2seventy bio’s (NASDAQ:TSVT) partner, Seattle Children’s Hospital, paused a Phase 1 CAR T-cell therapy trial for pediatric acute myeloid leukemia after a patient death.
The child was the first to receive the second dose level of 2seventy’s investigational drug-regulated CAR T-cell treatment. The therapy utilizes the company’s DARIC technology to enable “on-demand” control of the engineered T-cell responses. The Phase 1 trial is the first-in-human study of the DARIC T cell platform.
The root cause of the fatal event is under investigation. “We are in communication with FDA while we assess the data surrounding this serious adverse event, and the potential next steps for the study,” said Steve Bernstein, M.D. and CMO of 2seventy bio, said in a statement.
The trial was slated to enroll 18 patients with a primary completion date of February 2024.
