Phase 1 Open Label, PK, Safety study of CLN-049 (Acute Myeloid Leukemia/Myelodysplastic Syndrome)

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:
  • Are diagnosed with AML or MDS
  • Did not respond to standard therapies or had their disease come back after treatment
  • Have not received any radiation therapy within 28 days of starting the study drug
  • Have not been treated with immunotherapy with checkpoint inhibitors within 6 weeks of starting the study drug
  • Have never been treated with chimeric antigen receptor (CAR-T) cell therapy or other types of modified T cell therapy
For more information about who can join this study, please contact the study team at terri.lucas@duke.edu 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?

Description

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:
  • Have a physical exam
  • Have an ECG
  • Have blood and urine samples
  • Have a bone marrow biopsy
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

Open to Enrollment
ClinicalTrials.gov