OM336 in Autoimmune Cytopenias
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Study details:
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT07083960
Intervention or treatment
DRUG: OM336
Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia
- AIHA - Cold Autoimmune Hemolytic Anemia
- ITP - Immune Thrombocytopenia
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
The Canberra Hospital
Select from list below to view details:
The Canberra Hospital
Canberra, Australian Capital Territory, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Icon Cancer Center South Brisbane
Brisbane, Queensland, Australia
Loading map...
Who is running the clinical trial?
Ouro Medicines
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: OM336 Dose Escalation
| Drug: OM336 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence and severity of treatment emergent adverse events (TEAEs) | 12 weeks |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence and severity of treatment-emergent adverse events (TEAEs) | 52 weeks |
| To assess the pharmacokinetics (PK) of OM336 | Serum concentrations of OM336 | 12 weeks |
| Detection of anti-drug antibodies | Detection of anti-drug antibodies | 12 weeks |
References
Clinical Trials Gov: OM336 in Autoimmune CytopeniasOther trials to consider
Loading suggested trials...
