Nonclinical immunotoxicity evaluation of CAR-T cell products

doi:10.19803/j.1672-8629.20230134

Abstract

Abstract: Objective Analysis of nonclinical immunotoxicity of CAT-T cell products, in order to provide a reference for safe clinical use. Methods The current research on CAR-T was outlined. The principles, characteristics, priorities of research, and immune-related toxicity of CAR-T products were analyzed based on related guidelines and immunotoxicity tests. Results The guidelines for evaluating the immunotoxicity of different types of CAR-T were inadequate. Currently, immunotoxicity tests were usually integrated into standard toxicity tests for initial screening before corresponding immune functional tests were selected as additional tests based on the results. TDAR was a preferable method for the overall evaluation of CAR-T immune toxicity. Conclusion There is a lack of appropriate evaluation strategies for the immunotoxicity evaluation of CAR-T cell products.

Key words: chimeric antigen receptor T, immunotoxicity, cytokine release syndrome, integrated strategy, animal models, T cell dependent antibody response

CLC Number:

R994.1

LIU Chang, SHI Chang, YIN Jiye. Nonclinical immunotoxicity evaluation of CAR-T cell products[J]. Chinese Journal of Pharmacovigilance, 2024, 21(9): 1051-1055.

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https://zgywjj.magtechjournal.com/EN/Y2024/V21/I9/1051

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