Skip to content
Bored Studies
RecruitingPhase 2/Phase 3

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

Electra Therapeutics Inc. · NCT05416307

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
156
US sites recruiting
17
Study start
May 19, 2022
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ELA026

Conditions: Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria for Part 1:

  • ≥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 Inclusion Criteria for Part 2:

  • 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).

Key Exclusion Criteria for Part 1:

  • 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)
  • 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:

  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Clinical Trials · Please email · clinicaltrials@electra-therapeutics.com
Open-label Study of ELA026 in Participants With Secondary… (NCT05416307) | Bored Studies