OM336 for autoimmune hemolytic anemia and immune thrombocytopenia
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias
This phase 1 trial will test whether subcutaneously given OM336 is safe and tolerable in adults with relapsed or refractory autoimmune hemolytic anemia or immune thrombocytopenia.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ouro Medicines Industry-sponsored |
| Locations | 3 sites (Canberra, Australian Capital Territory and 2 other locations) |
| Trial ID | NCT07083960 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multicenter, ascending-dose phase 1 study of subcutaneous OM336 in adults with active autoimmune cytopenias who have relapsed or are refractory to prior treatment. The trial will escalate doses to characterize safety, tolerability, pharmacokinetics (PK), and anti-drug antibody (ADA) responses. Participants will be closely monitored for adverse events, laboratory changes, and drug levels over a predefined follow-up period. Key exclusions include prior BCMA-targeted therapy, recent serious infection, recent major surgery or splenectomy, and pregnancy or breastfeeding.
Who should consider this trial
Good fit: Adults with active warm or cold autoimmune hemolytic anemia or immune thrombocytopenia who are relapsed/refractory after at least one prior therapy, weigh at least 55 kg, and can comply with study visits and procedures are the intended participants.
Not a fit: Patients who are pregnant or breastfeeding, have had a recent clinically significant infection or major surgery/splenectomy, or who previously received BCMA-targeted therapy are unlikely to qualify and may not benefit from participation.
Why it matters
Potential benefit: If successful, OM336 could offer a new treatment option that reduces immune-driven destruction of blood cells for patients who have not responded to existing therapies.
How similar studies have performed: This is an early-phase effort for OM336 in autoimmune cytopenias and there are limited prior clinical data showing success with this exact agent in these conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Canberra, Australian Capital Territory and 2 other locations
- The Canberra Hospital — Canberra, Australian Capital Territory, Australia (Recruiting)
- Liverpool Hospital — Sydney, New South Wales, Australia (Recruiting)
- Icon Cancer Center South Brisbane — Brisbane, Queensland, Australia (Recruiting)
Study contacts
- Study coordinator: Study Sponsor
- Email: info@ouromeds.com
- Phone: 415-429-4887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.