In the news, the FDA has placed a clinical hold on two phase 1 trials of Cellectis’ (CLLS) off- the-shelf product UCART123 after the death of a 78-year old patient. Cellectis is working with the FDA towards finding ways that help mitigate the risks expected to have caused the fatality.
We experienced deaths with other CAR T products with the cytokine release syndrome on the top of the adverse effects that pose life-threatening risks that lead to hospitalization and, in some cases, to death. The difference between these CAR T therapies and Cellectis’ CAR T . . .