OM336 in Autoimmune Cytopenias
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias
1 other identifier
interventional
32
1 country
3
Brief Summary
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2025
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2025
CompletedFirst Posted
Study publicly available on registry
July 24, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
September 30, 2025
September 1, 2025
1.3 years
July 9, 2025
September 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability
Incidence and severity of treatment emergent adverse events (TEAEs)
12 weeks
Secondary Outcomes (3)
Safety and Tolerability
52 weeks
To assess the pharmacokinetics (PK) of OM336
12 weeks
Detection of anti-drug antibodies
12 weeks
Study Arms (1)
OM336 Dose Escalation
EXPERIMENTALParticipants will receive OM336 via subcutaneous injection in ascending dose cohorts
Interventions
OM336 is an engineered bispecific antibody directed against BCMA and CD3
Eligibility Criteria
You may qualify if:
- Active autoimmune cytopenia
- Relapsed/refractory after ≥1 prior treatment
- Body weight ≥ 55 kg
- Willing to comply with and study requirements and procedures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ouro Medicineslead
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2025
First Posted
July 24, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share