AIHA - Warm Autoimmune Hemolytic AnemiaPhase 1NCT07083960
OM336 in Autoimmune Cytopenias
A Phase 1 study testing OM336 in people with AIHA - Warm Autoimmune Hemolytic Anemia and AIHA - Cold Autoimmune Hemolytic Anemia, run by Lakefront Biotherapeutics West LLC at 7 sites in 2 countries.
Trial summary
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
- What is being tested?
- OM336
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Aug 2025to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active autoimmune cytopenia
- Relapsed/refractory after ≥1 prior treatment
- Body weight ≥ 55 kg
- Willing to comply with and study requirements and procedures
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Primary Contact, 734-764-1817, jreginal@med.umich.edu
- Recruiting
City of Hope
Duarte, California, 91010
Primary Contact, (888) 734-0917, shhussain@coh.org
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Primary Contact, 855-557-0555, Milleris@fredhutch.org
- Recruiting
Medstar
Washington D.C., District of Columbia, 20007
Primary Contact, 202-444-2000, jacobsh@georgetown.edu
Australia3 sites, 3 recruiting
- Recruiting
Icon Cancer Center South Brisbane
Brisbane, Queensland, 4066
Clinical Research Coordinator, +61 7 3737 4795, Annabelle.morton@icon.team
- Recruiting
The Canberra Hospital
Canberra, Australian Capital Territory, 2605
Clinical Research Coordinator, +61 2 5124 4338, Ryshelle.kilby@act.gov.au
- Recruiting
Liverpool Hospital
Sydney, New South Wales, 2107
Clinical Research Coordinator, +61 474 279 274, pinky.patel@health.nsw.gov.au
About this study
Official title: An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Read the detailed description
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
- Being tested
- OM336
- Medical subject headings
- Anemia, Hemolytic, Autoimmune, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM336Drug
OM336 is an engineered bispecific antibody directed against BCMA and CD3
| Study group | Role | What they receive |
|---|---|---|
| OM336 Dose Escalation | Experimental | Participants will receive OM336 via subcutaneous injection in ascending dose cohorts Receives: Drug: OM336 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence and severity of treatment emergent adverse events (TEAEs)
Measured: 12 weeks
Secondary outcomes (3)
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: 52 weeks
To assess the pharmacokinetics (PK) of OM336
Serum concentrations of OM336
Measured: 12 weeks
Detection of anti-drug antibodies
Detection of anti-drug antibodies
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIHA - Warm Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics West LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083960
- Sponsor's protocol ID
- OM336-AIC-1001
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias
- ClinicalTrials.gov ID
- NCT07083960
- Acronym / sponsor ID
- OM336-AIC-1001
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Lakefront Biotherapeutics West LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Detailed description
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OM336 Dose Escalation | Experimental | Drug: OM336Participants will receive OM336 via subcutaneous injection in ascending dose cohorts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OM336OM336 is an engineered bispecific antibody directed against BCMA and CD3 | Drug | OM336 Dose Escalation |
Primary outcome
Safety and Tolerability
Time frame: 12 weeks
Incidence and severity of treatment emergent adverse events (TEAEs)
3 secondary outcomes
Safety and Tolerability
Time frame: 52 weeks
To assess the pharmacokinetics (PK) of OM336
Time frame: 12 weeks
Detection of anti-drug antibodies
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OM336 in people with AIHA - Warm Autoimmune Hemolytic Anemia and AIHA - Cold Autoimmune Hemolytic Anemia, run by Lakefront Biotherapeutics West LLC at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Sponsor (415-429-4887, clinicaltrials@lakefrontbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.