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Keywords: CAR-T cell therapies; cellular kinetics; exposure-response models; fixed and body-weight-based dosing EN CAR-T cell therapies cellular kinetics exposure-response models fixed and body-weight-based dosing 1130 1135 6 10/06/22 20221001 NES 221001 Historically, body-size-based dosing has been utilized for many anticancer drugs. For example, the CK curves of lisocabtagene maraleucel overlapped across 50, 100, and 150 million cells dose levels, and no dose-exposure or dose-efficacy relationships were identified.16 BW was not identified as a significant covariate.16 Although there was a positive trend for the E-R between CAR-T cell growth and tumor response, FDA evaluation (lisocabtagene maraleucel BLA 125714 Clinical Pharmacology Review document) suggested it should not be interpreted as causally connected between dose and response, given the observed flat dose-exposure-response relationship. At a dose of 0.5 × 10 SP 6 sp CAR-T cells/kg, the C SB max sb and AUC SB 0-28d sb of brexucabtagene autoleucel were approximately 60% of that in subjects treated at a dose of 2 × 10 SP 6 sp CAR-T cells/kg, exhibiting a potential underexposure. A Consideration of Fixed Dosing Versus Body Size-Based Dosing Strategies for Chimeric Antigen Receptor T-Cell Therapies. [Extracted from the article]