Engineered immune cells take on childhood leukemia and lymphoma in landmark trial

NCT ID NCT02625480

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a treatment called KTE-X19, a type of CAR T-cell therapy, in 95 children and adolescents whose B-cell acute lymphoblastic leukemia (ALL) or B-cell non-Hodgkin lymphoma (NHL) had returned or stopped responding to standard treatments. The therapy involves collecting a patient's own immune cells, reprogramming them to attack cancer, and infusing them back after a short course of chemotherapy. The goal was to see if the treatment is safe and can shrink or eliminate the cancer.

What this could mean

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

Active substance
Brexucabtagene autoleucel (KTE-X19), a CAR T-cell therapy made from the patient's own immune cells, given with chemotherapy drugs fludarabine and cyclophosphamide
What this could lead to
If successful, this could offer a powerful treatment option for children and teens with hard-to-treat leukemia or lymphoma that has come back or not responded to standard therapy.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so results may not apply to everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and nervous system problems.

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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

  • Ann & Robert H. Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Bambino Gesù Children's Hospital

    Rome, 00165, Italy

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP

    New York, New York, 10032, United States

  • Hopital Robert Debre - Sevice d'Hemato-immunologic

    Paris, 75935, France

  • Hopital d'Enfants la Timone

    Marseille, 13385, France

  • Hospital Sant Joan de Déu

    Barcelona, 08950, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Institut d'Hematologie et Oncologie Pediatrique

    Lyon, 69373, France

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Jurasz University Hospital 1; Collegium Medicum

    Bydgoszcz, 85-094, Poland

  • Kapi'olani Medical Center for Women and Children

    Honolulu, Hawaii, 96826, United States

  • Karolinska University Hospital

    Stockholm, SE-141 86, Sweden

  • Monroe-Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232, United States

  • Prinses Maxima Centrum

    Utrecht, 3508, Netherlands

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • The Hospital for Sick Children

    Toronto, M5G 1X8, Canada

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCSF Benioff Children's Hospital

    San Francisco, California, 94158, United States

  • Unité d'Oncologie et Hématologie Pédiatriques

    Bordeaux, 33 000, France

  • University Hospital Brno

    Brno, 625 00, Czechia

  • University Hospital Gent

    Ghent, 9000, Belgium

  • University Medical Center Hamburg-Eppendorf (UKE)

    Hamburg, 20246, Germany

  • University of Miami Hospital & Clinics

    Miami, Florida, 33136, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Virginia Health System, Pediatric Hematology/Oncology Clinic

    Charlottesville, Virginia, 22908, United States

  • Wroclaw Medical University

    Wroclaw, 50-556, Poland

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