FDA gives Cel­lec­tis a green light to re­launch off-the-shelf CAR-T stud­ies — with sev­er­al strings at­tached

Two months af­ter the FDA forced Cel­lec­tis $CLLS to hit the brakes on a pair of clin­i­cal tri­als for their off-the-shelf CAR-T UCART123, reg­u­la­tors have fol­lowed up with a green light to re­sume test­ing. But they’re adding some key safe­ty mea­sures to try to re­duce any out­stand­ing risks for pa­tients in these high pro­file stud­ies.

The tri­al halt came on the death of the first pa­tient dosed with UCART123. Now in­ves­ti­ga­tors can be­gin again. But there are some ex­tra­or­di­nary strings that are now at­tached:

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