Mother leaning down touching foreheads with her son with CALD

let's recode the science

our clinical trials

Recoding is more than finding new ways to treat disease. It’s addressing anything in our industry that stands in the way of people living fully – all people. We are committed to diverse and inclusive access in our clinical trials because we believe the best way to deliver life-altering therapies is to ensure clinical research accurately, and fully, represents all those it’s intended to help. We recognize we have work to do on this journey of equity and inclusion, including recoding how we improve our own diversity, but we’re confident we can get there together. And we invite you to join the effort.
bluebird bio is conducting clinical studies of investigational gene therapies in four diseases: cerebral adrenoleukodystrophy, relapsed/refractory multiple myeloma, sickle cell disease, and transfusion-dependent β-thalassemia.

For more information, follow the links below to the study listings on clinicaltrials.gov. Medical professionals may also email us at clinicaltrials@bluebirdbio.com for more information about study participation.
 

Lenti-D


PHASE 3 STUDY
ALD-104
Evaluating the efficacy and safety of autologous CD34+ hematopoietic stem cells, transduced ex-vivo with Lenti-D lentiviral vector, for the treatment of CALD
STATUS: RECRUITING

PHASE 2/3 STUDY
Starbeam ALD-102
Evaluating safety and efficacy of Lenti-D gene therapy in patients with CALD
STATUS: ACTIVE, NOT RECRUITING

LONG-TERM FOLLOW-UP
LTF-304
Monitoring long-term safety and efficacy of Lenti-D gene therapy in patients with CALD treated in bluebird-sponsored clinical trials
STATUS: ENROLLING BY INVITATION

OBSERVATIONAL
ALD-103
Evaluating safety and efficacy of allogeneic hematopoietic stem cell transplantation in patients with CALD aged 17 or younger
STATUS: TERMINATED
 

bb21217


PHASE 1 STUDY
CRB-402
Dose-escalation and dose-expansion study of safety and efficacy of bb21217 CAR T therapy in relapsed/refractory MM
STATUS: ACTIVE, NOT RECRUITING

PHASE 1/2 STUDY
KarMMa-7
Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
STATUS: ACTIVE, NOT YET RECRUITING

LONG-TERM FOLLOW-UP
LTF-306
STUDY INITIATION PENDING, ENROLLMENT BY INVITATION
 

LentiGlobin


PHASE 1/2 STUDIES
HGB-206
Evaluating safety and efficacy of LentiGlobin gene therapy in patients with SCD
STATUS: ACTIVE, NOT RECRUITING

HGB-205
Evaluating safety and efficacy of LentiGlobin gene therapy in patients with TDT or SCD
STATUS: COMPLETE

PHASE 3 STUDY
HGB-2
10
Evaluating safety and efficacy of LentiGlobin gene therapy in patients with SCD 
STATUS:  RECRUITING

LONG-TERM FOLLOW-UP
LTF-307
Long-term Follow-up of Subjects With Sickle Cell Disease Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector
STATUS: ENROLLING BY INVITATION


LentiGlobin


PHASE 3 STUDIES
Northstar-2 HGB-207
Evaluating safety and efficacy of LentiGlobin gene therapy in patients with TDT and non-β0/β0 genotypes
STATUS: ACTIVE, NOT RECRUITING

Northstar-3 HGB-212
Evaluating safety and efficacy of LentiGlobin gene therapy in patients with TDT and a β0/β0 genotype
STATUS: ACTIVE, NOT RECRUITING

PHASE 1/2 STUDIES
Northstar HGB-204
Evaluating safety and efficacy of LentiGlobin gene therapy in patients with TDT
STATUS: COMPLETED; RESULTS

LONG-TERM FOLLOW-UP
LTF-303
Monitoring long-term safety and efficacy of LentiGlobin gene therapy in patients with TDT or SCD treated in bluebird-sponsored clinical trials
STATUS: ENROLLING BY INVITATION