Chimeric Antigen Receptor (CAR) T cell technology has come into fire recently after 3 patient deaths due to severe cerebral edema in Juno Therapeutics’ pivotal ROCKET trial of JCAR015 in relapse/refractory (r/r) adult (ALL). The management attributed the severe neurotoxicity to fludarabine preconditioning (which is well-known to cause severe neurotoxicity). After discussion with FDA, the company will proceed with only cyclophosphamide preconditioning before infusion of T cells in this trial.
