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. 2021 Mar 24;10(4):362–376. doi: 10.1002/psp4.12598

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© 2021 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

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Observed and model fitted profiles for clinical pharmacokinetic (PK)‐pharmacodynamic (PD) profiles for anti‐B‐cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy (bb2121). (a) Blood transgene level: Observed mean data (symbols), standard deviation (error bars), and model‐generated (solid lines) profiles of CAR transgene copies/ $μ$ g genomic DNA over time. (b) soluble BCMA: Observed mean data (symbols), standard deviation (error bars), and model‐generated (solid lines) profiles of percentage of change from baseline of soluble BCMA concentration over time. (c) Serum M‐protein: Observed mean data (symbols), standard deviation (error bars), and model‐generated (solid lines) profiles of percentage of change from baseline of M‐protein concentration over time following 50 × 10⁶, 150 × 10⁶, 450 × 10⁶, and 800 × 10⁶ doses of CAR‐T infusion in patients with relapsed/refractory multiple myeloma.