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

NCT ID NCT02625480

First seen Nov 01, 2025 · Last updated Jun 19, 2026 · Updated 30 times

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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.

Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia B-cell neoplasm B-cell non-Hodgkin lymphoma precursor B-cell acute lymphoblastic leukemia Recurrence

As listed by the trial registrant

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