(CercleFinance.com) – Cellectis today declares that its licensed partner, Allogene Therapeutics has announced the lifting of the US Food and Drug Administration’s (FDA) suspension notice of its clinical trials.
On October 7, 2021, the FDA suspended all five Allogene clinical trials following the report of a chromosomal abnormality detected in the CAR + T ALLO-501A cells of a single patient included in the ALPHA2 clinical trial promoted by Allogene. .
Allogene announced today that investigations have established that the chromosomal abnormality is unrelated to TALEN® genome editing technology or the Allogene manufacturing process, and has no clinical significance.
‘The abnormality was not detected in any AlloCAR TTM product manufactured, nor in any other patient treated with the same lot of ALLO-501A,’ the group states.