| Zynteglo (betibeglogene autotemcel) / bluebird bio |
2019-004266-18: 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 |
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| Not yet recruiting | 3 | 52 | Europe | LentiGlobin BB305 Drug Product (autologous CD34 cells transduced w/ BB305 lentiviral vector), Dispersion for infusion | bluebird bio, Inc., bluebird bio, Inc. (with its wholly owned subsidiary bluebird bio (Netherlands) B.V.) | Subjects with sickle-cell disease treated with gene therapy drug products in a bluebird bio-sponsored study will be invited to participate in this long-term follow-up study to monitor the safety and efficacy of the drug products., Sickle-cell disease, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
| Completed | 3 | 19 | Europe, US | LentiGlobin BB305 Drug Product, betibeglogene autotemcel | bluebird bio | Beta-Thalassemia | 11/22 | 11/22 | | |
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| Active, not recruiting | 3 | 35 | US | bb1111, lovotibeglogene autotemcel, lovo-cel, LentiGlobin BB305 Drug Product for SCD, autologous CD34+ cell-enriched population from patients with SCD that contains HSCs transduced with BB305 LVV encoding the βA-T87Q-globin gene, suspended in cryopreservation solution | bluebird bio | Sickle Cell Disease | 05/27 | 11/27 | | |
2012-000695-42: Essai clinique de Phase I/II évaluant la sécurité et l’efficacité du produit de thérapie génique LentiGlobin BB305 Drug Product dans le traitement de la drépanocytose sévère et la béta-thalassémie majeure. |
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| Not yet recruiting | 1/2 | 7 | Europe | LentiGlobin BB305 Drug Product (autologous CD34 cells transduced w/ LentiGlobin BB305), Suspension for infusion | bluebird bio, Inc., bluebird bio, Inc. (with its wholly owned subsidiary bluebird bio France) | Severe sickle cell anemia and transfusion-dependent beta-thalassemia major. This study will enroll patients who are eligible for an allogeneic hematopoietic stem cell transplant (HSCT) but do not have a suitable, willing human leukocyte antigen (HLA)-identical sibling donor., beta-thalassemia major and severe sickle cell anemia beta-thalassemie majeure et drepanocytose severe, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
HGB-206, NCT02140554: A Study Evaluating the Safety and Efficacy of Lovo-cel in Severe Sickle Cell Disease |
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| Completed | 1/2 | 54 | US | lovo-cel, lovotibeglogene autotemcel, bb1111, LentiGlobin BB305 Drug Product for SCD, autologous CD34+ cell-enriched population with SCD that contains HSCs and PSCs transduced with BB305 lentiviral vector encoding the βA-T87Q-globin gene, suspended in cryopreservation solution. | bluebird bio | Sickle Cell Disease | 07/23 | 01/24 | | |
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NCT06271512: A Study of Participants with Β-Thalassemia Treated with Betibeglogene Autotemcel |
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| Recruiting | N/A | 150 | US | No Intervention | bluebird bio, Center for International Blood and Marrow Transplant Research | Beta-Thalassemia | 12/43 | 12/43 | | |
| Active, not recruiting | N/A | 66 | Europe, US, RoW | Safety and efficacy assessments | bluebird bio | Transfusion-dependent Beta-Thalassemia | 11/35 | 11/35 | | |
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