FDA presents details on CAR T safety database

At an EMA workshop on Wednesday, FDA presented details about how it is collecting data about chimeric antigen receptor T cell and T cell receptor (TCR) therapies for a safety database. FDA's Maura O'Leary said the project's objective is to assess the feasibility of systematically collecting, storing and analyzing safety data about CAR T and TCR therapies to enable cross-study and cross-IND analysis.

The project also aims to develop prediction models that can identify safety issues associated with T cell therapies, leading to the development of risk mitigation strategies. ...