NCT05329649

A Phase 3 Study to Evaluate the Safety and Efficacy of a Single Dose of CTX001 in Pediatric Subjects With Severe Sickle Cell Disease

Study Summary

This is a single-dose, open-label study in pediatric participants with severe SCD and hydroxyurea (HU) failure or intolerance. 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
Levine Children's Hospital - HematologyCharlotteNorth CarolinaUnited States
The Children's Hospital of Philadelphia - HematologyPhiladelphiaPennsylvaniaUnited States
St. Jude Children's Research HospitalMemphisTennesseeUnited States
TriStar Medical Group Children's Specialists - Pediatric OncologyNashvilleTennesseeUnited States
University Hospital Duesseldorf - Department of Pediatric Oncology, Hematology and Clinical ImmunologyDüsseldorfGermany
IRCSS Ospedale Pediatrico Bambino Gesu - Dipartimento di Onco-Ematologia e Terapia Cellulare e GenicaRomeItaly
St.Mary's Hospital - Haematology DeptLondonUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

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