On June 14, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported that the Phase 1 trial of the PLAT-08 study of SC-DARIC33 in Acute Myeloid Leukemia (AML) has been paused by Seattle Children’s, the Company’s partner and the regulatory sponsor of the study (Press release, 2seventy bio, JUN 14, 2023, View Source [SID1234632695]). The pause was instituted as part of the clinical study protocol stopping rules in response to a recent Grade 5 (fatal) serious adverse event (SAE) and was followed by the required notification to the U.S. Food & Drug Administration (FDA). The root cause of this SAE and its potential relationship to the study drug is currently under investigation.

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PLAT-08 is the Phase 1 study of SC-DARIC33 in relapsed/refractory pediatric AML, conducted by Seattle Children’s, and couples 2seventy bio’s DARIC T cell platform with Seattle Children’s expertise in oncology cell therapies. This study is a first-in-human investigation of the DARIC T cell platform. The SAE occurred in the first patient treated at the second dose level in the Phase 1 trial.

"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," said Steve Bernstein, M.D., chief medical officer, 2seventy bio.