NCT07083960PHASE1Recruiting
OM336 in Autoimmune Cytopenias
Lakefront Biotherapeutics West LLC
Start Date
8/1/2025
Completion Date
9/1/2027
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.
Eligibility Criteria
Age Range: 18 years to 75 years
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
Interventions
DRUG
OM336
Conditions
AIHA - Warm Autoimmune Hemolytic AnemiaAIHA - Cold Autoimmune Hemolytic AnemiaITP - Immune Thrombocytopenia
Locations
City of Hope
Duarte, California 91010
United States
Medstar
Washington D.C., District of Columbia 20007
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
The Canberra Hospital
Canberra, Australian Capital Territory 2605
Australia
Liverpool Hospital
Sydney, New South Wales 2107
Australia
Icon Cancer Center South Brisbane
Brisbane, Queensland 4066
Australia