2seventy bio has paused its Phase I CAR T-cell therapy trial for pediatric acute myeloid leukemia after a patient death. The trial was being conducted in partnership with Seattle Children’s, and the company's DARIC technology is used to regulate CAR T-cell responses and enable "on-demand" control of engineered T-cells. The child who died was the first to receive the second dose level of 2seventy’s investigational drug-regulated CAR T-cell treatment. The root cause of the fatal event is under investigation, and 2seventy is communicating with the FDA while assessing potential next steps for the study. While CAR T-cell therapies have shown clinical success in blood cancers, they also come with risks, as demonstrated by previous patient deaths in trials by CRISPR Therapeutics, Tmunity Therapeutics, and Celyad Oncology.
CAR-T therapy uses modified versions of patients' own immune cells to fight cancer cells. The therapy has been successful in treating some types of blood cancer but can lead to severe side effects such as cytokine release syndrome (CRS) and neurotoxicity. Patients undergoing this treatment must be closely monitored