Gilead puts two KITE-753 CAR-T trials on partial hold

Gilead has placed a partial clinical hold, aligned with the FDA, on the phase 2 PALISADES-1 and phase 3 PALISADES-2 trials of its KITE-753 CAR-T therapy in large B-cell lymphoma, to investigate grade 3 and 4 neurotoxicity seen in a small number of patients.

Why it matters: KITE-753 is Kite's next-generation lymphoma candidate at a moment when cell therapy is Gilead's weak spot, with third quarter cell therapy sales down 18 percent to $355 million, and a safety pause in the two pivotal trials delays the programme that was meant to succeed Yescarta.

Data as of Fierce Biotech, October 30, 2026, read in full in this run, reporting Gilead's third quarter earnings call of October 29, 2026 and a company spokesperson's confirmation. Single trade-press source for the hold details; the underlying statements are the company's own, made on its earnings call.

Gilead Sciences has placed a partial clinical hold on two trials of KITE-753, its anti-CD19/CD20 CAR-T cell therapy in diffuse large B-cell lymphoma, the company said on its third quarter earnings call on October 29. The held studies are the phase 2 second-line PALISADES-1 and the phase 3 PALISADES-2 in third-line and later relapsed or refractory disease. A spokesperson told Fierce Biotech that after an initial voluntary pause the company aligned with the FDA on the partial hold to review the safety data.

Chief medical officer Dietmar Berger said the trials were paused to investigate safety differences noted between phase 1 and phase 2, and Kite head Cindy Perettie pointed specifically to grade 3 and grade 4 ICANS, the immune effector cell neurotoxicity syndrome, emerging in a small number of patients. Perettie said there were no deaths and no grade 5 adverse events. No restart date was given.

Gilead puts two KITE-753 CAR-T trials on partial hold

Sources