AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
Conditions
Brief summary
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Detailed description
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.
Interventions
DRUGOM336
OM336 is an engineered bispecific antibody directed against BCMA and CD3
Sponsors
Ouro Medicines
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 12 weeks | Incidence and severity of treatment emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 52 weeks | Incidence and severity of treatment-emergent adverse events (TEAEs) |
| To assess the pharmacokinetics (PK) of OM336 | 12 weeks | Serum concentrations of OM336 |
| Detection of anti-drug antibodies | 12 weeks | Detection of anti-drug antibodies |
Countries
Australia
Contacts
Primary ContactStudy Sponsor
Outcome results
None listed