ClinicalTrials.gov record NCT07083960

OM336 in Autoimmune Cytopenias

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old to 75 years old
SexAll
LocationAustralia, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label Phase 1b study gives repeated subcutaneous doses of OM336 to adults with active autoimmune cytopenias who have relapsed or are refractory to prior treatment. The study primarily looks at safety, tolerability, and how the drug behaves in the body.

What it is studying. The study is testing the safety and tolerability of OM336 when given as subcutaneous injections in ascending dose cohorts. It also measures how the body absorbs and clears OM336 (pharmacokinetics) and whether participants develop anti-drug antibodies, while recording treatment-emergent adverse events over the planned follow-up.

What the researchers hope to learn. To evaluate the safety and tolerability of OM336, to characterize its pharmacokinetics, and to detect anti-drug antibodies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • OM336

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive subcutaneous injections of OM336 in ascending dose groups. They will have regular safety monitoring and will give blood samples for drug level (pharmacokinetic) testing and for detection of anti-drug antibodies. Follow-up visits and safety assessments extend through the early 12-week period and include some measures reported up to 52 weeks; participants must follow study procedures throughout.

How the study is structured. Open-label Phase 1b, multiple ascending-dose (sequential dose escalation) study. Participants receive OM336 by subcutaneous injection in experimental dose cohorts. There is no blinding or placebo group.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Australia, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune hemolytic anemia

This trial is also listed on this site under cold agglutinin disease.

Clinical trials49 trials listed for autoimmune hemolytic anemiaEvery trial the registry lists for autoimmune hemolytic anemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune hemolytic anemia researchLatest monthly update: September 2026. Includes: Negative DAT cases. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 1, 2025
Primary completion
December 2026 (estimated)
Study completion
September 2027 (estimated)
Target enrollment
32 participants (estimated)
Last updated on registry
Sep 3, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Lakefront Biotherapeutics West LLC

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (7)

Terms used on this page · explanations by MedicalUpdates.ai

pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
Relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
prior treatment
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Key Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
ascending dose
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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