A Consideration of Fixed Dosing Versus Body Size-Based Dosing Strategies for Chimeric Antigen Receptor T-Cell Therapies.

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.

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