CD123+ Acute Myeloid LeukemiaPhase 1NCT07809906
Study of ORM-1153 in Acute Myeloid Leukemia (AML) With CD123 Expression
A Phase 1 study testing ORM-1153 in people with CD123+ Acute Myeloid Leukemia, run by Orum Therapeutics USA, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD123+ Acute Myeloid Leukemia
- What is being tested?
- ORM-1153
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
START - Midwest
Grand Rapids, Michigan, 49546
Andrew Sochacki, MD, 616-389-6346, information@startresearch.com
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Abhishek Maiti, MD, 877-632-6789, amaiti@mdanderson.org
About this study
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
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.
- Conditions
- CD123+ Acute Myeloid Leukemia
- Being tested
- ORM-1153
- Keywords
- Antibody Drug Conjugate, Protein-Degradation, GSPT1, CD123, AML, Hematologic Malignancies
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORM-1153Drug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation | Experimental | All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation. Receives: Drug: ORM-1153 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Biological Dose(s) of ORM-1153
Identify the Dose-limiting Toxicities for each dose level tested and determine the OBD(s) of ORM-1153
Measured: Approximately 24 months
Incidence of Dose Limiting Toxicities (DLTs)
Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs
Measured: Approximately 24 months
Incidence of Treatment Emergent Adverse Events (TEAEs)
Evaluate the safety and tolerability of ORM-1153 by identifying TEAEs
Measured: Approximately 24 months
Secondary outcomes (13)
Maximum Observed Serum Concentration (Cmax) of ORM-1153, total antibody and the payload
Measured: Approximately 36 months
Time to Maximum Observed Serum Concentration (Tmax) of ORM-1153, total antibody and the payload
Measured: Approximately 36 months
Area Under the Serum Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of ORM-1153, total antibody and the payload
Measured: Approximately 36 months
Overall Response Rate (ORR) of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
Duration of Response (DoR) of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
Best Overall Response (BOR) of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
CR with Partial (CRh) and Incomplete (CRi) Recovery of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
Event Free Survival (EFS) of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
Relapse Free Survival (RFS) of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
Overall Survival (OS) of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
Transition Rate to Allogeneic Hematopoietic Stem Cell Transplantation of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
GSPT1 Protein Degradation and CD123 Receptor Occupancy of ORM-1153 at various dose levels including OBD(s)
Measured: Approximately 36 months
Study the anti-drug antibodies against ORM-1153
Measured: Approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start23 Sep 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD123+ Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orum Therapeutics USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809906
- Sponsor's protocol ID
- ORM-1153-01-001
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07809906
- Acronym / sponsor ID
- ORM-1153-01-001
- Conditions
- CD123+ Acute Myeloid Leukemia
- Keywords
- Antibody Drug Conjugate, Protein-Degradation, GSPT1, CD123, AML, Hematologic Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Orum Therapeutics USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Drug: ORM-1153All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORM-1153Intravenous Infusion | Drug | Part 1 Dose Escalation |
Primary outcome
Optimal Biological Dose(s) of ORM-1153
Time frame: 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)
Time frame: Approximately 24 months
Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Approximately 24 months
Evaluate the safety and tolerability of ORM-1153 by identifying TEAEs
13 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of ORM-1153, total antibody and the payload
Time frame: Approximately 36 months
Time to Maximum Observed Serum Concentration (Tmax) of ORM-1153, total antibody and the payload
Time frame: Approximately 36 months
Area Under the Serum Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of ORM-1153, total antibody and the payload
Time frame: Approximately 36 months
Overall Response Rate (ORR) of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
Duration of Response (DoR) of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
Best Overall Response (BOR) of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
CR with Partial (CRh) and Incomplete (CRi) Recovery of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
Event Free Survival (EFS) of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
Relapse Free Survival (RFS) of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
Overall Survival (OS) of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
Transition Rate to Allogeneic Hematopoietic Stem Cell Transplantation of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
GSPT1 Protein Degradation and CD123 Receptor Occupancy of ORM-1153 at various dose levels including OBD(s)
Time frame: Approximately 36 months
Study the anti-drug antibodies against ORM-1153
Time frame: Approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORM-1153 in people with CD123+ Acute Myeloid Leukemia, run by Orum Therapeutics USA, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orum Therapeutics USA, Inc. (617-714-9597, ClinicalTrials@orumrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Biological Dose(s) of ORM-1153 (time frame: Approximately 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.