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# Clinical Hold on Bluebird Bio Gene Therapy
- URL: https://www.fdaweb.com/clinical-hold-on-bluebird-bio-gene-therapy/
- Published: 2021-08-12T12:00:00.000Z
- Updated: 2026-09-14T17:10:20.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149930

FDA has placed a clinical hold on Bluebird Bio’s Lenti-D (elivaldogene autotemcel) after the company reported a suspected unexpected serious adverse reaction of myelodysplastic syndrome (MDS) in a trial involving the investigational gene therapy for treating cerebral adrenoleukodystrophy. The MDS event showed up in a patient in the company’s ALD-104 study, the company says, adding that current available evidence suggests that specific design features of Lenti-D likely contributed to the event. Bluebird bio says it does not expect the clinical hold to impact its programs in sickle cell disease, β-thalassemia or oncology. “Subject to resolution of the clinical hold, the company anticipates completing the submission of the rolling BLA for eli-cel in 2021,” it says.