Advanced search
Publication Cover
Expert Opinion on Biological Therapy Volume 17, 2017 - Issue 6
Submit an article Journal homepage
7,566
Views
12
CrossRef citations to date
0
Altmetric
Editorial

Regulatory challenges and considerations for the clinical application of CAR-T cell anti-cancer therapy

Frederick L. LockeDepartment of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA;Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, FL, USACorrespondence[email protected]
View further author information
&
Marco L. DavilaDepartment of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA;Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, FL, USACorrespondence[email protected]
View further author information
Pages 659-661 | Received 21 Feb 2017, Accepted 21 Apr 2017, Published online: 09 May 2017

References

  • Sadelain M, Brentjens R, Riviere I. The basic principles of chimeric antigen receptor design. Cancer Discov. 2013 Apr;3(4):388–398.
  • Abate-Daga D, Davila ML. CAR models: next-generation CAR modifications for enhanced T-cell function. Mol Ther Oncolytics. 2016;3:16014.
  • Maus MV, Fraietta JA, Levine BL, et al. Adoptive immunotherapy for cancer or viruses. Annu Rev Immunol. 2014;32:189–225.
  • Davila ML, Riviere I, Wang X, et al. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Sci Transl Med. 2014 Feb 19;6(224):224ra25.
  • Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014 Oct 16;371(16):1507–1517.
  • Lee DW, Kochenderfer JN, Stetler-Stevenson M, et al. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517–528.
  • Turtle CJ, Hanafi LA, Berger C, et al. CD19 CAR-T cells of defined CD4+: CD8+composition in adult B cell ALL patients. J Clin Invest. 2016 Apr 25;126:2123–2138.
  • Kochenderfer JN, Dudley ME, Kassim SH, et al. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015 Feb 20;33(6):540–549.
  • Locke FL, Neelapu SS, Bartlett NL, 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. 2017 Jan 04;25(1):285–295.
  • Oluwole OO, Davila ML. At the bedside: clinical review of chimeric antigen receptor (CAR) T cell therapy for B cell malignancies. J Leukoc Biol. 2016 Jun 27;100:1265–1272.
  • Kwok M, Foster T, Steinberg M. Expedited programs for serious conditions: an update on breakthrough therapy designation. Clin Ther. 2015 Sep;37(9):2104–2120.
  • Grupp SA, Laetsch TW, Buechner J, et al. Analysis of a global registration trial of the efficacy and safety of CTL019 in pediatric and young adults with relapsed/refractory acute lymphoblastic leukemia (ALL). Blood. 2016;128(22):221.
  • DeFrancesco L. CAR-T’s forge ahead, despite Juno deaths. Nat Biotechnol. 2017 Jan 10;35(1):6–7.
  • Neelapu SS, Locke FL, Bartlett NL et al. Kte-C19 (anti-CD19 CAR T Cells) induces complete remissions in patients with refractory diffuse large B-cell lymphoma (DLBCL): results from the pivotal phase 2 ZUMA-1. Blood 128, no. 22 (2016): LBA-6.
  • Hacein-Bey-Abina S, Von Kalle C, Schmidt M, et al. LMO2-associated clonal T cell proliferation in two patients after gene therapy for SCID-X1. Science. 2003 Oct 17;302(5644):415–419.
  • Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188–195.
  • Maus MV, Nikiforow S. The Why, what, and How of the New FACT standards for immune effector cells. J Immunother Cancer 2017;5:36.
  • Clyde AT, Bockstedt L, Farkas JA, et al. Experience with Medicare’s new technology add-on payment program. Health Aff (Millwood). 2008 Nov-Dec;27(6):1632–1641.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.