Massachusetts-based 2seventy bio has paused an early stage trial of a CAR T-cell therapy in acute myeloid leukemia, following the death of a young patient.
2seventy, which was spun off from bluebird bio in 2021, 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.
SC-DARIC33 is an investigational CD33-targeted CAR T-cell therapy that utilizes 2seventy bio’s proprietary Dimerizing Agent Regulated Immunoreceptor Complex (DARIC) T-cell platform, a drug regulatable CAR T-cell technology. This paused study is a first-in-human investigation of the DARIC T-cell platform.
AML is a rare but aggressive type of bone marrow cancer with limited treatment options. The investigation therapy relies on the hypothesis that a pharmacologically regulated CAR can enable potent AML targeting while limiting toxicities associated with normal myeloid and myeloid progenitor cell targeting.
2seventy says it is in communication with FDA in order to assess the data surrounding the fatal event, as well as the potential next steps for the study.