FDA lifts clinical hold on Gilead's CAR-T as Arcellx sheds light on reason for patient death

Gilead Sciences' $225 million bet on Arcellx’s CAR-T cell therapy is back in play after the FDA lifted a clinical hold instigated in the wake of a patient death.

The trial pause has been very short, with the regulator only implementing the hold on the iMMagine-1 study in June. At the time, Arcellx said it believed a contributing factor in the fatality had been “limitations on bridging therapy,” a term for the treatments given in the period between the T cells being removed from a patient’s body and the CAR-T being infused.