OM336 in Autoimmune Cytopenias
Purpose
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia
- AIHA - Cold Autoimmune Hemolytic Anemia
- ITP - Immune Thrombocytopenia
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Active autoimmune cytopenia - Relapsed/refractory after ≥1 prior treatment - Body weight ≥ 55 kg - Willing to comply with and study requirements and procedures
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental OM336 Dose Escalation |
Participants will receive OM336 via subcutaneous injection in ascending dose cohorts |
|
Recruiting Locations
Medstar
Washington D.C., District of Columbia 20007
Washington D.C., District of Columbia 20007
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Fred Hutchinson Cancer Center
Seattle, Washington 98109
Seattle, Washington 98109
More Details
- Status
- Recruiting
- Sponsor
- Lakefront Biotherapeutics West LLC
Detailed Description
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.