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CRISPR gene therapy aims to free kids from lifelong blood transfusions

NCT ID NCT05356195

First seen Oct 31, 2025 · Last updated Jun 19, 2026 · Updated 32 times

Summary

This phase 3 trial tests a single dose of CTX001, a CRISPR gene therapy made from the child's own blood stem cells, for children with transfusion-dependent beta-thalassemia. The goal is to help them become transfusion-free for at least 12 months. Sixteen children will receive the treatment after chemotherapy to prepare their bone marrow.

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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

  • Great Ormond Street Hospital for Children

    London, United Kingdom

  • Hospital for Sick Children - Hematology

    Toronto, Canada

  • IRCSS Ospedale Pediatrico Bambino Gesu - Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica

    Rome, Italy

  • St.Mary's Hospital - Children's Clinical Research Facility

    London, United Kingdom

  • TriStar Medical Group Children's Specialists - Pediatric Oncology

    Nashville, Tennessee, 37203, United States

  • University Hospital Dusseldorf - Department of Pediatric Oncology, Hematology and Clinical Immunology

    Düsseldorf, Germany

What this could mean

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

Active substance

CTX001 (Exagamglogene autotemcel) - a CRISPR gene therapy made from the patient's own blood stem cells

What this could lead to

If it works, this could allow children with severe beta-thalassemia to stop needing regular blood transfusions for at least a year or more.

What could go wrong

This is an early-phase study with only 16 participants, so results may not apply to everyone. The treatment requires strong chemotherapy beforehand, which carries serious risks like infection and infertility.

Conditions

The condition(s) this trial relates to.

beta thalassemia beta-thalassemia major hematologic disorder hemoglobinopathy hereditary disease inherited hemoglobinopathy thalassemia

As listed by the trial registrant

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