Status:
RECRUITING
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Lead Sponsor:
Electra Therapeutics Inc.
Conditions:
Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Eligibility:
All Genders
6+ years
Phase:
PHASE2
PHASE3
Brief 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 th...
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 adul...
Eligibility Criteria
Inclusion
- 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 treatment-naïve, malignancy-associated sHLH.
- Cohort B: Adults with treatment-naïve, non-malignancy-associated sHLH.
- Cohort B: Adults with treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index.
- Cohort B: 13 to 17 years olds with 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 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 100 days prior to the first dose of ELA026.
Exclusion
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT05416307
Start Date
May 19 2022
End Date
June 1 2029
Last Update
December 18 2025
Active Locations (30)
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1
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
University of California, Los Angeles
Los Angeles, California, United States, 90095
4
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007