What side effects are associated with this type of intervention?

Common treatments for Hemophagocytic Lymphohistiocytosis (HLH) often involve immunosuppressive therapies, such as corticosteroids, etoposide, and monoclonal antibodies like rituximab. Known side effects of these treatments can include increased risk of infections, cytopenias (reduction in blood cell counts), liver toxicity, and infusion-related reactions. Specifically, monoclonal antibodies targeting immune cells, such as ELA026, may cause infusion reactions, increased susceptibility to infections, and potential autoimmune complications due to their immunomodulatory effects.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for treatments of Hemophagocytic Lymphohistiocytosis (HLH) in the provided context. ELA026, a SIRP-directed monoclonal antibody, is designed to reduce myeloid and T cell activity, which is a novel approach. Generally, treatments for HLH have included immunosuppressive therapies, corticosteroids, and chemotherapy, but specific FDA-approved drugs similar to ELA026 are not detailed in the context.

What other types of research exist?

Promising novel alternatives to ELA026 for Hemophagocytic Lymphohistiocytosis patients include anti-tumor necrosis factor alpha (TNF-alpha) therapy, which has been used to attenuate hyperinflammatory states in conditions like X-linked lymphoproliferative disease. Additionally, therapies targeting interleukin pathways, such as IL-1 and IL-6 inhibitors, and other immune checkpoint inhibitors like TTI-621 (SIRPα-IgG1 Fc) are also being explored for their potential to modulate excessive immune activation in HLH.

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Monoclonal Antibodies

ELA026 for Hemophagocytic Lymphohistiocytosis

Phase 1

Recruiting

Research Sponsored by Electra Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All countries: ≥12 years at the time of HLH diagnosis (Cohort 1-4)

Relapsed refractory HLH. Participant is hospitalized with HLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria

Must not have

Known or previous treatment for primary HLH

Ongoing administration of any investigational treatment (excluding dexamethasone) within 14 days prior to Screening or 5 drug half-lives, whichever is shorter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up by week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ELA026, a medicine designed to reduce harmful inflammation, in patients with secondary hemophagocytic lymphohistiocytosis (HLH). The treatment aims to calm the overactive immune system by targeting specific cells causing the inflammation.

Who is the study for?

This trial is for people aged 12 and older diagnosed with secondary hemophagocytic lymphohistiocytosis (HLH), a severe immune activation condition. Participants can be treatment-naive or have relapsed/refractory HLH, must meet specific diagnostic criteria, and be hospitalized. Those with primary HLH, uncontrolled conditions, recent investigational treatments or stem cell transplants are excluded.

What is being tested?

The study tests ELA026, an antibody aimed at reducing inflammation caused by myeloid and T cells in patients with secondary HLH. It evaluates the safety and effectiveness of this drug as well as how it's processed by the body.

What are the potential side effects?

Potential side effects of ELA026 may include reactions related to immune suppression such as increased risk of infections. Specific side effects are not listed but generally could involve issues due to interaction with the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was 12 years or older when diagnosed with HLH.

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I have HLH and meet most of the HLH-2004 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated for HLH before.

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I haven't taken any experimental drugs recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ by week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~by week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and by week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]

Secondary study objectives

Best Response to Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ELA026Experimental Treatment1 Intervention

Cohort 1: Single dose escalation up to 3.0 mg/kg IV or SC Cohorts 2-4: dose, route, and frequency of administration (IV or SC) to be determined

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ELA026

2021

Completed Phase 1

~100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hemophagocytic Lymphohistiocytosis (HLH) focus on modulating the immune system to reduce excessive inflammation. ELA026, a SIRP-directed monoclonal antibody, exemplifies this approach by targeting and reducing the activity of myeloid and T cells, which are key drivers of the hyperinflammatory state in HLH. This mechanism is vital for HLH patients as it helps to control the overactive immune response, thereby decreasing inflammation and preventing severe tissue damage and organ failure, ultimately improving patient outcomes.

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