Apheresis collection for chimeric antigen receptor T cell manufacturing: current practices and future directions
Keywords:
Apheresis, Peripheral blood mononuclear cells, Chimeric antigen receptor T cellAbstract
-
Downloads
References
June CH, Sadelain M. Chimeric antigen receptor therapy. N Engl J Med. 2018;379:64-73.
Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018;378:439-48.
Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396:839-52.
Munshi NC, Anderson LD Jr, 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.
Levine BL, Miskin J, Wonnacott K, Keir C. Global manufacturing of CAR T cell therapy. Mol Ther Methods Clin Dev. 2016;4:92-101.
Jogalekar MP, Rajendran RL, Khan F, Dmello C, Gangadaran P, Ahn BC. CAR T-Cell-Based gene therapy for cancers: new perspectives, challenges, and clinical developments. Front Immunol. 2022;13: 925985. doi: 10.3389/fimmu.2022.925985.
Stroncek DF, Ren J, Lee DW, Tran M, Frodigh SE, Sabatino M, et al. Myeloid cells in peripheral blood mononuclear cell concentrates inhibit the expansion of chimeric antigen receptor T cells. Cytotherapy. 2016;18:893-901.
Ghassemi S, Durgin JS, Nunez-Cruz S, Fraietta JA, Patel PR, Scholler J, et al. Reducing ex vivo culture improves the antileukemic activity of chimeric antigen receptor (CAR) T cells. Cancer Immunol Res. 2018;6:1100-9.
Szczepiorkowski ZM, Winters JL, Bandarenko N, Linenberger ML, Marques MB, Sarode R, et al. Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher. 2010;25:83-177.
Kaplan AA. A simple and accurate method for prescribing plasma exchange. ASAIO Trans. 1990;36:M597-9.
McLeod BC, Sniecinski I, Ciavarella D, Owen H, Price TH, Randels MJ, et al. Frequency of immediate adverse effects associated with therapeutic apheresis. Transfusion. 1999;39:282-8.
Lee SN, Sohn JY, Kong JH, Eom HS, Lee H, Kong SY. Comparison of Two Apheresis Systems of COBE and Optia for Autologous Peripheral Blood Stem Cell Collection. Ann Lab Med. 2017;37:327-30.
Schulz M, Bialleck H, Thorausch K, Bug G, Dünzinger U, Seifried E, et al. Unstimulated leukapheresis in patients and donors: comparison of two apheresis systems. Transfusion. 2014;54:1622-9.
Vormittag P, Gunn R, Ghorashian S, Veraitch FS. A guide to manufacturing CAR T cell therapies. Curr Opin Biotechnol. 2018;53:164-81.
Sauter CS, Senechal B, Rivière I, Ni A, Bernal Y, Wang X, et al. CD19 CAR T cells following autologous transplantation in poor-risk relapsed and refractory B-cell non-Hodgkin lymphoma. Blood. 2019;134:626-35.
Cooling L, Hoffmann S, Herrst M, Muck C, Armelagos H, Davenport R. A prospective randomized trial of two popular mononuclear cell collection techniques: increased platelet utilization with the Spectra Optia interface-managed collection method compared to the COBE Spectra auto mononuclear collection method. Transfusion. 2020;60:1495-507.
Allen ES, Stroncek DF, Ren J, Eder AF, West KA, Fry TJ, et al. Autologous lymphapheresis for the production of chimeric antigen receptor T cells. Transfusion. 2017;57:1133-41.
Tuazon SA, Li A, Gooley T, Eunson TW, Maloney DG, Turtle CJ, et al. Factors affecting lymphocyte collection efficiency for the manufacture of chimeric antigen receptor T cells in adults with B-cell malignancies. Cytotherapy. 2019;21:596-603.
Stroncek DF, Lee DW, Ren J, Sabatino M, Highfill S, Khuu H, et al. Elutriated lymphocytes for manufacturing chimeric antigen receptor T cells. J Transl Med. 2017;15:59.
Steininger PA, Strasser EF, Weiss D, Achenbach S, Zimmermann R, Eckstein R. First comparative evaluation of a new leukapheresis technology in non-cytokine-stimulated donors. Vox Sang. 2014; 106:248-55.
Weinstein R. Prevention of citrate reactions during therapeutic plasma exchange by constant infusion of calcium gluconate with the return fluid. J Clin Apher. 1996;11:204-10.
Harrer DC, Heidenreich M, Fante MA, Müller V, Haehnel V, Offner R, Burkhardt R, Herr W, Edinger M, Wolff D, Thomas S, Brosig A. Apheresis for chimeric antigen receptor T-cell production in adult lymphoma patients. Transfusion. 2022;62:1602-11.
Reinhardt P, Brauninger S, Bialleck H, Thorausch K, Smith R, Schrezenmeier H, et al. Automatic interface-controlled apheresis collection of stem/progenitor cells: results from an autologous donor validation trial of a novel stem cell apheresis device. Transfusion. 2011;51:1321-30.
Brocklebank AM, Sparrow RL. Enumeration of CD34+ cells in cord blood: a variation on a single-platform flow cytometric method based on the ISHAGE protocol. Cytometry. 2001;46:254-61.
Qayed M, McGuirk JP, Myers GD, Parameswaran V, Waller EK, Holman P, et al. Leukapheresis guidance and best practices for optimal chimeric antigen receptor T-cell manufacturing. Cytotherapy. 2022;24:869-78.
