Clinical trial · Interventional
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
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD123+ Acute Myeloid Leukemia | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ORM-1153 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Part 1 Dose Escalation
- description
- All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation.
- interventionNames
- Drug: ORM-1153
Primary outcomes (3)
- measure
- Optimal Biological Dose(s) of ORM-1153
- timeFrame
- Approximately 24 months
- description
- Identify the Dose-limiting Toxicities for each dose level tested and determine the OBD(s) of ORM-1153
- measure
- Incidence of Dose Limiting Toxicities (DLTs)
- timeFrame
- Approximately 24 months
- description
- Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available