Servi­er, Pfiz­er get FDA OK to start US test­ing of an off-the-shelf CAR-T from Cel­lec­tis

Just a month af­ter the FDA signed off on the first US study for an off-the-shelf CAR-T ther­a­py from Cel­lec­tis $CLLS, its part­ners at Servi­er and Pfiz­er $PFE now have a green light to be­gin treat­ing pa­tients in the US with UCART19, an al­lo­gene­ic ther­a­py for acute lym­phoblas­tic leukemia.

Servi­er and Pfiz­er have a deal to co-de­vel­op UCART19, ini­tial­ly launch­ing their Phase I CALM tri­al in the UK last sum­mer in CD19-pos­i­tive B-cell ALL. Now they can be­gin treat­ing pa­tients at a num­ber of US cen­ters, in­clud­ing the MD An­der­son Can­cer Cen­ter in Hous­ton, a hotbed of can­cer drug re­search.

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