A Phase 1 interventional study of ORM-1153 in CD123+ Acute Myeloid Leukemia, sponsored by Orum Therapeutics USA, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Orum Therapeutics USA, Inc. · Phase 1, Interventional, and Treatment
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.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's planned enrollment of 42 is close to the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Orum Therapeutics USA, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation.
Drug: ORM-1153
Intravenous Infusion
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
Time frame: Approximately 24 months
Incidence of Dose Limiting Toxicities (DLTs)
Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs
Time frame: Approximately 24 months
Incidence of Treatment Emergent Adverse Events (TEAEs)
Evaluate the safety and tolerability of ORM-1153 by identifying TEAEs
Time frame: Approximately 24 months
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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Orum Therapeutics USA, Inc.