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Recruiting Phase 1 NCT07083960

NCT07083960 OM336 in Autoimmune Cytopenias

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Clinical Trial Summary
NCT ID NCT07083960
Status Recruiting
Phase Phase 1
Sponsor Ouro Medicines
Condition AIHA - Warm Autoimmune Hemolytic Anemia
Study Type INTERVENTIONAL
Enrollment 32 participants
Start Date 2025-08-01
Primary Completion 2026-12

Trial Parameters

Condition AIHA - Warm Autoimmune Hemolytic Anemia
Sponsor Ouro Medicines
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 32
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-08-01
Completion 2026-12
Interventions
OM336

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Brief Summary

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

Eligibility Criteria

Key Inclusion Criteria: * Active autoimmune cytopenia * Relapsed/refractory after ≥1 prior treatment * Body weight ≥ 55 kg * Willing to comply with and study requirements and procedures Key Exclusion Criteria: * 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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