NCT07809906RecruitingPhase 1
Study of ORM-1153 in Acute Myeloid Leukemia (AML) With CD123 Expression
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
The goal of this Phase 1 clinical trial is to understand whether a new experimental treatment, called ORM-1153, will be a safe and possibly effective treatment option for participants with blood cancers such as Acute Myeloid Leukemia (AML) which have a particular protein (called Cluster of Differentiation 123 or CD123) on the cancer cell's surface. Phase 1 studies are designed to find a safe and effective dose. Participants will be receiving ORM-1153 at the defined study frequency as an infusion into the vein. They will need to visit the clinic frequently during the first few months of treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 27 Aug 2026
- Start date
- 23 Sept 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Orum Therapeutics USA, Inc.
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07809906
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 42
- From 23 Sept 2026 to the primary completion date, Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- Total White Blood Cell count \>25,000/µL.
Other
- Diagnosed with Acute Promyelocytic Leukemia.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.