NCT05477563

A Phase 3b Study to Evaluate Efficacy and Safety of a Single Dose of Autologous CRISPR Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (CTX001) in Subjects With Transfusion-Dependent β-Thalassemia or Severe Sickle Cell Disease

Study Summary

This is a single-dose, open-label study in participants with transfusion-dependent β-thalassemia (TDT) or severe sickle cell disease (SCD). 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 intravenous (IV) infusion following myeloablative conditioning with busulfan

Study Locations

FacilityCityStateCountry
New York Presbyterian Hospital - Morgan Stanley Children's HospitalNew YorkNew YorkUnited States
Levine Children's Hospital - HematologyCharlotteNorth CarolinaUnited States
TriStar Medical Group Children's Specialists - Pediatric OncologyNashvilleTennesseeUnited States
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
King Faisal Specialist Hospital & Research Centre - Riyadh - HematologyAl Mathar Ash ShamaliSaudi Arabia

Official Trial Information

View on ClinicalTrials.gov

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