Actively Recruiting
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias
Led by Ouro Medicines · Updated on 2025-09-30
32
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is an early-phase, open-label, multicenter study evaluating the safety, tolerability, and pharmacokinetics of OM336, a subcutaneously administered drug, in adult participants with active autoimmune cytopenias such as warm and cold autoimmune hemolytic anemia and immune thrombocytopenia. The study focuses on participants who have relapsed or are refractory after at least one prior treatment, aiming to better understand how OM336 behaves and its safety profile in this population. Participants will receive OM336 through subcutaneous injections in ascending dose cohorts to assess safety and immune response over time. The study includes a dose escalation period where dosing increases to evaluate tolerability and pharmacokinetics. OM336 is an engineered bispecific antibody targeting BCMA and CD3, designed to be given under medical supervision in this structured dosing regimen. During the 12-week primary study period, participants will be closely monitored for safety, tolerability, and pharmacokinetics, including detection of anti-drug antibodies. Secondary safety and tolerability assessments continue up to 52 weeks. Participants will undergo regular evaluations and tests to track these outcomes, requiring compliance with study procedures. The total participation duration may extend up to one year with scheduled visits and assessments throughout the study period.
CONDITIONS
Brief Title
OM336 in Autoimmune Cytopenias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active autoimmune cytopenia
- Relapsed or refractory after at least 1 prior treatment
- Body weight at least 55 kg
- Willing to comply with study requirements and procedures
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive the study drug OM336 via subcutaneous injection in ascending dose cohorts to evaluate safety, tolerability, and pharmacokinetics.
Visits occur according to dosing schedule during the 12-week treatment period
Duration - Up to 40 additional weeks (to total 52 weeks)
Participants are monitored for safety and tolerability, including detection of anti-drug antibodies, for an extended period after treatment.
Periodic follow-up visits during the 52-week safety monitoring period
Trial Site Locations
Total: 3 locations
1
The Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
Actively Recruiting
2
Liverpool Hospital
Sydney, New South Wales, Australia, 2107
Actively Recruiting
3
Icon Cancer Center South Brisbane
Brisbane, Queensland, Australia, 4066
Actively Recruiting
Research Team
S
Study Sponsor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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