Gilead's Kite Pauses Two KITE-753 Lymphoma Trials After Severe Neurotoxicity Cases
- Kite partially paused the PALISADES-1 and -2 studies of KITE-753, a CD19/CD20 CAR-T for relapsed or refractory large B-cell lymphoma, after Gilead disclosed it on its Q3 call.
- The trigger was a small number of severe (grade 3-4) ICANS cases; Kite first paused voluntarily, then aligned with the FDA on a partial hold.
- Management said there were no deaths or grade 5 events, and that the safety picture in the larger trials differed from the earlier phase 1 experience.
💡 Points Based on public reports
KITE-753 was Gilead's answer to dual-target CAR-T in lymphoma, so a safety wobble hits the argument that a second antigen buys durability at no extra toxicity. The framing is carefully contained, two trials, no deaths, and the real question is whether this is a dosing or manufacturing fix or a class-level signal. Until the hold lifts, rivals with in-vivo or off-the-shelf approaches get a free talking point.
Gilead reveals partial clinical hold on 2 CAR-T cell therapy trials ↗