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Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing

Chimeric antigen receptor T-cells targeting the CD19 antigen have achieved impressive results in patients with relapsed/refractory (R/R) B-cell malignancies, leading to their approval in the European Union and other jurisdictions. In Spain, the 100% academic anti-CD19 CART-cell product varnimcabtage...

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Autores principales: Martinez-Cibrian, Nuria, Español-Rego, Marta, Pascal, Mariona, Delgado, Julio, Ortiz-Maldonado, Valentín
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9550897/
https://www.ncbi.nlm.nih.gov/pubmed/36238283
http://dx.doi.org/10.3389/fimmu.2022.1005457
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author Martinez-Cibrian, Nuria
Español-Rego, Marta
Pascal, Mariona
Delgado, Julio
Ortiz-Maldonado, Valentín
author_facet Martinez-Cibrian, Nuria
Español-Rego, Marta
Pascal, Mariona
Delgado, Julio
Ortiz-Maldonado, Valentín
author_sort Martinez-Cibrian, Nuria
collection PubMed
description Chimeric antigen receptor T-cells targeting the CD19 antigen have achieved impressive results in patients with relapsed/refractory (R/R) B-cell malignancies, leading to their approval in the European Union and other jurisdictions. In Spain, the 100% academic anti-CD19 CART-cell product varnimcabtagene autoleucel (var-cel, ARI-0001 cells) has been extraordinarily approved under the Hospital Exemption clause for the treatment of patients older than 25 years of age with R/R acute lymphoblastic leukaemia. Var-cel has also been granted PRIority MEdicines designation by the European Medicines Agency for the same indication. In this review we reveal some practical aspects related to the preparation and administration of academic point-of-care CART-cell products, using var-cel as an example, and put them into the context of commercial products.
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spelling pubmed-95508972022-10-12 Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing Martinez-Cibrian, Nuria Español-Rego, Marta Pascal, Mariona Delgado, Julio Ortiz-Maldonado, Valentín Front Immunol Immunology Chimeric antigen receptor T-cells targeting the CD19 antigen have achieved impressive results in patients with relapsed/refractory (R/R) B-cell malignancies, leading to their approval in the European Union and other jurisdictions. In Spain, the 100% academic anti-CD19 CART-cell product varnimcabtagene autoleucel (var-cel, ARI-0001 cells) has been extraordinarily approved under the Hospital Exemption clause for the treatment of patients older than 25 years of age with R/R acute lymphoblastic leukaemia. Var-cel has also been granted PRIority MEdicines designation by the European Medicines Agency for the same indication. In this review we reveal some practical aspects related to the preparation and administration of academic point-of-care CART-cell products, using var-cel as an example, and put them into the context of commercial products. Frontiers Media S.A. 2022-09-27 /pmc/articles/PMC9550897/ /pubmed/36238283 http://dx.doi.org/10.3389/fimmu.2022.1005457 Text en Copyright © 2022 Martinez-Cibrian, Español-Rego, Pascal, Delgado and Ortiz-Maldonado https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Immunology
Martinez-Cibrian, Nuria
Español-Rego, Marta
Pascal, Mariona
Delgado, Julio
Ortiz-Maldonado, Valentín
Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing
title Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing
title_full Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing
title_fullStr Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing
title_full_unstemmed Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing
title_short Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing
title_sort practical aspects of chimeric antigen receptor t-cell administration: from commercial to point-of-care manufacturing
topic Immunology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9550897/
https://www.ncbi.nlm.nih.gov/pubmed/36238283
http://dx.doi.org/10.3389/fimmu.2022.1005457
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