Up­dat­ed: FDA gives Cel­lec­tis all clear af­ter pa­tient death halt­ed off-the-shelf CAR-T tri­al

Four months af­ter a pa­tient death forced Cel­lec­tis to halt one of their off-the-shelf CAR-T tri­als, the FDA has giv­en them the OK to start dos­ing pa­tients again.

The Paris-based biotech said they changed the study’s pro­to­col to ac­com­mo­date the agency’s con­cerns, al­though they will still have to work with in­ves­ti­ga­tors to ob­tain lo­cal ap­proval to restart the tri­al and start re­cruit­ing pa­tients again. Pri­or its halt, the Phase I had sites in New York, New Jer­sey and Texas.

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