| 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
Eligibility Fast-Check
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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