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New drug aims at CD123 to fight Hard-to-Treat blood cancers

NCT ID NCT07809906

Disease control Sponsor: Orum Therapeutics USA, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing an experimental drug called ORM-1153 in adults whose acute myeloid leukemia (AML) or other blood cancer has returned or stopped responding to treatment. The drug targets CD123, a protein found on the surface of these cancer cells. Participants receive ORM-1153 as an intravenous infusion, and the trial's main goal is to find a safe and tolerable dose. This is a first-in-human Phase 1 study, so it focuses on safety and dosing rather than proving the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental targeted drug called ORM-1153, given as an intravenous infusion
What this could lead to
If ORM-1153 works, it could offer a new option for people whose AML has come back or stopped responding to treatment, and it could help validate CD123 as a target for other blood cancers.
What could go wrong
This is a first-in-human Phase 1 trial with about 42 participants, so its main goal is to find a safe dose, not to prove the drug works. Many experimental cancer drugs fail at this stage, and the infusion may cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CD123+ acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • START - Midwest

    Grand Rapids, Michigan, 49546, United States

    Contact Email: •••••@•••••

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