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Article History

Accepted: 9 August 2024

First Online: 6 September 2024

Declarations

:

: Magali Chartier, Thomas Peyret, Andre Ndi, Michael Dodds, and Stephen Duffull are paid consultants of Certara. Manoj Chiney, Francesca Milletti, Justin Budka, Jinghui Dong, Saran Vardhanabhuti, Daqin Mao, Rhine Shen, and Simone Filosto are employees of Kite Pharma. This research was funded by Kite Pharma, Santa Monica, CA, USA.

: Stephen Duffull is an Editorial Board member of <i>Clinical Pharmacokinetics</i>, and was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Simone Filosto, Francesca Milletti, Justin Budka, Jinghui Dong, Saran Vardhanabhuti; Daqin Mao Saran Vardhanabhuti; Daqin Mao, and Rhine Shen are employees of Kite, A Gilead Company. Manoj Chiney is employee of Gilead Sciences. Magali Chartier, Thomas Peyret, Stephen Duffull, Michael Dodds and Andre Ndi are employees of Certara.

: All studies were conducted in accordance with the 1964 Declaration of Helsinki, the general principles stated in the International Ethical Guidelines for Biomedical Research Involving Human Patients, guidelines for Good Clinical Practice as well as with applicable national or regional regulatory requirements. The trials were registered under the numbers NCT02348216, NCT03105336, and NCT03391466.

: All patients analyzed in this study provided written informed consent.

: All authors provided consent for publication.

: All data used in the analysis were obtained from Kite, a Gilead Company. Gilead Sciences shares anonymized individual patient data upon request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting no conflict of interest. The request proposal must also include a statistician. Approval of such requests is at Gilead Science’s discretion and is dependent on the nature of the request, the merit of the research proposed, the availability of the data, and the intended use of the data. Data requests should be sent to datarequest@gilead.com.

: The final model code is provided in the supplementary material.

: MC, TP, AN, MD, and SD contributed to the study conception and design of the population pharmacokinetic modeling. SF, RS, MC, FM, JB, JD, SV, and DM, contributed to the conception and design of the clinical trials. The population pharmacokinetic analysis was performed by MC and supervised by TP and MD. The dataset construction was performed by AN. The manuscript was written by MC. All authors reviewed and edited the manuscript.