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OM336

Phase 1

AIHA - Warm Autoimmune Hemolytic Anemia | Small molecule | Other |Lakefront Biotherapeutics|Last Updated: Jul 14, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical trial landscape

OM336 · 2 trials · 5 indications

Phase 1 2
NCT07229144OM336 in Seropositive Autoimmune DiseasesSjogrens Disease
RECRUITING39 Analytics
NCT07083960OM336 in Autoimmune CytopeniasAIHA - Warm Autoimmune Hemolytic Anemia
RECRUITING32 Analytics
PHASE1RECRUITING
OM336 in Seropositive Autoimmune Diseases
Sjogrens DiseaseUnlock trial analytics
PHASE1RECRUITING
OM336 in Autoimmune Cytopenias
AIHA - Warm Autoimmune Hemolytic AnemiaUnlock trial analytics
Study Endpoints
Primary Endpoints
Safety and Tolerability
12 weeks

Incidence and severity of treatment-emergent adverse events (TEAEs)

Secondary Endpoints
Safety and Tolerability
52 weeks
To assess the pharmacokinetics (PK) of OM336
12 weeks
Detection of anti-drug antibodies
12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OM336 Dose EscalationEXPERIMENTALParticipants will receive OM336 via subcutaneous injection in ascending dose cohorts
Interventions
NameTypeDescription
OM336DRUGOM336 is an engineered bispecific antibody directed against BCMA and CD3
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 * Cl...

Countries:New ZealandAustralia
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Competitive Landscape -Autoimmune Hemolytic Anemia 9 trials (matched to "AIHA - Warm Autoimmune Hemolytic Anemia")