After a Massachusetts drug company paused its phase 1 study of a leukemia drug candidate in June following a study participant's death, the FDA put a clinical hold on the trial Aug. 11.
The study is the first to test the DARIC T-cell platform in humans. The subject died after receiving the second dose level of the investigative treatment for acute myeloid leukemia, and after the research was paused, an internal investigation was launched.
"This investigation provided insights into the potential pathobiology of this toxicity which led to several study protocol changes, which the team believes may mitigate this toxicity and allow for the continuation of the PLAT-08 study," Cambridge, Mass.-based 2seventy Bio said in an Aug. 14 news release.
2seventy Bio and its sponsor, Seattle Children's Hospital, are working to determine the root cause of the death and amend protocol. After reviewing its protocol revisions, the trial sponsors said they hope to resume the study.