ORM-1153 for CD123+ AML: a first-in-human dose study
Official title: Phase 1 First-in-Human Multi-Region Clinical Trial of ORM-1153 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Other Hematological Malignancies With CD123 Expression
Run by Orum Therapeutics USA, Inc. · NCT07809906 · Data updated 2026-11-12
ThisPhase 1 trial tests whether ORM-1153 is safe and may help some adults with CD123-positive AML.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Orum Therapeutics USA, Inc. Industry-sponsored |
| Locations | 2 sites (Grand Rapids, Michigan and 1 other locations) |
| Status | Recruiting |
| Started | September 23, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT07809906 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with relapsed or refractory CD123+ AML and adequate organ function, ECOG ≤2, not recently treated with systemic anticancer therapy or recent stem cell transplant per protocol.
✕Probably not a fit
Patients who do not respond to ORM-1153 or who have exclusion criteria may not benefit from this treatment.
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 early human study to determine the safe starting dose and how the body handles ORM-1153 in adults with relapsed or refractory AML expressing CD123. Participants receive ORM-1153 as an IV infusion on a defined schedule and attend clinic visits early in treatment to monitor safety and dosing. The study will exclude certain conditions and recent treatments to restrict factors that could affect safety and interpretation of results. The trial is conducted at sites in Grand Rapids, MI and Houston, TX under Orum Therapeutics USA, Inc.
Why it matters
Potential benefit: If successful, participants might experience disease control or stabilization and contribute to development of a new targeted therapy for CD123+ AML.
How similar studies have gone: Previous early-phase studies of targeted therapies in AML show potential signals of safety and activity, but this approach with ORM-1153 is still in early development.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥18 years of age (or ≥19 years of age according to local regulatory guidelines) at the time of signature of the informed consent form. * Documented diagnosis of relapsed or refractory AML with any detectable level of CD123 as evaluated by local assessment. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Adequate organ and coagulation function. Exclusion Criteria: * Diagnosed with Acute Promyelocytic Leukemia. * Systemic antineoplastic agent therapy given within 14 days or 5 half-lives prior to the first dose of ORM-1153 (whichever is shorter). * Hematopoietic Stem Cell Transplantation within 3 months of the first dose of ORM-1153. * Total White Blood Cell count \>25,000/µL.
Where it's running
-
START - Midwest
Grand Rapids, Michigan, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: Orum Therapeutics USA, Inc.
- Email: ClinicalTrials@orumrx.com
- Phone: 617-714-9597
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Immunotherapy using modified NK cells for treating relapsed or refractory AML
This study is testing a new treatment using modified immune cells to see if it can help people with relapsed or hard-to-treat Acute Myeloid Leukemia feel better and achieve remission.
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.