Waikato Hospital
Hamilton, Waikato Region, 3204, New Zealand
Location status: Recruiting
Recruiting
NCT Number: NCT07229144
OM336 in Seropositive Autoimmune Diseases
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. OM336 is administered subcutaneously in ascending dose cohorts.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
An open-label, multicenter, multiple ascending dose study evaluating safety, tolerability, and PK/ADA profile of OM336 in seropositive autoimmune diseases. Exploratory assessments include clinical response and biomarkers.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
- Diagnosis of active seropositive autoimmune disease
- Relapsed/refractory after ≥2 prior/ongoing treatments
- Body weight ≥ 50 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 within 3 months of screening or planned during the study
- Pregnant or breastfeeding
Treatment and study plan
OM336
DrugOM336 is an engineered bispecific antibody directed against BCMA and CD3
Primary outcomes
-
Safety and Tolerability
Time frame: 12 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs)
Secondary outcomes
-
Safety and Tolerability
Time frame: 52 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs)
-
To assess the pharmacokinetics (PK) of OM336
Time frame: 12 weeks
Serum concentrations of OM336
-
Detection of anti-drug antibodies
Time frame: 12 weeks
Detection of anti-drug antibodies
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Lakefront Biotherapeutics West LLC
Industry
Registry information
Official study title
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Nov 14, 2025
- Registry last updated
- Jun 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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