The cause of the death “and its potential relationship to the study drug” is being investigated, according to a June 14 news release from the Cambridge, Mass.-based drug company. The FDA has been notified.
The paused study is a phase 1 trial of SC-DARIC33 in acute myeloid leukemia, and it’s the first study of the DARIC T-cell platform involving humans. The patient died after receiving the second dose level of the treatment, according to the release.
“Importantly, I’d like to offer that our thoughts are with the family during this time,” Steve Bernstein, MD, chief medical officer of 2seventy Bio, said. “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.”
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