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

ConditionSecondary Hemophagocytic Lymphohistiocytosis (sHLH)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6+
SponsorElectra Therapeutics Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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).

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ELA026

    Drug

    Multiple doses of ELA026

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Part 1 ELA026Experimental treatment 1 intervention
Group B: Part 2 ELA026Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of Participant with Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and tolerability]

Incidence of adverse events (AEs) including dose-limiting toxicities (DLTs), serious adverse events (SAEs), deaths, AEs leading to withdrawal from study

Time frame
Up to Week 12
2

Part 2 (Cohort A): 56-day Survival Rate in Participants with mHLH and Have Lymphoma as the Cancer Trigger

Time frame
56 days

Secondary outcomes

1

Number of Participants Achieving Early Survival (Cohort A)

Time frame
up to 90 days
2

Number of Participants Achieving HLH Disease Response by Day 29 (Cohort A)

HLH disease response includes achievement of CR, mCR, PR, or HI.

Time frame
Up to Day 29
3

Number of Participants with TEAEs (Cohort A)

Time frame
Up to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Electra Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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