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Clinical Trials in the USA / NCT07809906
Recruiting Phase 1

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

NCT07809906 · tracked via the Priya Life Science USA tracker
Sponsor
Orum Therapeutics USA, Inc
Phase
Phase 1
Started
2026-09-23
Last updated
2026-11-02

Condition(s) studied

CD123+ Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

ORM-1153

ORM-1153: Intravenous Infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Optimal Biological Dose(s) of ORM-1153 — Approximately 24 months
    Identify the Dose-limiting Toxicities for each dose level tested and determine the OBD(s) of ORM-1153
  • Incidence of Dose Limiting Toxicities (DLTs) — Approximately 24 months
    Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs
  • Incidence of Treatment Emergent Adverse Events (TEAEs) — Approximately 24 months
    Evaluate the safety and tolerability of ORM-1153 by identifying TEAEs

Trial sites (2)

FacilityCityRegionStatus
START - Midwest Grand Rapids Michigan Recruiting
MD Anderson Cancer Center Houston Texas Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07809906 on ClinicalTrials.gov ↗ ← All trials in the USA