Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cel­lec­tis was slammed af­ter the mar­ket close on Mon­day as the biotech re­port­ed that the FDA de­mand­ed it hit the brakes on their MELANI-01 tri­al for their off-the-shelf cell ther­a­py UCARTCS1A af­ter one of the pa­tients in the study died of treat­ment-re­lat­ed car­diac ar­rest.

The mul­ti­ple myelo­ma pa­tient had pre­vi­ous­ly been treat­ed un­suc­cess­ful­ly with var­i­ous ther­a­pies, not­ed the biotech, and had been giv­en dose lev­el two (DL2) of their al­lo­gene­ic CAR-T.

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