CAR-T cell manufacturing: Major process parameters and next-generation strategies

被引:89
作者
Ayala Ceja, Melanie [1 ]
Khericha, Mobina [1 ]
Harris, Caitlin M. [1 ]
Puig-Saus, Cristina [2 ,3 ,4 ]
Chen, Yvonne Y. [1 ,3 ,4 ,5 ]
机构
[1] Univ Calif Los Angeles, Dept Microbiol Immunol & Mol Genet, Los Angeles, CA 90095 USA
[2] Univ Calif Los Angeles, Dept Med, Los Angeles, CA USA
[3] Univ Calif Los Angeles, Jonsson Comprehens Canc Ctr, Los Angeles, CA 90095 USA
[4] Univ Calif Los Angeles, Parker Inst Canc Immunotherapy Ctr, Los Angeles, CA 90095 USA
[5] Univ Calif Los Angeles, Dept Chem & Biomol Engn, Los Angeles, CA 90095 USA
关键词
CENTRAL MEMORY; IN-VIVO; LISOCABTAGENE MARALEUCEL; HEMATOPOIETIC STEM; SLEEPING-BEAUTY; SITE SELECTION; RECEPTOR; THERAPY; CD8(+); CD4(+);
D O I
10.1084/jem.20230903
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
The success of CAR-T cell therapies is dependent on effective cell manufacturing that impacts product safety, efficacy, and patient accessibility. Here, we discuss major process parameters of autologous CAR-T cell manufacturing, regulatory considerations, and emerging technologies in therapeutic cell manufacturing. Chimeric antigen receptor (CAR)-T cell therapies have demonstrated strong curative potential and become a critical component in the array of B-cell malignancy treatments. Successful deployment of CAR-T cell therapies to treat hematologic and solid cancers, as well as other indications such as autoimmune diseases, is dependent on effective CAR-T cell manufacturing that impacts not only product safety and efficacy but also overall accessibility to patients in need. In this review, we discuss the major process parameters of autologous CAR-T cell manufacturing, as well as regulatory considerations and ongoing developments that will enable the next generation of CAR-T cell therapies.
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页数:14
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共 156 条
[1]   Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of the phase 3 TRANSFORM study [J].
Abramson, Jeremy S. ;
Solomon, Scott R. ;
Arnason, Jon ;
Johnston, Patrick B. ;
Glass, Bertram ;
Bachanova, Veronika ;
Ibrahimi, Sami ;
Mielke, Stephan ;
Mutsaers, Pim ;
Hernandez-Ilizaliturri, Francisco ;
Izutsu, Koji ;
Morschhauser, Franck ;
Lunning, Matthew ;
Crotta, Alessandro ;
Montheard, Sandrine ;
Previtali, Alessandro ;
Ogasawara, Ken ;
Kamdar, Manali .
BLOOD, 2023, 141 (14) :1675-1684
[2]   Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study [J].
Abramson, Jeremy S. ;
Palomba, M. Lia ;
Gordon, Leo I. ;
Lunning, Matthew A. ;
Wang, Michael ;
Arnason, Jon ;
Mehta, Amitkumar ;
Purev, Enkhtsetseg ;
Maloney, David G. ;
Andreadis, Charalambos ;
Sehgal, Alison ;
Solomon, Scott R. ;
Ghosh, Nilanjan ;
Albertson, Tina M. ;
Garcia, Jacob ;
Kostic, Ana ;
Mallaney, Mary ;
Ogasawara, Ken ;
Newhall, Kathryn ;
Kim, Yeonhee ;
Li, Daniel ;
Siddiqi, Tanya .
LANCET, 2020, 396 (10254) :839-852
[3]   In Vivo Generation of CAR T Cells Selectively in Human CD4+ Lymphocytes [J].
Agarwal, Shiwani ;
Hanauer, Julia D. S. ;
Frank, Annika M. ;
Riechert, Vanessa ;
Thalheimer, Frederic B. ;
Buchholz, Christian J. .
MOLECULAR THERAPY, 2020, 28 (08) :1783-1794
[4]   Clinical outcome of patients with relapsed refractory multiple myeloma listed for BCMA directed commercial CAR-T therapy [J].
