About this trial
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Active autoimmune cytopenia
Relapsed/refractory after ≥1 prior treatment
Body weight ≥ 55 kg
Willing to comply with and study requirements and procedures
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
OM336
DrugOM336 is an engineered bispecific antibody directed against BCMA and CD3
Treatment groups
Trial outcomes
Primary outcomes
Safety and Tolerability
Incidence and severity of treatment emergent adverse events (TEAEs)
Secondary outcomes
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
To assess the pharmacokinetics (PK) of OM336
Serum concentrations of OM336
Detection of anti-drug antibodies
Detection of anti-drug antibodies
Sponsors and contacts
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