Clinical Trials | Phase 1 First-In-Human Multi-Region Clinical Trial of ORM-1153 in Participants with Relapsed or Refractory Acute Myeloid Leukemia or Other Hematological Malignancies with CD123 Expression

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Relapsed or Refractory Acute Myeloid Leukemia or Other Hematological Malignancies with CD123 Expression that have had some prior therapy for their condition. The purpose of this study is to investigate whether a new experimental treatment, called ORM 1153, will be a safe and possibly effective treatment option for participants with diseases of the bone marrow, including acute myeloid leukemia (AML) that have relapsed (reappeared after a period of remission) or are refractory (not responding to current treatment), and which have a particular protein (called CD123) on the cancer cells’ surface. ORM 1153 has not been tested in humans before. The study is designed to find a safe and effective dose of ORM 1153. In this study, you will receive ORM-1153 as an intravenous infusion once every 3 weeks on Day 1 of each 21 day cycle. The first infusion of ORM-1153 will be administered over 90 minutes. If you tolerate that initial infusion well, all other infusions may be shortened to approximately 30 minutes. You will need to remain in the hospital for up to 4 hours after the end of your first infusion (Cycle 1 Day 1) and 1 hour after the end of your second infusion for observation and blood sampling. For the following cycles, you will need to remain in the hospital for approximately 30 minutes after your infusions. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. You will have an end-of-treatment visit as soon as is feasible after your last dose of ORM 1153, which includes further assessments. You will also have a safety follow-up visit about 30 days after the last dose of ORM 1153. We would like to keep track of your medical condition for the rest of your life. We will contact you by telephone every 3 months to check on your well-being and any new anti-tumor treatments that you started after you finished this study treatment. Additional information found here: Study Details | NCT07809906 | Study of ORM-1153 in Acute Myeloid Leukemia (AML) With CD123 Expression | ClinicalTrials.gov For questions, contact: [email protected]