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

Sponsor

Electra Therapeutics Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05416307

Collaborator

(none)

Enrollment

Locations

Arm

14.4

Anticipated Duration (Months)

2.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 adult and adolescent patients 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 adult and adolescent patients 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

Study Type:

Interventional

Anticipated 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 Adults and Adolescents With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Actual Study Start Date :

May 19, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Primary Outcome Measures

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

Best Response to Treatment [By week 4]
Achievement of a complete response (CR), modified complete response (mCR), partial response (PR) or HLH improvement
Plasma concentrations of ELA026 [Baseline to week 12]
Change from baseline in monocyte levels [Baseline to week 12]
Incidence of Anti-drug antibodies to ELA026 [Baseline to week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

≥12 years at the time of HLH diagnosis
Treatment naïve OR;
Relapsed refractory HLH. Participant is hospitalized with HLH confirmed criteria based on fulﬁlling 5 out of 8 HLH-2004 diagnostic criteria

Key Exclusion Criteria:

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
Hemopoietic Stem Cell Transplant (HSCT) within 100 days of the ﬁrst dose of ELA026.
Treatment with CAR T-Cell therapy within 3 months of the ﬁrst dose of ELA026
Ongoing administration of any investigational treatment (excluding dexamethasone) within 14 days prior to Screening or 5 drug half-lives, whichever is shorter
Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening

Contacts and Locations

Locations

	Site	City	Country
1	Medizinische Universität Innsbruck	Innsbruck	Austria
2	Medical University of Vienna	Vienna	Austria
3	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Milan	Italy
4	Bambino Gesu' Roma	Roma	Italy
5	Amsterdam UMC	Amsterdam	Netherlands
6	Erasmus UMC	Rotterdam	Netherlands
7	Hospital 12 de Octubre, Madrid	Madrid	Spain
8	Hospital Ramon y Cajal	Madrid	Spain
9	Hospital La Fe Valencia	Valencia	Spain
10	University College London Hospitals	London	United Kingdom

Sponsors and Collaborators

Electra Therapeutics Inc.

Investigators

Study Director: Medical Director, Electa Therapeutics Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Electra Therapeutics Inc.

ClinicalTrials.gov Identifier:

NCT05416307

Other Study ID Numbers:

ELA026-CP002

First Posted:

Jun 13, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Lymphohistiocytosis, Hemophagocytic

Study Results

No Results Posted as of Aug 16, 2022