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Volumn 63, Issue 2, 2014, Pages 133-145

Definition and application of good manufacturing process-compliant production of CEA-specific chimeric antigen receptor expressing T-cells for phase I/II clinical trial

Author keywords

Adoptive cell therapy; Bioprocessing; Cell culture; Chimeric antigen receptor; Good manufacturing process; T cell

Indexed keywords

ADOPTIVE TRANSFER; CARCINOEMBRYONIC ANTIGEN; CHIMERIN PROTEINS; HUMANS; IMMUNOPHENOTYPING; INTERFERON-GAMMA; RECEPTORS, ANTIGEN, T-CELL; T-LYMPHOCYTES;

EID: 84894443958     PISSN: 03407004     EISSN: 14320851     Source Type: Journal    
DOI: 10.1007/s00262-013-1492-9     Document Type: Article
Times cited : (25)

References (29)
  • 2
    • 80051775476 scopus 로고    scopus 로고
    • T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia
    • 10.1126/scitranslmed.3002842 1:CAS:528:DC%2BC3MXhtFOisL3N 3393096 21832238
    • Kalos M, Levine BL, Porter DL, Katz S, Grupp SA, Bagg A, June CH (2011) T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia. Sci Transl Med 3(95):95ra73. doi: 10.1126/scitranslmed.3002842
    • (2011) Sci Transl Med , vol.3 , Issue.95
    • Kalos, M.1    Levine, B.L.2    Porter, D.L.3    Katz, S.4    Grupp, S.A.5    Bagg, A.6    June, C.H.7
  • 4
    • 80051720194 scopus 로고    scopus 로고
    • Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia
    • 10.1056/NEJMoa1103849 1:CAS:528:DC%2BC3MXhtV2lu7nP 3387277 21830940 10.1056/NEJMoa1103849
    • Porter DL, Levine BL, Kalos M, Bagg A, June CH (2011) Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia. N Engl J Med 365(8):725-733. doi: 10.1056/NEJMoa1103849
    • (2011) N Engl J Med , vol.365 , Issue.8 , pp. 725-733
    • Porter, D.L.1    Levine, B.L.2    Kalos, M.3    Bagg, A.4    June, C.H.5
  • 5
    • 84863085396 scopus 로고    scopus 로고
    • CAR-T cells and solid tumors: Tuning T cells to challenge an inveterate foe
    • 10.1016/j.molmed.2012.04.009 1:CAS:528:DC%2BC38XhtVShsb7F 22613370 10.1016/j.molmed.2012.04.009
    • Gilham DE, Debets R, Pule M, Hawkins RE, Abken H (2012) CAR-T cells and solid tumors: tuning T cells to challenge an inveterate foe. Trends Mol Med 18(7):377-384. doi: 10.1016/j.molmed.2012.04.009
    • (2012) Trends Mol Med , vol.18 , Issue.7 , pp. 377-384
    • Gilham, D.E.1    Debets, R.2    Pule, M.3    Hawkins, R.E.4    Abken, H.5
  • 6
    • 84862775412 scopus 로고    scopus 로고
    • Targeted immunotherapy of cancer with CAR T cells: Achievements and challenges
    • 10.1007/s00262-012-1254-0 1:CAS:528:DC%2BC38XptVGms7g%3D 22527245 10.1007/s00262-012-1254-0
    • Lipowska-Bhalla G, Gilham DE, Hawkins RE, Rothwell DG (2012) Targeted immunotherapy of cancer with CAR T cells: achievements and challenges. Cancer Immunol Immunother 61(7):953-962. doi: 10.1007/s00262-012-1254-0
    • (2012) Cancer Immunol Immunother , vol.61 , Issue.7 , pp. 953-962
    • Lipowska-Bhalla, G.1    Gilham, D.E.2    Hawkins, R.E.3    Rothwell, D.G.4
  • 8
    • 0028989908 scopus 로고
    • A single chain Fv derived from a filamentous phage library has distinct tumor targeting advantages over one derived from a hybridoma
    • 10.1002/ijc.2910610412 1:CAS:528:DyaK2MXmsVGksbk%3D 7759155 10.1002/ijc.2910610412
