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

ClinicalTrials.gov ID

NCT07809906

Lead Sponsor

Orum Therapeutics USA, Inc.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

42Estimated

Last Update Posted

Sep 9, 2026Actual

Start Date

Dec 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

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

Brief 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.

• CD123+ Acute Myeloid Leukemia

• ORM-1153

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Orum Therapeutics USA, Inc.INDUSTRY

amaiti@mdanderson.org877-632-6789

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