Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called CLN-049 (the study drug) for people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with AML or MDS</li>
<li>Did not respond to standard therapies or had their disease come back after treatment</li>
<li>Have not received any radiation therapy within 28 days of starting the study drug</li>
<li>Have not been treated with immunotherapy with checkpoint inhibitors within 6 weeks of starting the study drug</li>
<li>Have never been treated with chimeric antigen receptor (CAR-T) cell therapy or other types of modified T cell therapy</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: terri.lucas@duke.edu">terri.lucas@duke.edu</a> or 919-681-6580.
<li>Are diagnosed with AML or MDS</li>
<li>Did not respond to standard therapies or had their disease come back after treatment</li>
<li>Have not received any radiation therapy within 28 days of starting the study drug</li>
<li>Have not been treated with immunotherapy with checkpoint inhibitors within 6 weeks of starting the study drug</li>
<li>Have never been treated with chimeric antigen receptor (CAR-T) cell therapy or other types of modified T cell therapy</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: terri.lucas@duke.edu">terri.lucas@duke.edu</a> or 919-681-6580.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:<ul>
<li>Have a physical exam</li>
<li>Have an ECG</li>
<li>Have blood and urine samples</li>
<li>Have a bone marrow biopsy</li></ul>
If you are eligible to join, you will proceed to the study drug portion of the study. Depending on when you join the study, you will be assigned to Part A, Part B, or Part C.
If you join the study and participate in Part A or Part B, you will get a dose of the study drug through an intravenous (IV) infusion that takes about 1 hour. Participants in Part A will get only 1 dose of the study drug. Participants in Part B will get a dose of the study drug every 7 days.
If you join the study and participate in Part C, you will get a dose of the study drug as a subcutaneous injection (shot under the skin) that takes about 1 minute. Participants in Part C will get a dose of the study drug every 7 days.
If you are in Part B or Part C of the study, you will take the study drug for up to 2 years, unless you or the study doctor decide that you are not getting a benefit and should stop.
<li>Have a physical exam</li>
<li>Have an ECG</li>
<li>Have blood and urine samples</li>
<li>Have a bone marrow biopsy</li></ul>
If you are eligible to join, you will proceed to the study drug portion of the study. Depending on when you join the study, you will be assigned to Part A, Part B, or Part C.
If you join the study and participate in Part A or Part B, you will get a dose of the study drug through an intravenous (IV) infusion that takes about 1 hour. Participants in Part A will get only 1 dose of the study drug. Participants in Part B will get a dose of the study drug every 7 days.
If you join the study and participate in Part C, you will get a dose of the study drug as a subcutaneous injection (shot under the skin) that takes about 1 minute. Participants in Part C will get a dose of the study drug every 7 days.
If you are in Part B or Part C of the study, you will take the study drug for up to 2 years, unless you or the study doctor decide that you are not getting a benefit and should stop.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1, Open-label, Preliminary Pharmacokinetics (PK) and Safety Study of CLN-049 (An fms-like tyrosine kinase 3 [FLT3] x cluster of differentiation 3 [CD3] bispecific T cell engager) in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Principal Investigator
Sanghee
Hong
Protocol Number
PRO00115147
NCT ID
NCT05143996
Phase
I
Enrollment Status
Pending Open to Enrollment