    • Verhaar MJ, Chester KA, Keep PA, Robson L, Pedley RB, Boden JA, Hawkins RE, Begent RH (1995) A single chain Fv derived from a filamentous phage library has distinct tumor targeting advantages over one derived from a hybridoma. Int J Cancer 61(4):497-501. doi: 10.1002/ijc.2910610412
    • (1995) Int J Cancer , vol.61 , Issue.4 , pp. 497-501
    • Verhaar, M.J.1    Chester, K.A.2    Keep, P.A.3    Robson, L.4    Pedley, R.B.5    Boden, J.A.6    Hawkins, R.E.7    Begent, R.H.8
  • 10
    • 33751259946 scopus 로고    scopus 로고
    • A phase i study of single administration of antibody-directed enzyme prodrug therapy with the recombinant anti-carcinoembryonic antigen antibody-enzyme fusion protein MFECP1 and a bis-iodo phenol mustard prodrug
    • 10.1158/1078-0432.CCR-06-0769 1:CAS:528:DC%2BD28XhtFKitbrF 17085666 10.1158/1078-0432.CCR-06-0769
    • Mayer A, Francis RJ, Sharma SK, Tolner B, Springer CJ, Martin J, Boxer GM, Bell J, Green AJ, Hartley JA, Cruickshank C, Wren J, Chester KA, Begent RH (2006) A phase I study of single administration of antibody-directed enzyme prodrug therapy with the recombinant anti-carcinoembryonic antigen antibody-enzyme fusion protein MFECP1 and a bis-iodo phenol mustard prodrug. Clin Cancer Res 12(21):6509-6516. doi: 10.1158/1078-0432.CCR-06-0769
    • (2006) Clin Cancer Res , vol.12 , Issue.21 , pp. 6509-6516
    • Mayer, A.1    Francis, R.J.2    Sharma, S.K.3    Tolner, B.4    Springer, C.J.5    Martin, J.6    Boxer, G.M.7    Bell, J.8    Green, A.J.9    Hartley, J.A.10    Cruickshank, C.11    Wren, J.12    Chester, K.A.13    Begent, R.H.14
  • 11
    • 0036193484 scopus 로고    scopus 로고
    • Primary polyclonal human T lymphocytes targeted to carcino-embryonic antigens and neural cell adhesion molecule tumor antigens by CD3zeta-based chimeric immune receptors
    • 10.1097/00002371-200203000-00002 1:CAS:528:DC%2BD38XjtFSnu7g%3D 12074044 10.1097/00002371-200203000-00002
    • Gilham DE, O'Neil A, Hughes C, Guest RD, Kirillova N, Lehane M, Hawkins RE (2002) Primary polyclonal human T lymphocytes targeted to carcino-embryonic antigens and neural cell adhesion molecule tumor antigens by CD3zeta-based chimeric immune receptors. J Immunother 25(2):139-151. doi: 10.1097/00002371- 200203000-00002
    • (2002) J Immunother , vol.25 , Issue.2 , pp. 139-151
    • Gilham, D.E.1    O'Neil, A.2    Hughes, C.3    Guest, R.D.4    Kirillova, N.5    Lehane, M.6    Hawkins, R.E.7
  • 12
    • 0038185191 scopus 로고    scopus 로고
    • T lymphocytes isolated from patients with advanced colorectal cancer are suitable for gene immunotherapy approaches
    • 10.1038/sj.bjc.6600857 1:CAS:528:DC%2BD3sXisFahtL4%3D 2376387 12671714 10.1038/sj.bjc.6600857
    • Sheen AJ, Sherlock DJ, Irlam J, Hawkins RE, Gilham DE (2003) T lymphocytes isolated from patients with advanced colorectal cancer are suitable for gene immunotherapy approaches. Br J Cancer 88(7):1119-1127. doi: 10.1038/sj.bjc.6600857
    • (2003) Br J Cancer , vol.88 , Issue.7 , pp. 1119-1127
    • Sheen, A.J.1    Sherlock, D.J.2    Irlam, J.3    Hawkins, R.E.4    Gilham, D.E.5
  • 13
    • 33947633597 scopus 로고    scopus 로고
    • T cell activation by antibody-like immunoreceptors: The position of the binding epitope within the target molecule determines the efficiency of activation of redirected T cells
    • 1:CAS:528:DC%2BD2sXjt1WksLY%3D 17372024
