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

Conditions

• CD123+ Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ORM-1153 — DRUG
  Intravenous Infusion

Study Details

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.

Key Dates

First listed

Sep 9, 2026

Start date

Dec 31, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2029

Study Design

Enrollment

42 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Dose Escalation
  All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation.

Primary Outcome Measure

Optimal Biological Dose(s) of ORM-1153 [ Time Frame: Approximately 24 months ]

Central Contacts

• Orum Therapeutics USA, Inc.
  617-714-9597
  [email protected]

Locations (2)

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