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
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.