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

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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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
6 Years
Maximum Age
N/A

Key Inclusion Criteria:

  • ≥12 years at the time of HLH diagnosis (Cohort 1)
  • ≥6 years at the time of HLH diagnosis (Cohort 2-4)
  • Treatment naïve OR
  • Early refractory sHLH
  • Participant with sHLH 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
  • Unknown trigger for sHLH
  • Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
  • Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days of the first dose of ELA026.
  • Ongoing administration of any therapies used to treat HLH (excluding dexamethasone)
  • Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening

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Study Stats
Protocol No.
23-000313
Category
Other Cancer
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05416307
For detailed technical eligibility, visit ClinicalTrials.gov.