OM336 in Autoimmune Cytopenias

NCT07083960 · tracked via the Priya Life Science USA 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

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)

Facility	City	Region	Status
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

Other trials for the same condition

Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease 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 the USA