Af­ter pa­tient death, FDA slaps clin­i­cal hold on ear­ly-stage AML tri­al study­ing 2sev­en­ty bio as­set

A Seat­tle Chil­dren’s Hos­pi­tal-led tri­al study­ing 2sev­en­ty bio’s CD33-tar­get­ed CAR-T cell ther­a­py, SC-DAR­IC33, in acute myeloid leukemia has been put on clin­i­cal hold by the FDA. The study was paused in June af­ter a pa­tient death.

“We need to hear more from the FDA in terms of their spe­cif­ic con­cerns,” CEO Nick Leschly said this morn­ing dur­ing its sec­ond-quar­ter earn­ings call with in­vestors, adding that the Phase I tri­al hold was ex­pect­ed. The hos­pi­tal re­ceived the FDA’s of­fi­cial no­tice on Aug. 11 via email.

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