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Clinical Trials in Australia / NCT07083960
Recruiting Phase 1

OM336 in Autoimmune Cytopenias

NCT07083960 · tracked via the Priya Life Science Australia tracker
Sponsor
Lakefront Biotherapeutics West LLC
Phase
Phase 1
Started
2025-08-01
Last updated
2026-09-03

Condition(s) studied

AIHA - Warm Autoimmune Hemolytic AnemiaAIHA - Cold Autoimmune Hemolytic AnemiaITP - Immune Thrombocytopenia

Investigational drug(s) / intervention(s)

OM336

OM336: OM336 is an engineered bispecific antibody directed against BCMA and CD3

Study summary

An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria: * Active autoimmune cytopenia * Relapsed/refractory after ≥1 prior treatment * Body weight ≥ 55 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 or splenectomy within 3 months of screening or planned during the study * Pregnant or breastfeeding

Primary outcome measure(s)

  • Safety and Tolerability — 12 weeks
    Incidence and severity of treatment emergent adverse events (TEAEs)

Trial sites (7)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
Medstar Washington D.C. District of Columbia Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
The Canberra Hospital Canberra Australian Capital Territory Recruiting
Liverpool Hospital Sydney New South Wales Recruiting
Icon Cancer Center South Brisbane Brisbane Queensland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07083960 on ClinicalTrials.gov ↗ ← All trials in Australia