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RecruitingLast updated: 23 July 2026

Testing a new medicine called OM336 for people with relapsed or refractory autoimmune blood disorders, including immune thrombocytopenia (ITP) and autoimmune haemolytic anaemia (AIHA)An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 75

Clinical summary

Summary

This study is testing a new experimental medicine called OM336 for people with certain autoimmune blood disorders, including immune thrombocytopenia (ITP) and autoimmune haemolytic anaemia (AIHA). 

What is the aim of the study?
The main aims are to determine:

  • Whether OM336 is safe
  • What side effects may occur
  • How the body processes the medicine
  • The most appropriate dose to study in future research

Who may be able to take part?
You may be eligible to join this study if:

  • You are aged between 18 and 75 years
  • You have immune thrombocytopenia (ITP) or autoimmune haemolytic anaemia (AIHA)
  • Your condition has come back, worsened, or has not responded well to previous treatment
  • You have received at least one prior treatment for your condition

What does participation involve?
If you choose to take part, you will receive OM336 as an injection under the skin. Researchers will closely monitor your health and any side effects. They will also perform tests to understand how the medicine moves through and affects your body.

 

Conditions

This trial is treating people with active autoimmune cytopenia, including immune thrombocytopenia

Eligibility

Inclusion

  • Active autoimmune cytopenia
  • Relapsed/refractory after ≥1 prior treatment
  • Body weight ≥ 55 kg
  • Willing to comply with and study requirements and procedures

Exclusion

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Lakefront Biotherapeutics West LLC

Scientific Title

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias

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