NCT05356195

A Phase 3 Study to Evaluate the Safety and Efficacy of a Single Dose of CTX001 in Pediatric Subjects With Transfusion-Dependent β-Thalassemia

Study Summary

This is a single-dose, open-label study in pediatric participants with TDT. The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (CTX001).

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Interventions

CTX001BIOLOGICAL
Administered by intravenous infusion following myeloablative conditioning with busulfan.

Study Locations

FacilityCityStateCountry
TriStar Medical Group Children's Specialists - Pediatric OncologyNashvilleTennesseeUnited States
Hospital for Sick Children - HematologyTorontoCanada
University Hospital Dusseldorf - Department of Pediatric Oncology, Hematology and Clinical ImmunologyDüsseldorfGermany
IRCSS Ospedale Pediatrico Bambino Gesu - Dipartimento di Onco-Ematologia e Terapia Cellulare e GenicaRomeItaly
Great Ormond Street Hospital for ChildrenLondonUnited Kingdom
St.Mary's Hospital - Children's Clinical Research FacilityLondonUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026