    • Hombach AA, Schildgen V, Heuser C, Finnern R, Gilham DE, Abken H (2007) T cell activation by antibody-like immunoreceptors: the position of the binding epitope within the target molecule determines the efficiency of activation of redirected T cells. J Immunol 178(7):4650-4657
    • (2007) J Immunol , vol.178 , Issue.7 , pp. 4650-4657
    • Hombach, A.A.1    Schildgen, V.2    Heuser, C.3    Finnern, R.4    Gilham, D.E.5    Abken, H.6
  • 14
    • 20944439742 scopus 로고    scopus 로고
    • The role of extracellular spacer regions in the optimal design of chimeric immune receptors: Evaluation of four different scFvs and antigens
    • 10.1097/01.cji.0000161397.96582.59 1:CAS:528:DC%2BD2MXjtlKlurc%3D 15838376 10.1097/01.cji.0000161397.96582.59
    • Guest RD, Hawkins RE, Kirillova N, Cheadle EJ, Arnold J, O'Neill A, Irlam J, Chester KA, Kemshead JT, Shaw DM, Embleton MJ, Stern PL, Gilham DE (2005) The role of extracellular spacer regions in the optimal design of chimeric immune receptors: evaluation of four different scFvs and antigens. J Immunother 28(3):203-211. doi: 10.1097/01.cji.0000161397.96582.59
    • (2005) J Immunother , vol.28 , Issue.3 , pp. 203-211
    • Guest, R.D.1    Hawkins, R.E.2    Kirillova, N.3    Cheadle, E.J.4    Arnold, J.5    O'Neill, A.6    Irlam, J.7    Chester, K.A.8    Kemshead, J.T.9    Shaw, D.M.10    Embleton, M.J.11    Stern, P.L.12    Gilham, D.E.13
  • 15
    • 84861178107 scopus 로고    scopus 로고
    • Clinical evaluation of TRICOM vector therapeutic cancer vaccines
    • 10.1053/j.seminoncol.2012.02.010 1:CAS:528:DC%2BC38Xnt12kt7w%3D 3398615 22595052 10.1053/j.seminoncol.2012.02.010
    • Madan RA, Bilusic M, Heery C, Schlom J, Gulley JL (2012) Clinical evaluation of TRICOM vector therapeutic cancer vaccines. Semin Oncol 39(3):296-304. doi: 10.1053/j.seminoncol.2012.02.010
    • (2012) Semin Oncol , vol.39 , Issue.3 , pp. 296-304
    • Madan, R.A.1    Bilusic, M.2    Heery, C.3    Schlom, J.4    Gulley, J.L.5
  • 16
    • 0033835705 scopus 로고    scopus 로고
    • Interleukin 2 maintains biologic stability and sterility over prolonged time
    • 10.1016/S0162-3109(00)00241-1 1:CAS:528:DC%2BD3cXmtlGlur0%3D 10996039 10.1016/S0162-3109(00)00241-1
    • Safar M, Junghans RP (2000) Interleukin 2 maintains biologic stability and sterility over prolonged time. Immunopharmacology 49(3):419-423. doi: 10.1016/S0162-3109(00)00241-1
    • (2000) Immunopharmacology , vol.49 , Issue.3 , pp. 419-423
    • Safar, M.1    Junghans, R.P.2
  • 17
    • 0037737468 scopus 로고    scopus 로고
    • Preclinical evaluation of an automated closed fluid management device: Cytomate, for washing out DMSO from hematopoietic stem cell grafts after thawing
    • 10.1038/sj.bmt.1703905 1:STN:280:DC%2BD3s3htFajsA%3D%3D 12732892 10.1038/sj.bmt.1703905
    • Calmels B, Houze P, Hengesse JC, Ducrot T, Malenfant C, Chabannon C (2003) Preclinical evaluation of an automated closed fluid management device: Cytomate, for washing out DMSO from hematopoietic stem cell grafts after thawing. Bone Marrow Transplant 31(9):823-828. doi: 10.1038/sj.bmt.1703905
    • (2003) Bone Marrow Transplant , vol.31 , Issue.9 , pp. 823-828
    • Calmels, B.1    Houze, P.2    Hengesse, J.C.3    Ducrot, T.4    Malenfant, C.5    Chabannon, C.6
  • 19
    • 47249164767 scopus 로고    scopus 로고
