A Phase I clinical trial testing a CAR-T cell therapy treatment in children with acute myeloid leukaemia (AML) has been paused due to a patient’s death.
The PLAT-08 clinical trial is a Phase I study of 2seventy bio’s cell therapy SC-DARIC33 in patients with AML. The study was paused by the company’s partner and sponsor of the trial, Seattle Children’s Therapeutic, due to a Grade 5 (fatal) serious adverse event (SAE).
The Food and Drug Administration (FDA) has been notified and the cause of the SAE is currently under investigation. The SAE occurred in the first patient treated with SC-DARIC33 at the second dose.
Steve Bernstein, M.D., Chief Medical Officer of 2seventy bio said: “Importantly, I’d like to offer that our thoughts are with the family during this time. The safety of every patient who participates in our studies or is treated with our therapies is the utmost priority for us, and we are in communication with FDA while we assess the data surrounding this SAE, and the potential next steps for the study.”
