Gilead places partial clinical hold on two KITE-753 CAR-T trials in diffuse large B-cell lymphoma

Gilead announced on its third-quarter earnings call that it has placed a partial clinical hold on two CAR-T trials for KITE-753 targeting diffuse large B-cell lymphoma (DLBCL).

The hold affects the phase 2 PALISADES-1 (second-line) and phase 3 PALISADES-2 (third-line/relapsed/refractory) studies, and is intended to review safety differences observed between earlier phases.

Gilead said the decision follows identification of higher rates of grade 3 and grade 4 ICANS, a neurotoxicity syndrome, though no deaths or grade-5 events have been reported.

The company is working with the FDA to assess the data; the trials were originally part of Gilead’s 2017 acquisition of Kite Pharma.