Quality Control and Nonclinical Research on CAR-T Cell Products:General Principles and Key Issues

摘要

Adoptive cell therapy using chimeric antigen receptor T (CAR-T) cells,which is a promising cancer immunotherapy strategy,has been developing very rapidly in recent years.CAR-T cells are genetically modified T cells that can specifically recognize tumor specific antigens on the surface of tumor cells,and then effectively kill tumor cells.At present,exciting results are being achieved in clinical applications of CAR-T cells for patients with hematological malignancies.The research and development of CAR-T cells for various targets and for the treatment of solid tumors have become a hot topic worldwide,so an increasing number of investigational new drug applications (INDAs) and new drug applications (NDAs)of CAR-T cell products are expected to be submitted in future.The quality control and nonclinical research of these products are of great significance in ensuring the safety and effectiveness of these products;however,they also present great challenges and difficulties.This article discusses the general principles of and key issues regarding the quality control and nonclinical research of CAR-T cell products based on their product characteristics and on relevant guidelines for gene and cell therapy products.