Point-Of-Care CAR T-Cell Production (ARI-0001) Using a Closed Semi-automatic Bioreactor: Experience From an Academic Phase I Clinical Trial.
CAR T-cell production
CD19
CliniMACS Prodigy
chimeric antigen receptor
immunotherapy
leukemia
lymphoma
Journal
Frontiers in immunology
ISSN: 1664-3224
Titre abrégé: Front Immunol
Pays: Switzerland
ID NLM: 101560960
Informations de publication
Date de publication:
2020
2020
Historique:
received:
27
09
2019
accepted:
02
03
2020
entrez:
13
6
2020
pubmed:
13
6
2020
medline:
30
3
2021
Statut:
epublish
Résumé
Development of semi-automated devices that can reduce the hands-on time and standardize the production of clinical-grade CAR T-cells, such as CliniMACS Prodigy from Miltenyi, is key to facilitate the development of CAR T-cell therapies, especially in academic institutions. However, the feasibility of manufacturing CAR T-cell products from heavily pre-treated patients with this system has not been demonstrated yet. Here we report and characterize the production of 28 CAR T-cell products in the context of a phase I clinical trial for CD19+ B-cell malignancies (NCT03144583). The system includes CD4-CD8 cell selection, lentiviral transduction and T-cell expansion using IL-7/IL-15. Twenty-seven out of 28 CAR T-cell products manufactured met the full list of specifications and were considered valid products.
Identifiants
pubmed: 32528460
doi: 10.3389/fimmu.2020.00482
pmc: PMC7259426
doi:
Banques de données
ClinicalTrials.gov
['NCT03144583']
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
482Informations de copyright
Copyright © 2020 Castella, Caballero-Baños, Ortiz-Maldonado, González-Navarro, Suñé, Antoñana-Vidósola, Boronat, Marzal, Millán, Martín-Antonio, Cid, Lozano, García, Tabera, Trias, Perpiña, Canals, Baumann, Benítez-Ribas, Campo, Yagüe, Urbano-Ispizua, Rives, Delgado and Juan.
Références
Cancer Immunol Res. 2017 Jul;5(7):571-581
pubmed: 28550091
J Clin Invest. 2015 Sep;125(9):3392-400
pubmed: 26325036
Blood. 1997 May 15;89(10):3700-7
pubmed: 9160675
Gastroenterology. 2018 Jul;155(1):29-32
pubmed: 29567081
Blood. 2016 Sep 29;128(13):1688-700
pubmed: 27412889
Mol Ther. 2010 Apr;18(4):843-51
pubmed: 20179677
Immunity. 2016 Feb 16;44(2):380-90
pubmed: 26885860
Clin Cancer Res. 2015 Jul 15;21(14):3149-59
pubmed: 25850950
Sci Transl Med. 2015 Sep 2;7(303):303ra139
pubmed: 26333935
Clin Cancer Res. 2006 Oct 15;12(20 Pt 1):6106-15
pubmed: 17062687
Cytotherapy. 2016 Aug;18(8):1002-1011
pubmed: 27378344
Blood. 2013 Dec 12;122(25):4129-39
pubmed: 24055823
Eur J Immunol. 2010 Jul;40(7):1938-49
pubmed: 20432236
N Engl J Med. 2011 Aug 25;365(8):725-33
pubmed: 21830940
N Engl J Med. 2016 Dec 29;375(26):2561-9
pubmed: 28029927
Blood. 2016 Mar 3;127(9):1117-27
pubmed: 26813675
Front Immunol. 2018 Dec 03;9:2740
pubmed: 30559740
Blood. 1994 Oct 1;84(7):2221-8
pubmed: 7919339
Front Immunol. 2018 Jul 27;9:1740
pubmed: 30140266
Transfus Med Hemother. 2019 Feb;46(1):47-54
pubmed: 31244581
N Engl J Med. 2014 Oct 16;371(16):1507-17
pubmed: 25317870
Lancet. 2015 Feb 7;385(9967):517-528
pubmed: 25319501
J Clin Invest. 2017 Sep 1;127(9):3462-3471
pubmed: 28805662
Leukemia. 2016 Feb;30(2):492-500
pubmed: 26369987
Clin Cancer Res. 2017 Mar 1;23(5):1156-1166
pubmed: 27582488
Immunol Rev. 2014 Jan;257(1):127-44
pubmed: 24329794
Leukemia. 2010 Jun;24(6):1160-70
pubmed: 20428207
Trends Mol Med. 2017 May;23(5):430-450
pubmed: 28416139
Blood. 2011 Nov 3;118(18):4817-28
pubmed: 21849486
Drug Des Devel Ther. 2018 Oct 05;12:3343-3356
pubmed: 30323566
Cell Rep. 2017 Dec 12;21(11):3205-3219
pubmed: 29241547
Blood. 2011 Jan 20;117(3):808-14
pubmed: 20971955
J Natl Cancer Inst. 2016 Jan 27;108(7):
pubmed: 26819347
Nat Med. 2018 Jan;24(1):20-28
pubmed: 29155426
J Clin Oncol. 2015 Feb 20;33(6):540-9
pubmed: 25154820
Immunol Rev. 2015 Jan;263(1):68-89
pubmed: 25510272
J Clin Invest. 2008 Jan;118(1):294-305
pubmed: 18060041
Hum Gene Ther. 2016 Oct;27(10):860-869
pubmed: 27562135
Mol Ther. 2013 Apr;21(4):904-12
pubmed: 23423337
Mol Ther Methods Clin Dev. 2018 Dec 06;12:134-144
pubmed: 30623002
Mol Ther Oncolytics. 2016 Jun 15;3:16015
pubmed: 27347557
Cancer Immunol Immunother. 2012 Aug;61(8):1269-77
pubmed: 22274776
J Clin Oncol. 2018 Aug 1;36(22):2267-2280
pubmed: 29812997
Annu Rev Med. 2014;65:333-47
pubmed: 24274181
Nat Med. 2011 Sep 18;17(10):1290-7
pubmed: 21926977
Front Immunol. 2019 Feb 01;10:38
pubmed: 30778344
Sci Transl Med. 2017 Jul 19;9(399):
pubmed: 28724573
Cell Rep. 2017 Oct 3;21(1):17-26
pubmed: 28978471
J Immunother. 2009 Feb-Mar;32(2):169-80
pubmed: 19238016
Cancer Immunol Immunother. 2018 Jul;67(7):1053-1066
pubmed: 29605883
J Clin Oncol. 2015 May 20;33(15):1688-96
pubmed: 25800760
Blood. 2016 Jun 16;127(24):2980-90
pubmed: 27118452
J Exp Med. 1996 Jan 1;183(1):249-59
pubmed: 8551228
Cancer Immunol Immunother. 2017 Nov;66(11):1425-1436
pubmed: 28660319
J Clin Oncol. 2006 May 1;24(13):e20-2
pubmed: 16648493
Blood. 2010 Nov 18;116(20):4099-102
pubmed: 20668228
Cytometry A. 2014 Jan;85(1):25-35
pubmed: 24124072
J Hematol Oncol. 2018 Dec 20;11(1):141
pubmed: 30572922