Summary

Eligibility
for people ages 6 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce 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 secondary hemophagocytic lymphohistiocytosis.

Official Title

A Phase 1b, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Details

This study is an open-label, single arm, multicenter interventional study, comprised of 4 cohorts; a dose escalating cohort (cohort 1) followed by 3 fixed dose cohorts (Cohorts 2-4). Newly diagnosed and previously treated participants with secondary hemophagocytic lymphohistiocytosis will be enrolled and treated over 12-weeks. Secondary hemophagocytic lymphohistiocytosis is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (m-HLH), infection, or autoimmune disease).

Keywords

Secondary Hemophagocytic Lymphohistiocytosis (sHLH), Neoplasm Metastasis, Hemophagocytic Lymphohistiocytosis, ELA026

Eligibility

You can join if…

Open to people ages 6 years and up

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

    US only: ≥12 years at the time of HLH diagnosis (Cohort 1-4) and 6 to <12 years at the time of HLH diagnosis (Cohorts 2-4)

  2. Treatment naïve OR;
  3. Relapsed refractory HLH. Participant is hospitalized with HLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria

You CAN'T join if...

  1. Known or previous treatment for primary HLH
  2. Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
  3. Hemopoietic Stem Cell Transplant (HSCT) within 100 days of the first dose of ELA026.
  4. All countries except US: Treatment with CAR T-Cell therapy within 3 months of the first dose of ELA026.

    US Only: Treatment with CAR T-Cell therapy allowed within 3 months of first dose.

  5. Ongoing administration of any investigational treatment (excluding dexamethasone) within 14 days prior to Screening or 5 drug half-lives, whichever is shorter
  6. Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening

Locations

  • University of California, Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • Phoenix Children's Hospital not yet accepting patients
    Phoenix Arizona 85016 United States
  • MD Anderson accepting new patients
    Houston Texas 77030 United States
  • Texas Children's Hospital accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Electra Therapeutics Inc.
Links
Sign up for this study
ID
NCT05416307
Phase
Phase 1 Hemophagocytic Lymphohistiocytosis Research Study
Study Type
Interventional
Participants
Expecting 24 study participants
Last Updated