A Phase 1/2 Open Label Study Evaluating the Safety and Efficacy of Gene Therapy in Subjects With β-Thalassemia Major by Transplantation of Autologous CD34+ Cells Transduced Ex Vivo With a Lentiviral βA-T87Q-Globin Vector (LentiGlobin® BB305 Drug Product)
Phase of Trial: Phase I/II
Latest Information Update: 06 Nov 2019
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At a glance
- Drugs BB305 beta-globin gene therapy bluebird bio (Primary)
- Indications Beta-thalassaemia
- Focus Adverse reactions; Therapeutic Use
- Acronyms NorthStar
- Sponsors bluebird bio
- 06 Nov 2019 According to a Bluebird bio media release, updated efficacy and safety data will be presented at the upcoming 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida, December 7 - 10.
- 14 Jun 2019 Results presented in a bluebird bio Media Release.
- 03 Jun 2019 The European Commission (EC) has granted conditional marketing authorization for ZYNTEGLO for patients 12 years and older with transfusion-dependent beta-thalassemia for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. This approval is supported by data from HGB-205 ,HGB-204, HGB-207, HGB-212 and LTF-303 studies.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History