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Characterization of clinical grade CD19 chimeric antigen receptor T cells produced using automated CliniMACS prodigy system

Authors Zhang W, Jordan KR, Schulte B, Purev E

Received 24 May 2018

Accepted for publication 9 August 2018

Published 5 October 2018 Volume 2018:12 Pages 3343—3356


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Dr Qiongyu Guo

Wei Zhang,1 Kimberly R Jordan,2 Brian Schulte,3 Enkhtsetseg Purev1

1Division of Hematology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; 2Division of Immunology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; 3Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

Background: Chimeric antigen receptor (CAR) T-cell therapy is highly effective for treating acute lymphoblastic leukemia and non-Hodgkin’s lymphoma with high rate complete responses. However, the broad clinical application of CAR T-cell therapy has been challenging, largely due to the lack of widespread ability to produce and high cost of CAR T-cell products using traditional methods of production. Automated cell processing in a closed system has emerged as a potential method to increase the feasibility of producing CAR T cells locally at academic centers due to its minimal reliance on experienced labor, thereby making the process less expensive and more consistent than traditional methods of production.
Method: In this study, we describe the successful production of clinical grade CD19 CAR T cells using the Miltenyi CliniMACS Prodigy Automated Cell Processor at University of Colorado Anschutz Medical Campus in a rapid manner with a high frequent CD19 CAR expression.
Results: The final CAR T-cell product is highly active, low in immune suppression, and absent in exhaustion. Full panel cytokine assays also showed elevated production of Th1 cytokines upon IL-2 stimulation when specifically killing CD19+ target cells.
Conclusion: These results demonstrate the feasibility of producing CAR T cells locally in a university hospital setting using automated cell processor for future clinical applications.

Keywords: automated decentralized cell production, CD19, chimeric antigen receptor, immunophenotype, activation status, cytokine panel

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