New immunotherapy flotetuzumab tested in kids with Tough-to-Treat leukemia

NCT ID NCT04158739

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a drug called flotetuzumab in children and young adults with acute myeloid leukemia (AML) that has returned or not responded to standard treatment. Flotetuzumab is an immunotherapy designed to help the body's immune cells find and attack cancer cells. The main goals are to find the safest dose and understand side effects, not yet to prove it works as a treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
flotetuzumab (an immunotherapy drug that helps immune cells attack cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for children with hard-to-treat AML.
What could go wrong
This is a very early (Phase 1) trial with only 16 participants, so it is mainly checking safety and dosing. The drug may not work well or could cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030, United States

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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