

    RECRUITING

    Utrecht, 3584 EA, Netherlands