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

Orum Therapeutics

Status and phase

Begins enrollment in 2 months

Phase 1

Conditions

CD123+ Acute Myeloid Leukemia

Treatments

Drug: ORM-1153

Study type

Interventional

Funder types

Industry

Identifiers

NCT07809906

ORM-1153-01-001

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.