Celyad gets the go-ahead to re­sume CAR-T tri­al for col­orec­tal can­cer as FDA lifts hold

Four months ago, the FDA placed a clin­i­cal hold on Celyad’s CAR-T tri­al for col­orec­tal can­cer af­ter two pa­tients died dur­ing the study. Reg­u­la­tors have now lift­ed the hold, al­low­ing the Bel­gian com­pa­ny’s tri­al to set sail once again.

On Feb. 28, Celyad an­nounced that it had “vol­un­tar­i­ly paused” the tri­al of its off-the-shelf CAR-T in com­bi­na­tion with Mer­ck’s PD-1 in­hibitor Keytru­da as it in­ves­ti­gat­ed the deaths. Both pa­tients had “pre­sent­ed with sim­i­lar pul­monary find­ings,” the com­pa­ny added with­out fur­ther ex­pla­na­tion. The FDA im­posed the hold short­ly af­ter the com­pa­ny’s an­nounce­ment.

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