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A drug, CLN-049, to treat acute myeloid leukemia (AML) that has come back (relapsed) or has not gotten better with treatment (refractory), or myelodysplastic disorder (MDS)

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18 and older

Phase 1

11 Locations

NCT05143996

Clinical Trial Goal


To find out:
  • The highest dose of CLN-049 that's safe to give
  • If CLN-049 is safe and works well to treat AML that has relapsed or is refractory or MDS

You may be able to join this trial if you:


  • Are 18 years or older
  • Have one of the following:
    • AML that has relapsed or is refractory
    • MDS
  • Have not been treated with CAR T-cell therapy
  • Have not been treated with a drug that targets FLT3
  • Have not had allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 6 months
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


CLN-049 is a bispecific T-cell engager (BiTE) antibody that targets FLT3 on certain cells. 

You’ll get treatment in cycles that last 1 month. In each cycle, you'll get: 
  • CLN-049 – Given as intravenous (IV) infusions or as a shot under your skin up to 1 time each week

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years.

The Food and Drug Administration (FDA) has not yet approved CLN-049. 

Contacts


Timna Serino, +1 617 410 4650, ClinOps@cullinantx.com

Locations

University of Alabama O'Neal Cancer CenterRECRUITING

Birmingham, Alabama
Anne C Durena, 205-801-9034, accoicoudurena@uabmc.edu

UCLARECRUITING

Los Angeles, California
Bruck Habtemariam, BHabtemariam@mednet.ucla.edu

Moffitt Cancer CenterRECRUITING

Tampa, Florida
Mohamad Abou Khalil, Mohamad.AbouKhalil@moffitt.org

University of Miami Health SystemRECRUITING

Miami, Florida
Jennifer Posada, 305-243-2647, jxp2320@med.miami.edu

Emory University HospitalRECRUITING

Atlanta, Georgia
Lindsey E. Overman, lindsey.e.overman@emory.edu

Massachusetts General HospitalCOMPLETED

Boston, Massachusetts

New York UniversityRECRUITING

New York, New York
Rachel Joseph, Rachel.Joseph@nyulangone.org

Roswell Park Cancer InstituteRECRUITING

Buffalo, New York
Wendy Walinski, 1-800-767-9355, wendy.walinski@roswellpark.org

Duke Cancer CenterRECRUITING

Durham, North Carolina
Samuel Dell, 919-681-5698, samuel.dell@duke.edu

Cincinnati Children's Hospital Medical CenterWITHDRAWN

Cincinnati, Ohio

MD AndersonRECRUITING

Houston, Texas
Allison Pike, APike@mdanderson.org

ClinicalTrials.gov record


NCT05143996. First posted on 12/3/21

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