The main purpose of long-term follow-up of CAR-T cell therapy products is to collect patients’ delayed adverse reactions, understand the survival of the product in the body, and observe changes in efficacy over time, so as to identify and reduce the risk of patients receiving CAR-T cell therapy products. Long-term risks can help evaluate the benefits and risks of a product. This document provides technical guidance on long-term follow-up clinical studies of autologous CAR-T cell therapy products in terms of factors to consider and the design and implementation of long-term follow-up studies to ensure timely collection of signals of delayed adverse reactions and to identify and reduce such risks.
T/SHPPA 023-2023 history
2023T/SHPPA 023-2023 Long term follow-up study guidance for CAR-T cell therapy products