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Bluebird stops gene therapy trials after 2 sickle cell patients develop cancer

February 16, 2021

Bluebird bio has suspended two clinical trials of its sickle cell disease gene therapy after participants developed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). During the pause, bluebird will evaluate whether the BB305 lentiviral vector is linked to the cases of AML and MDS.

The AML case involves a patient who was received LentiGlobin gene therapy for sickle cell disease in a phase 1/2 clinical trial more than five years ago. It is currently unclear whether the development of AML is linked to the BB305 lentiviral vector used in bluebird’s gene therapy.

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