About this trial
This trial is looking at a new medicine called CLN-049. It is for adults with relapsed or refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). The main goal is to see how well the medicine works and how safe it is. The trial has three parts where patients will receive the medicine in different ways and be monitored for safety.
This is a Phase 1 trial, which means it is the first time the medicine is being tested in humans. The trial hopes to include about 60 participants. It is regulated by the FDA.
Who can join
Adults aged 18 and older can join. Participants must have a confirmed diagnosis of AML or MDS. They should be willing to follow the study's rules and give consent. Some conditions may prevent joining, such as active central nervous system leukemia or recent treatments that could interfere. The trial team will check if you are eligible.
Conditions
Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants in this trial will receive CLN-049 in three parts. In Part A, they will get a single dose through an IV and will be monitored for 28 days. In Part B, patients will receive the medicine every week for 28 days after an initial dose, followed by up to 2 years of follow-up. Part C involves weekly injections under the skin for 28 days, with long-term follow-up after that. Everyone will receive CLN-049; there are no random assignments.
Where
This trial is running at 11 locations in the United States. 9 of them are currently recruiting.
Duke Cancer Center
Durham, North Carolina
Emory University Hospital
Atlanta, Georgia
MD Anderson
Houston, Texas
Moffitt Cancer Center
Tampa, Florida
New York University
New York, New York
Roswell Park Cancer Institute
Buffalo, New York
UCLA
Los Angeles, California
University of Alabama O'Neal Cancer Center
Birmingham, Alabama
The first 8 of 11 sites are listed here. The registry record has the full list.