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Recruiting
NCT07083960
OM336 in Autoimmune Cytopenias
Conditions: AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 32
Sponsor: Lakefront Biotherapeutics West LLC
Location: The Canberra Hospital Canberra Australian Capital Territory
Summary
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Eligibility 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
Source: ClinicalTrials.gov (NCT07083960). StuddyBuddy aggregates publicly available trial information.
