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Recruiting Phase 1 NCT07083960

OM336 in Autoimmune Cytopenias

Phase 1 – testing safety in a small group of people
Conditions: AIHA - Warm Autoimmune Hemolytic Anemia AIHA - Cold Autoimmune Hemolytic Anemia ITP - Immune Thrombocytopenia

Sponsor: Ouro Medicines

trial.available_in: БГ
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.
Who can participate
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
Locations 1
Australia (1)
The Canberra Hospital
Canberra , Australian Capital Territory
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.08.2025
Completion date
01.09.2027
Registry ID
NCT07083960
Source
anzctr
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