    • Retronectin-assisted retroviral transduction of primary human T lymphocytes under good manufacturing practice conditions: Tissue culture bag critically determines cell yield
    • 10.1080/14653240801982961 1:CAS:528:DC%2BD1cXns1Sls7s%3D 18574773 10.1080/14653240801982961
    • Lamers CH, van Elzakker P, van Steenbergen SC, Sleijfer S, Debets R, Gratama JW (2008) Retronectin-assisted retroviral transduction of primary human T lymphocytes under good manufacturing practice conditions: tissue culture bag critically determines cell yield. Cytotherapy 10(4):406-416. doi: 10.1080/14653240801982961
    • (2008) Cytotherapy , vol.10 , Issue.4 , pp. 406-416
    • Lamers, C.H.1    Van Elzakker, P.2    Van Steenbergen, S.C.3    Sleijfer, S.4    Debets, R.5    Gratama, J.W.6
  • 20
    • 0036019378 scopus 로고    scopus 로고
    • Protocol for gene transduction and expansion of human T lymphocytes for clinical immunogene therapy of cancer
    • 10.1038/sj.cgt.7700477 1:CAS:528:DC%2BD38XkslKmsb4%3D 12082462 10.1038/sj.cgt.7700477
    • Lamers CH, Willemsen RA, Luider BA, Debets R, Bolhuis RL (2002) Protocol for gene transduction and expansion of human T lymphocytes for clinical immunogene therapy of cancer. Cancer Gene Ther 9(7):613-623. doi: 10.1038/sj.cgt.7700477
    • (2002) Cancer Gene Ther , vol.9 , Issue.7 , pp. 613-623
    • Lamers, C.H.1    Willemsen, R.A.2    Luider, B.A.3    Debets, R.4    Bolhuis, R.L.5
  • 22
    • 84878605813 scopus 로고    scopus 로고
    • Treatment of metastatic renal cell carcinoma with CAIX CAR-engineered T cells: Clinical evaluation and management of on-target toxicity
    • 10.1038/mt.2013.17 1:CAS:528:DC%2BC3sXislWhtbw%3D 23423337 10.1038/mt.2013.17
    • Lamers CH, Sleijfer S, van Steenbergen S, van Elzakker P, van Krimpen B, Groot C, Vulto A, den Bakker M, Oosterwijk E, Debets R, Gratama JW (2013) Treatment of metastatic renal cell carcinoma with CAIX CAR-engineered T cells: clinical evaluation and management of on-target toxicity. Mol Ther 21(4):904-912. doi: 10.1038/mt.2013.17
    • (2013) Mol Ther , vol.21 , Issue.4 , pp. 904-912
    • Lamers, C.H.1    Sleijfer, S.2    Van Steenbergen, S.3    Van Elzakker, P.4    Van Krimpen, B.5    Groot, C.6    Vulto, A.7    Den Bakker, M.8    Oosterwijk, E.9    Debets, R.10    Gratama, J.W.11
  • 23
    • 77950475517 scopus 로고    scopus 로고
    • Case report of a serious adverse event following the administration of T cells transduced with a chimeric antigen receptor recognizing ERBB2
    • 10.1038/mt.2010.24 1:CAS:528:DC%2BC3cXitlaitb4%3D 20179677 10.1038/mt.2010.24
    • Morgan RA, Yang JC, Kitano M, Dudley ME, Laurencot CM, Rosenberg SA (2010) Case report of a serious adverse event following the administration of T cells transduced with a chimeric antigen receptor recognizing ERBB2. Mol Ther 18(4):843-851. doi: 10.1038/mt.2010.24
    • (2010) Mol Ther , vol.18 , Issue.4 , pp. 843-851
    • Morgan, R.A.1    Yang, J.C.2    Kitano, M.3    Dudley, M.E.4    Laurencot, C.M.5    Rosenberg, S.A.6
  • 24
    • 33845298659 scopus 로고    scopus 로고
    • Process validation and clinical evaluation of a protocol to generate gene-modified T lymphocytes for imunogene therapy for metastatic renal cell carcinoma: GMP-controlled transduction and expansion of patient's T lymphocytes using a carboxy anhydrase IX-specific scFv transgene
    • 10.1080/14653240601056396 1:CAS:528:DC%2BD2sXit1aqtbY%3D 17148030 10.1080/14653240601056396
