Nonclinical research on CAR-T cell products: main concerns and key issues

doi:10.19803/j.1672-8629.2022.08.01

Abstract

Abstract: Objective To explore the main contents and key issues of non-clinical research on chimeric antigen receptor T (CAR-T) cell products, and to provide useful references for the research and development of CAR-T products. Methods According to the characteristics of CAR-T products, based on the evaluation practice of CAR-T cell products in our center, combined with the non-clinical research status of CAR-T cells at home and abroad and relevant literature reports, the research contents and main concerns of non-clinical safety evaluation of CAR-T cells were summarized. Results The latest progress and academic opinions on the selection of animal models, pharmacodynamic evaluation, toxicity study and biological distribution study in the non-clinical evaluation of CAR-T products were expounded and suggestions were put forward. Conclusion CAR-T cells, as a complex new biotherapy product, may have a variety of safety risks when used in vivo. In the non-clinical study of CAR-T cells, the design and test shall be carried out according to the product characteristics and specific conditions, in combination with relevant domestic and foreign standards, technical requirements and development trends.

Key words: chimeric antigen receptor T(CAR-T) cells, nonclinical research, animal models, toxicity, safety, efficacy

CLC Number:

R979.1

HUANG Ying, HOU Tiantian, QIN Chao, HUO Yan, WANG Sanlong, WEN Hairuo, GENG Xingchao. Nonclinical research on CAR-T cell products: main concerns and key issues[J]. Chinese Journal of Pharmacovigilance, 2022, 19(8): 813-816.

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