NCT03655678

A Phase 1/2/3 Study of the Safety and Efficacy of a Single Dose of Autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) in Subjects With Transfusion-Dependent β-Thalassemia

Study Summary

This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in participans with transfusion-dependent β-thalassemia (TDT). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001.

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Interventions

CTX001BIOLOGICAL
Administered by IV infusion following myeloablative conditioning with busulfan

Study Locations

FacilityCityStateCountry
Lucile Packard Children's HospitalPalo AltoCaliforniaUnited States
Ann & Robert Lurie Children's Hospital of ChicagoChicagoIllinoisUnited States
Columbia University Medical Center (21+ years)New YorkNew YorkUnited States
Columbia University Medical CenterNew YorkNew YorkUnited States
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
The Children's Hospital at TriStar Centennial Medical Center/ Sarah Cannon Center for Blood CancersNashvilleTennesseeUnited States
The Hospital for Sick ChildrenTorontoCanada
British Columbia Children's HospitalVancouverCanada
Universitätsklinikum Düsseldorf Hospital DuesseldorfDüsseldorfGermany
Regensburg University Hospital, Clinic and Polyclinic for Paediatric and Adolescent MedicineRegensburgGermany
University Hospital TübingenTübingenGermany
Ospedale Pediatrico Bambino Gesù, IRCCSRomeItaly
Imperial College Healthcare NHS Trust, Hammersmith HospitalLondonUnited Kingdom
University College London Hospitals NHS Foundation TrustLondonUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

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