    • Lamers CH, van Elzakker P, Langeveld SC, Sleijfer S, Gratama JW (2006) Process validation and clinical evaluation of a protocol to generate gene-modified T lymphocytes for imunogene therapy for metastatic renal cell carcinoma: GMP-controlled transduction and expansion of patient's T lymphocytes using a carboxy anhydrase IX-specific scFv transgene. Cytotherapy 8(6):542-553. doi: 10.1080/14653240601056396
    • (2006) Cytotherapy , vol.8 , Issue.6 , pp. 542-553
    • Lamers, C.H.1    Van Elzakker, P.2    Langeveld, S.C.3    Sleijfer, S.4    Gratama, J.W.5
  • 25
    • 84866735170 scopus 로고    scopus 로고
    • Paths to stemness: Building the ultimate antitumour T cell
    • 10.1038/nrc3322 1:CAS:528:DC%2BC38XhtlyltLfI 22996603 10.1038/nrc3322
    • Gattinoni L, Klebanoff CA, Restifo NP (2012) Paths to stemness: building the ultimate antitumour T cell. Nat Rev Cancer 12(10):671-684. doi: 10.1038/nrc3322
    • (2012) Nat Rev Cancer , vol.12 , Issue.10 , pp. 671-684
    • Gattinoni, L.1    Klebanoff, C.A.2    Restifo, N.P.3
  • 27
    • 84877836562 scopus 로고    scopus 로고
    • Modulating the differentiation status of ex vivo-cultured anti-tumor T cells using cytokine cocktails
    • 10.1007/s00262-012-1378-2 1:CAS:528:DC%2BC3sXmt1eqt7w%3D 23207483 10.1007/s00262-012-1378-2
    • Yang S, Ji Y, Gattinoni L, Zhang L, Yu Z, Restifo NP, Rosenberg SA, Morgan RA (2013) Modulating the differentiation status of ex vivo-cultured anti-tumor T cells using cytokine cocktails. Cancer Immunol Immunother 62(4):727-736. doi: 10.1007/s00262-012-1378-2
    • (2013) Cancer Immunol Immunother , vol.62 , Issue.4 , pp. 727-736
    • Yang, S.1    Ji, Y.2    Gattinoni, L.3    Zhang, L.4    Yu, Z.5    Restifo, N.P.6    Rosenberg, S.A.7    Morgan, R.A.8
  • 28
    • 84859179612 scopus 로고    scopus 로고
    • Clinical scale rapid expansion of lymphocytes for adoptive cell transfer therapy in the WAVE(R) bioreactor
    • 10.1186/1479-5876-10-69 3402993 22475724 10.1186/1479-5876-10-69
    • Somerville RP, Devillier L, Parkhurst MR, Rosenberg SA, Dudley ME (2012) Clinical scale rapid expansion of lymphocytes for adoptive cell transfer therapy in the WAVE(R) bioreactor. J Transl Med 10:69. doi: 10.1186/1479-5876-10-69
    • (2012) J Transl Med , vol.10 , pp. 69
    • Somerville, R.P.1    Devillier, L.2    Parkhurst, M.R.3    Rosenberg, S.A.4    Dudley, M.E.5
  • 29
    • 76949100884 scopus 로고    scopus 로고
    • Accelerated production of antigen-specific T cells for preclinical and clinical applications using gas-permeable rapid expansion cultureware (G-Rex)
    • 10.1097/CJI.0b013e3181c0c3cb 1:CAS:528:DC%2BC3cXltFGnsrw%3D 2946348 20445351 10.1097/CJI.0b013e3181c0c3cb
    • Vera JF, Brenner LJ, Gerdemann U, Ngo MC, Sili U, Liu H, Wilson J, Dotti G, Heslop HE, Leen AM, Rooney CM (2010) Accelerated production of antigen-specific T cells for preclinical and clinical applications using gas-permeable rapid expansion cultureware (G-Rex). J Immunother 33(3):305-315. doi: 10.1097/CJI.0b013e3181c0c3cb
    • (2010) J Immunother , vol.33 , Issue.3 , pp. 305-315
    • Vera, J.F.1    Brenner, L.J.2    Gerdemann, U.3    Ngo, M.C.4    Sili, U.5    Liu, H.6    Wilson, J.7    Dotti, G.8    Heslop, H.E.9    Leen, A.M.10    Rooney, C.M.11


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