OM336 for autoimmune hemolytic anemia and immune thrombocytopenia
Official title: An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias
Run by Lakefront Biotherapeutics West LLC · NCT07083960 · Data updated 2026-11-12
This phase 1 trial will test whether subcutaneously given OM336 is safe and tolerable in adults with relapsed or refractory autoimmune hemolytic anemia or immune thrombocytopenia.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Lakefront Biotherapeutics West LLC Industry-sponsored |
| Locations | 7 sites (Duarte, California and 6 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 2026 |
| Study ends | September 2027 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07083960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with active warm or cold autoimmune hemolytic anemia or immune thrombocytopenia who are relapsed/refractory after at least one prior therapy, weigh at least 55 kg, and can comply with study visits and procedures are the intended participants.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have had a recent clinically significant infection or major surgery/splenectomy, or who previously received BCMA-targeted therapy are unlikely to qualify and may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, multicenter, ascending-dose phase 1 study of subcutaneous OM336 in adults with active autoimmune cytopenias who have relapsed or are refractory to prior treatment. The trial will escalate doses to characterize safety, tolerability, pharmacokinetics (PK), and anti-drug antibody (ADA) responses. Participants will be closely monitored for adverse events, laboratory changes, and drug levels over a predefined follow-up period. Key exclusions include prior BCMA-targeted therapy, recent serious infection, recent major surgery or splenectomy, and pregnancy or breastfeeding.
Why it matters
Potential benefit: If successful, OM336 could offer a new treatment option that reduces immune-driven destruction of blood cells for patients who have not responded to existing therapies.
How similar studies have gone: This is an early-phase effort for OM336 in autoimmune cytopenias and there are limited prior clinical data showing success with this exact agent in these conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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City of Hope
Duarte, California, United States Recruiting -
Medstar
Washington D.C., District of Columbia, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting -
The Canberra Hospital
Canberra, Australian Capital Territory, Australia Recruiting -
Liverpool Hospital
Sydney, New South Wales, Australia Recruiting
Show 1 more location
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Icon Cancer Center South Brisbane
Brisbane, Queensland, Australia Recruiting
Study contacts
- Study coordinator: Study Sponsor
- Email: clinicaltrials@lakefrontbio.com
- Phone: 415-429-4887
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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National longitudinal cohort of autoimmune hemolytic anemia in China
This project will follow people with warm, cold, or mixed autoimmune hemolytic anemia treated at a major Tianjin hematology center to see what treatments they receive and how well they do over time.
-
Multi-target drugs sequentially combine therapy in adults with newly diagnosed immune thrombocytopenia
This study tests whether starting with standard steroids plus a TPO-RA, then adding a second targeted therapy if needed, can improve platelet counts in adults with newly diagnosed ITP.
-
CTX112 (zugo-cel) for relapsed/refractory ITP and wAIHA in adults
This trial tests CTX112, an off-the-shelf CD19 CAR-T therapy, to see if it can help adults with relapsed or refractory ITP or wAIHA.
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Universal (allogeneic) CAR T-cell therapy targeting CD19 and BCMA for relapsed/refractory autoimmune hemolytic anemia
This trial will try a single infusion of universal anti‑CD19/BCMA CAR T-cells for people aged 10 and up whose autoimmune hemolytic anemia has not responded to at least three prior treatments.
-
Efgartigimod IV for adolescents (12–17) with chronic immune thrombocytopenia
This trial will try intravenous efgartigimod to see if it safely raises platelet counts in people aged 12 to 17 with chronic ITP.
-
Lower starting dose of avatrombopag for immune thrombocytopenia (ITP)
This pilot will try a lower starting dose of avatrombopag to raise platelet counts in adults with primary ITP who need second-line treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.