2seventy bio Announces Clinical Study Pause of PLAT-08 Trial of SC-DARIC33 in Acute Myeloid Leukemia

Author's Avatar
Jun 14, 2023

2seventy+bio%2C+Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, today announced 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. 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.