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

What is the 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).

What is the Condition Being Studied?

Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Who Can Participate in the Study?

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.

Grupo etario
Adultos

What is Involved?

Si decide unirse a este estudio, pasará por un período de detección para determinar si es elegible. Durante este período de detección, usted:

  • Hacer un examen físico
  • 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.

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
Especialista en terapia celular
Protocol Number
IRB: PRO00115147
NCT: NCT05143996
Phase
Fase I
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción