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

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

6 Years

Maximum Age

N/A

Key Inclusion Criteria:

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)
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.
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.
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

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