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NOT YET RECRUITING
NCT07809906
PHASE1

Study of ORM-1153 in Acute Myeloid Leukemia (AML) With CD123 Expression

Sponsor: Orum Therapeutics USA, Inc.

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-12

Completion Date

2029-12

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

ORM-1153

Intravenous Infusion

Locations (2)

START - Midwest

Grand Rapids, Michigan, United States

MD Anderson Cancer Center

Houston, Texas, United States