NCT05416307 · Electra Therapeutics Inc.
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
What this 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).
View original scientific description
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).
Interventions
DRUG
ELA026
Multiple doses of ELA026
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 100 days prior to the first dose of ELA026.
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Los Angeles, California
- Washington D.C., District of Columbia
- St. Petersburg, Florida
- Atlanta, Georgia
- Rockville, Maryland
- New York, New York
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Dallas, Texas
- Houston, Texas
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 13, 2026 · Source of record for eligibility and locations