Principal Scientist Johnson and Johnson Collegeville, Pennsylvania
Dose-exposure-response relationship and factors impacting PK/PD for cellular therapies such as CAR-Ts is complex. Besides, there is no industry-wide consensus on approaches to select doses for First-in-Human clinical trials for CAR-Ts. Here, mechanistic PK/PD modeling and simulation (M&S) approaches can help in better understanding of PK/PD and dose selection/optimization for CAR-T products. In this session, we will discuss cellular kinetics (PK) of CAR-Ts, PK/PD relationship observed in clinical studies, and factors impacting. We will also discuss dose selection and clinical study design considerations and introduce the concept of “threshold dose”. Finally, the utility of mechanistic modeling approaches to better understand PK/PD and support dose selection or optimization for CAR-Ts will also be discussed.
Learning Objectives:
To discuss cellular kinetics (PK) of CAR-Ts, PK/PD relationship observed in clinical studies, and factors impacting
To discuss dose selection and clinical study design considerations and introduce the concept of “threshold dose”
To discuss the utility of mechanistic PK/PD modeling approaches to better understand PK/PD of CAR-Ts and support dose selection or optimization
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