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Study identifier: NCT05477563 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Evaluation of Efficacy and Safety of a Single Dose of CTX001 in Participants With Transfusion-Dependent β-Thalassemia and Severe Sickle Cell Disease

Condition: Beta-Thalassemia · Thalassemia · Hematologic Diseases  ·  Sponsor: Vertex Pharmaceuticals Incorporated

PhasePhase 3
Planned participants26
Who can joinAll sexes, 12 Years to 35 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Medical Information  ·  6173416777  ·  medicalinfo@vrtx.com

Always discuss trial participation with your own doctor first.

Locations (6)

New York Presbyterian Hospital - Morgan Stanley Children's HospitalNew York, New York, United StatesRecruiting
Levine Children's Hospital - HematologyCharlotte, North Carolina, United StatesRecruiting
TriStar Medical Group Children's Specialists - Pediatric OncologyNashville, Tennessee, United StatesRecruiting
University Hospital Dusseldorf - Department of Pediatric Oncology, Hematology and Clinical ImmunologyDüsseldorf, GermanyRecruiting
IRCSS Ospedale Pediatrico Bambino Gesu - Dipartimento di Onco-Ematologia e Terapia Cellulare e GenicaRome, ItalyRecruiting
King Faisal Specialist Hospital & Research Centre - Riyadh - HematologyAl Mathar Ash Shamali, Saudi ArabiaRecruiting

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Source record: clinicaltrials.gov/study/NCT05477563