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Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

RecruitingPhase 2, Phase 3Ages 6 Years - anyAllElectra Therapeutics Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 30 days prior to enrollment.
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What it tests

  • ELA026
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Where

42 sites
University of Alabama at Birmingham School of Medicine
Birmingham, United States
Phoenix Children's Hospital
Phoenix, United States
University of California, Los Angeles
Los Angeles, United States
MedStar Georgetown University Hospital
Washington D.C., United States
Johns Hopkins All Children's Hospital
St. Petersburg, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, United States
Emory University
Atlanta, United States
National Institute of Allergy and Infectious Diseases (NIAID)
Rockville, United States

…and 34 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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