US FDA. US prescribing information: Yescarta (axicabtagene ciloleucel). Santa Monica (CA): Kite Pharma, Inc; 2022. Available from: https://www.fda.gov/media/108377/download. Accessed 31 Jan 2023.
King AC, Orozco JS. Axicabtagene ciloleucel: the first FDA-approved CAR T-cell therapy for relapsed/refractory large B-cell lymphoma. J Adv Pract Oncol. 2019;10:878–82.
PubMed PubMed Central Google Scholar
Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, et al. Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: observations from the JULIET, ZUMA-1, and TRANSCEND trials. Am J Hematol. 2021;96:1295–312.
Article PubMed PubMed Central Google Scholar
Wang K, Wei G, Liu D. CD19: a biomarker for B cell development, lymphoma diagnosis and therapy. Exp Hematol Oncol. 2012;1:36.
Article CAS PubMed PubMed Central Google Scholar
Sadelain M, Brentjens R, Rivière I. The basic principles of chimeric antigen receptor design. Cancer Discov. 2013;3:388–98.
Article CAS PubMed PubMed Central Google Scholar
Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, et al. Phase 1 results of ZUMA-1: a multicenter study of KTE-C19 Anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther J Am Soc Gene Ther. 2017;25:285–95.
Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377:2531–44.
Article CAS PubMed PubMed Central Google Scholar
Jacobson CA, Chavez JC, Sehgal AR, William BM, Munoz J, Salles G, et al. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022;23:91–103.
Article CAS PubMed Google Scholar
Locke FL, Miklos DB, Jacobson CA, Perales M-A, Kersten M-J, Oluwole OO, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med. 2022;386:640–54.
Article CAS PubMed Google Scholar
Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1–2 trial. Lancet Oncol. 2019;20:31–42.
Article CAS PubMed Google Scholar
Neelapu SS, Jacobson CA, Ghobadi A, Miklos DB, Lekakis LJ, Oluwole OO, et al. 5-Year follow-up supports curative potential of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1). Blood. 2023; p. blood.2022018893.
Westin JR, Oluwole OO, Kersten MJ, Miklos DB, Perales M-A, Ghobadi A, et al. Survival with axicabtagene ciloleucel in large B-cell lymphoma. N Engl J Med. 2023;389:148–57.
Article CAS PubMed Google Scholar
Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014;124:188–95.
Article CAS PubMed PubMed Central Google Scholar
Sterner RC, Sterner RM. CAR-T cell therapy: current limitations and potential strategies. Blood Cancer J. 2021;11:69.
Tallantyre EC, Evans NA, Parry-Jones J, Morgan MPG, Jones CH, Ingram W. Neurological updates: neurological complications of CAR-T therapy. J Neurol. 2021;268:1544–54.
US Food and Drug Administration. Center for Biologics Evaluation and Research. Considerations for the development of chimeric antigen receptor (CAR) T cell products. Draft guidance for industry. 2022. Available from: https://www.fda.gov/media/156896/download. Accessed 2 Jul 2023.
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products. EMEA/149995/2008 rev.1.; 2018. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-safety-efficacy-follow-risk-management-advanced-therapy-medicinal-products-revision_en.pdf. Accessed 2 Jul 2023.
Locke FL, Rossi JM, Neelapu SS, Jacobson CA, Miklos DB, Ghobadi A, et al. Tumor burden, inflammation, and product attributes determine outcomes of axicabtagene ciloleucel in large B-cell lymphoma. Blood Adv. 2020;4:4898–911.
Article PubMed PubMed Central Google Scholar
Beal SL. Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn. 2001;28:481–504.
Article CAS PubMed Google Scholar
Savic RM, Karlsson MO. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J. 2009;11:558–69.
Article PubMed PubMed Central Google Scholar
Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579–86.
Strati P, Ahmed S, Furqan F, Fayad LE, Lee HJ, Iyer SP, et al. Prognostic impact of corticosteroids on efficacy of chimeric antigen receptor T-cell therapy in large B-cell lymphoma. Blood. 2021;137:3272–6.
Article CAS PubMed PubMed Central Google Scholar
Nguyen THT, Mouksassi M-S, Holford N, Al-Huniti N, Freedman I, Hooker AC, et al. Model evaluation of continuous data pharmacometric models: metrics and graphics. CPT Pharmacomet Syst Pharmacol. 2017;6:87–109.
Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011;13:143–51.
Article PubMed PubMed Central Google Scholar
Ogasawara K, Dodds M, Mack T, Lymp J, Dell’Aringa J, Smith J. Population cellular kinetics of lisocabtagene maraleucel, an autologous CD19-directed chimeric antigen receptor T-cell product, in patients with Rrlapsed/refractory large B-cell lymphoma. Clin Pharmacokinet. 2021;60:1621–33.
Article CAS PubMed PubMed Central Google Scholar
De Boer RJ, Perelson AS. Quantifying T lymphocyte turnover. J Theor Biol. 2013;327:45–87.
Article PubMed PubMed Central Google Scholar
Singh AP, Zheng X, Lin-Schmidt X, Chen W, Carpenter TJ, Zong A, et al. Development of a quantitative relationship between CAR-affinity, antigen abundance, tumor cell depletion and CAR-T cell expansion using a multiscale systems PK-PD model. MAbs. 2020;12:1688616.
Munshi NC, Anderson LD, Shah N, Madduri D, Berdeja J, Lonial S, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med. 2021;384:705–16.
Article CAS PubMed Google Scholar
Stein AM, Grupp SA, Levine JE, Laetsch TW, Pulsipher MA, Boyer MW, et al. Tisagenlecleucel model-based cellular kinetic analysis of chimeric antigen receptor-T cells. CPT Pharmacomet Syst Pharmacol. 2019;8:285–95.
Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382:1331–42.
Article CAS PubMed PubMed Central Google Scholar
Liu C, Ayyar VS, Zheng X, Chen W, Zheng S, Mody H, et al. Model-based cellular kinetic analysis of chimeric antigen receptor-T cells in humans. Clin Pharmacol Ther. 2021;109:716–27.
Article CAS PubMed Google Scholar
Mu W, Long X, Cai H, Chen C, Hu G, Lou Y, et al. A model perspective explanation of the long-term sustainability of a fully human BCMA-targeting CAR (CT103A) T-cell immunotherapy. Front Pharmacol. 2022;13: 803693.
Article CAS PubMed PubMed Central Google Scholar
Zhang Y, Li J, Lou X, Chen X, Yu Z, Kang L, et al. A prospective investigation of bispecific CD19/22 CAR T cell therapy in patients with relapsed or refractory B cell non-Hodgkin lymphoma. Front Oncol. 2021;11: 664421.
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