NCT03207009

A Phase 3 Single Arm Study Evaluating the Efficacy and Safety of Gene Therapy in Subjects With Transfusion-dependent β-Thalassemia by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a Lentiviral βA-T87Q-Globin Vector in Subjects ≤50 Years of Age

Study Summary

This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 18 participants less than or equal to (\<=) 50 years of age with transfusion-dependent β-thalassemia (TDT), who have a β0/β0, β0/IVS-I-110, or IVS-I-110/IVS-I-110 genotype. The study will evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product.

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Interventions

LentiGlobin BB305 Drug ProductGENETIC
LentiGlobin BB305 Drug Product is administered by IV infusion following myeloablative conditioning with busulfan.

Study Locations

FacilityCityStateCountry
UCSF Benioff Children's Hospital OaklandOaklandCaliforniaUnited States
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinoisUnited States
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Hopital d'enfants de la TimoneMarseilleFrance
Hannover Medical SchoolHanoverGermany
University of HeidelbergHeidelbergGermany
General Hospital of Thessaloniki 'G.Papanikolaou'ThessalonikiGreece
IRCCS Ospedale Pediatrico Babino GesuRomeItaly
University College London HospitalLondonUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

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