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Single Patient Safety Concern Hits Allogene’s Off-The-Shelf CAR-T

All Of Company’s Trials Halted

 
• By Andrew McConaghie

Allogene is the frontrunner in the allogeneic CAR-T field but must assess whether or not its therapy could have caused a patient’s unexpected chromosomal abnormality.

Allogene building
The first autologous CAR-Ts gained approval in 2017, but the wait for the first allogeneic version goes on.

All of Allogene Therapeutics’ off-the-shelf CAR T therapy trials have been placed on hold by the US Food and Drug Administration after a single patient experienced a chromosomal abnormality following treatment, sending the company’s share price plunging by 42%.

The decision is another sign of the US regulator’s caution in cell and gene therapy studies and follows a string of other clinical holds and investigations in the space.

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