Overview
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Description
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.
Eligibility
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