Al Hadidi, Samer ;
Szabo, Aniko ;
Esselmann, Jean ;
Hammons, Lindsay ;
Hussain, Munawwar ;
Ogunsesan, Yetunde ;
Thalambedu, Nishanth ;
Khan, Fatima ;
Sethi, Jaskirat ;
Janardan, Abhishek ;
Radhakrishnan, Sabarinath Venniyil ;
Thanendrarajan, Sharmilan ;
Schinke, Carolina ;
Dhakal, Binod ;
Janz, Siegfried ;
Chhabra, Saurabh ;
D'Souza, Anita ;
Zangari, Maurizio ;
van Rhee, Frits ;
Mohan, Meera .
BONE MARROW TRANSPLANTATION, 2023, 58 (04) :443-445
[5]   Functionality and Cell Senescence of CD4/CD8-Selected CD20 CAR T Cells Manufactured Using the Automated CliniMACS Prodigy® Platform [J].
Aleksandrova, Krasimira ;
Leise, Jana ;
Priesner, Christoph ;
Melk, Anette ;
Kubaink, Fanni ;
Abken, Hinrich ;
Hombach, Andreas ;
Aktas, Murat ;
Essl, Mike ;
Buerger, Iris ;
Kaiser, Andrew ;
Rauser, Georg ;
Jurk, Marion ;
Goudeva, Lilia ;
Glienke, Wolfgang ;
Arseniev, Lubomir ;
Esser, Ruth ;
Koehl, Ulrike .
TRANSFUSION MEDICINE AND HEMOTHERAPY, 2019, 46 (01) :47-54
[6]   CAR T cell manufacturing from naive/stem memory T lymphocytes enhances antitumor responses while curtailing cytokine release syndrome [J].
Arcangeli, Silvia ;
Bove, Camilla ;
Mezzanotte, Claudia ;
Camisa, Barbara ;
Falcone, Laura ;
Manfredi, Francesco ;
Bezzecchi, Eugenia ;
El Khoury, Rita ;
Norata, Rossana ;
Sanvito, Francesca ;
Ponzoni, Maurilio ;
Greco, Beatrice ;
Moresco, Marta Angiola ;
Carrabba, Matteo G. ;
Ciceri, Fabio ;
Bonini, Chiara ;
Bondanza, Attilio ;
Casucci, Monica .
JOURNAL OF CLINICAL INVESTIGATION, 2022, 132 (12)
[7]   Next-Generation Manufacturing Protocols Enriching TSCMCAR T Cells Can Overcome Disease-Specific T Cell Defects in Cancer Patients [J].
Arcangeli, Silvia ;
Falcone, Laura ;
Camisa, Barbara ;
De Girardi, Federica ;
Biondi, Marta ;
Giglio, Fabio ;
Ciceri, Fabio ;
Bonini, Chiara ;
Bondanza, Attilio ;
Casucci, Monica .
FRONTIERS IN IMMUNOLOGY, 2020, 11
[8]   Single-cell antigen-specific landscape of CART infusion product identifies determinants of CD19-positive relapse in patients with ALL [J].
Bai, Zhiliang ;
Woodhouse, Steven ;
Zhao, Ziran ;
Arya, Rahul ;
Govek, Kiya ;
Kim, Dongjoo ;
Lundh, Stefan ;
Baysoy, Alev ;
Sun, Hongxing ;
Deng, Yanxiang ;
Xiao, Yang ;
Barrett, David M. ;
Myers, Regina M. ;
Grupp, Stephan A. ;
June, Carl H. ;
Fan, Rong ;
Camara, Pablo G. ;
Melenhorst, J. Joseph .
SCIENCE ADVANCES, 2022, 8 (23)
[9]  
Balke-Want H, 2023, Immunooncol Technol, V18, P100375, DOI 10.1016/j.iotech.2023.100375
[10]   YTB323 (Rapcabtagene Autoleucel) Demonstrates Durable Efficacy and a Manageable Safety Profile in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Phase I Study Update [J].
Barba, Pere ;
Kwon, Mi ;
Briones, Javier ;
Jaeger, Ulrich ;
Bachy, Emmanuel ;
Blaise, Didier ;
Boissel, Nicolas ;
Kato, Koji ;
Shah, Nirav N. ;
Frigault, Matthew ;
Riedell, Peter A. ;
Shune, Leyla O. ;
Teshima, Takanori ;
Ciceri, Fabio ;
Pearson, David ;
Orlando, Elena J. ;
Yi, Lan ;
Davis, Jaclyn ;
Masood, Aisha ;
Flinn, Ian W. ;
Dickinson, Michael .
BLOOD, 2022, 140 :1056-1059