An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
OM336 is an engineered bispecific antibody directed against BCMA and CD3
The Canberra Hospital
Canberra, Australian Capital Territory, Australia
RECRUITINGLiverpool Hospital
Sydney, New South Wales, Australia
RECRUITINGIcon Cancer Center South Brisbane
Brisbane, Queensland, Australia
RECRUITINGSafety and Tolerability
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: 12 weeks
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 52 weeks
To assess the pharmacokinetics (PK) of OM336
Serum concentrations of OM336
Time frame: 12 weeks
Detection of anti-drug antibodies
Detection of anti-drug antibodies
Time frame: 12 weeks
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