Fraietta JA, Lacey SF, Orlando EJ, Pruteanu-Malinici I, Gohil M, Lundh S, et al. Determinants of response and resistance to CD19 chimeric antigen receptor (CAR) T cell therapy of chronic lymphocytic leukemia. Nat Med. 2018;24:563-71.
Gaipa G, Tilenni M, Straino S, Burba I, Zaccagnini G, Belotti D, et al. GMP-based CD133(+) cells isolation maintains progenitor angiogenic properties and enhances standardization in cardiovascular cell therapy. J Cell Mol Med. 2010;14:1619-34.
Whaley D, Damyar K, Witek RP, Mendoza A, Alexander M, Lakey JR. Cryopreservation: an overview of principles and cell-specific considerations. Cell Transplant. 2021;30:963689721999617. doi: 10.1177/0963689721999617.
Lysák D, Kořístek Z, Gašová Z, Skoumalová I, Jindra P. Efficacy and safety of peripheral blood stem cell collection in elderly donors; does age interfere? J Clin Apher. 2011;26:9-16.
Valeri CR, Ragno G. Cryopreservation of human blood products. Transfus Apher Sci. 2006;34:271-87.
Hayakawa J, Joyal EG, Gildner JF, Washington KN, Phang OA, Uchida N, et al. 5% dimethyl sulfoxide (DMSO) and pentastarch improves cryopreservation of cord blood cells over 10% DMSO. Transfusion. 2010;50:2158-66.
Horowitz MM, Gale RP, Sondel PM, Goldman JM, Kersey J, Kolb HJ, et al. Graft-versus-leukemia reactions after bone marrow transplantation. Blood. 1990;75:555-62.
Anthias C, O'Donnell PV, Kiefer DM, Yared J, Norkin M, Anderlini P, et al. European group for blood and marrow transplantation centers with FACT-JACIE accreditation have significantly better compliance with related donor care standards. Biol Blood Marrow Transplant. 2016;22:514-9.
Gluckman E, Rocha V, Boyer-Chammard A, Locatelli F, Arcese W, Pasquini R, et al. Outcome of cord-blood transplantation from related and unrelated donors. N Engl J Med. 1997;337:373-81.
Heimfeld S. Bone marrow-derived immune cells. Handb Exp Pharmacol. 2008;182:93-106.
Hutt D, Nehari M, Munitz-Shenkar D, Alkalay Y, Toren A, Bielorai B. Hematopoietic stem cell donation: psychological perspectives of pediatric sibling donors and their parents. Bone Marrow Transplant. 2015; 50:1337-42.
Nastoupil LJ, Jain MD, Feng L, Spiegel JY, Ghobadi A, Lin Y, et al. Standard-of-care axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma: results from the US lymphoma CAR T consortium. J Clin Oncol. 2020;38:3119-28.
Garfall AL, Stadtmauer EA, Hwang WT, Lacey SF, Melenhorst JJ, Krevvata M, et al. Anti-CD19 CAR T cells with high-dose melphalan and autologous stem cell transplantation for refractory multiple myeloma. JCI Insight. 2019;4:e127684. doi: 10.1172/jci.insight.127684.
Shields CW 4th, Reyes CD, López GP. Microfluidic cell sorting: a review of the advances in the separation of cells from debulking to rare cell isolation. Lab Chip. 2015;15:1230-49.
Born J, Lange T, Hansen K, Mölle M, Fehm HL. Effects of sleep and circadian rhythm on human circulating immune cells. J Immunol. 1997;158:4454-64.
Bolan CD, Cecco SA, Wesley RA, Horne M, Yau YY, Remaley AT, et al. Controlled study of citrate effects and response to i.v. calcium administration during allogeneic peripheral blood progenitor cell donation. Transfusion. 2002;42:935-46.
Khera N, Majhail NS, Brazauskas R, Wang Z, He N, Aljurf MD, et al. Comparison of characteristics and outcomes of trial participants and nonparticipants: example of blood and marrow transplant clinical trials network 0201 trial. Biol Blood Marrow Transplant. 2015;21:1815-22.
Cieri N, Camisa B, Cocchiarella F, Forcato M, Oliveira G, Provasi E, et al. IL-7 and IL-15 instruct the generation of human memory stem T cells from naive precursors. Blood. 2013;121:573-84.
Singh AK, McGuirk JP. CAR T cells: continuation in a revolution of immunotherapy. Lancet Oncol. 2020;21:e168-e178.
Pirzada M, Altintas Z. Recent progress in optical sensors for biomedical diagnostics. Micromachines (Basel). 2020;11:356. doi: 10.3390/mi11040356.
Frey NV, Porter DL. Cytokine release syndrome with novel therapeutics for acute lymphoblastic leukemia. Hematology Am Soc Hematol Educ Program. 2016;2016:567-72.
Das RK, Vernau L, Grupp SA, Barrett DM. Naïve T-cell deficits at diagnosis and after chemotherapy impair cell therapy potential in pediatric cancers. Cancer Discov. 2019;9:492-9.
Maus MV, Nikiforow S. The why, what, and how of the new FACT standards for immune effector cells. J Immunother Cancer. 2017;5:36.
Dandoy CE, Adams J, Artz A, Bredeson C, Dahi PB, Dodd T, et al. In Pursuit of Optimal Outcomes: A Framework for Quality Standards in Immune Effector Cell Therapy. Transplant Cell Ther. 2024;30:942-54.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Journal of Hematology and Transfusion Medicine
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
