Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07083960

OM336 in Autoimmune Cytopenias

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

AIHA - Warm Autoimmune Hemolytic Anemia AIHA - Cold Autoimmune Hemolytic Anemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders ITP - Immune Thrombocytopenia Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Canberra Hospital, Canberra, Australian Capital Territory, Australia

Loading trial locations.

About this study

An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OM336

Drug

OM336 is an engineered bispecific antibody directed against BCMA and CD3

Primary outcomes

  1. Safety and Tolerability

    Time frame: 12 weeks

    Incidence and severity of treatment emergent adverse events (TEAEs)

Secondary outcomes

  1. Safety and Tolerability

    Time frame: 52 weeks

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

  2. To assess the pharmacokinetics (PK) of OM336

    Time frame: 12 weeks

    Serum concentrations of OM336

  3. 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.

Study Sponsor

CONTACT

[email protected]

415-429-4887

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 Autoimmune Cytopenias

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 24, 2025
Registry last updated
Jul 14, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.