RecruitingPhase 1NCT07083960

OM336 in Autoimmune Cytopenias

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias


Sponsor

Ouro Medicines

Enrollment

32 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • Active autoimmune cytopenia
  • Relapsed/refractory after ≥1 prior treatment
  • Body weight ≥ 55 kg
  • Willing to comply with and study requirements and procedures

Exclusion Criteria4

  • Previous treatment with a BCMA-targeted therapy
  • Clinically significant infection within 3 months of screening
  • Major surgery or splenectomy within 3 months of screening or planned during the study
  • Pregnant or breastfeeding

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Interventions

DRUGOM336

OM336 is an engineered bispecific antibody directed against BCMA and CD3


Locations(3)

The Canberra Hospital

Canberra, Australian Capital Territory, Australia

Liverpool Hospital

Sydney, New South Wales, Australia

Icon Cancer Center South Brisbane

Brisbane, Queensland, Australia

View Full Details on ClinicalTrials.gov

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NCT07083960


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