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Evaluation of the Safety and Efficacy of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05416307
Recruitment Status : Recruiting
First Posted : June 13, 2022
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
Electra Therapeutics Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Secondary Hemophagocytic Lymphohistiocytosis (sHLH) Drug: ELA026 Phase 1

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 19, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ELA026

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

 Drug: ELA026
Single or multiple daily doses of ELA026


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] [ Time Frame: By week 12 ]
    Incidence of adverse events (AEs) including dose-limiting toxicities (DLTs), serious adverse events (SAEs), deaths, AEs leading to withdrawal from study


Secondary Outcome Measures :
  1. Best Response to Treatment [ Time Frame: By week 4 ]
    Achievement of a complete response (CR), modified complete response (mCR), partial response (PR) or HLH improvement

  2. Plasma concentrations of ELA026 [ Time Frame: Baseline to week 12 ]
  3. Change from baseline in monocyte levels [ Time Frame: Baseline to week 12 ]
  4. Incidence of Anti-drug antibodies to ELA026 [ Time Frame: Baseline to week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  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

    Key Exclusion Criteria:

  4. Known or previous treatment for primary HLH
  5. Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
  6. Hemopoietic Stem Cell Transplant (HSCT) within 100 days of the first dose of ELA026.

  7. 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.

  8. Ongoing administration of any investigational treatment (excluding dexamethasone) within 14 days prior to Screening or 5 drug half-lives, whichever is shorter
  9. Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05416307


Contacts
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Contact: Clinical Trials 650-466-8041 info@electra-therapeutics.com

Locations
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United States, Arizona
Phoenix Children's Hospital Not yet recruiting
Phoenix, Arizona, United States, 85016
United States, California
University of California, Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
United States, District of Columbia
MedStar Georgetown Recruiting
Washington, District of Columbia, United States, 20007
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria
Medical University of Vienna Recruiting
Vienna, Austria
Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Recruiting
Milan, Italy
Bambino Gesu' Roma Recruiting
Roma, Italy
Netherlands
Amsterdam UMC Recruiting
Amsterdam, Netherlands
Erasmus UMC Recruiting
Rotterdam, Netherlands
Spain
Hospital 12 de Octubre, Madrid Recruiting
Madrid, Spain
Hospital Ramon y Cajal Recruiting
Madrid, Spain
Hospital La Fe Valencia Recruiting
Valencia, Spain
United Kingdom
University College London Hospitals Recruiting
London, United Kingdom
Sponsors and Collaborators
Electra Therapeutics Inc.
Investigators
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Study Director: Medical Director Electa Therapeutics Inc.
More Information
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Responsible Party: Electra Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05416307    
Other Study ID Numbers: ELA026-CP002
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: October 19, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Lymphohistiocytosis, Hemophagocytic
Neoplastic Processes
Neoplasms
 Pathologic Processes
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases