Bluebird bio, Inc. announced yesterday that the first subject with β-thalassemia major has been enrolled in its phase 1/2 Northstar Study (HGB-204) in the United States and has undergone infusion with bluebird bio’s LentiGlobin drug product in an autologous hematopoietic stem cell transplantation.
The phase 1/2 study is designed to evaluate the feasibility, safety and efficacy of LentiGlobin (BB305) drug product in the treatment of subjects with beta-thalassemia major. The study is designed to enroll up to fifteen subjects. Subjects will be evaluated for safety and efficacy post-transplant.
More information: bluebird bio website and announcement, Northstar study website, Clinical trial