Phase I clinical trial of autologous NK cell therapy using novel expansion method in patients with advanced digestive cancer

Journal of Translational Medicine

Volumn 13, Issue 1, 2015, Pages

  Sakamoto, Naoyuki ^a,b   Ishikawa, Takeshi ^a   Kokura, Satoshi ^a,c   Okayama, Tetsuya ^a   Oka, Kaname ^a   Ideno, Mitsuko ^d   Sakai, Fumiyo ^d   Kato, Akiko ^d   Tanabe, Masashige ^d   Enoki, Tatsuji ^d   Mineno, Junichi ^d   Naito, Yuji ^a   Itoh, Yoshito ^a   Yoshikawa, Toshikazu ^a  

^a KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^b Kyoto Prefectural University of Medicine Department of Cancer ImmunoCell Regulation Graduate School of Medical Science ^*  (Japan)

^c Kyoto University of Advanced Science   (Japan)

^d TAKARA BIO INC   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CD16 ANTIGEN; FLUOROURACIL; INTERLEUKIN 2; NATURAL KILLER CELL RECEPTOR NKG2D; PICIBANIL;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BLOOD TOXICITY; CANCER RADIOTHERAPY; CELL ACTIVATION; CELL EXPANSION; CELL POPULATION; CELL THERAPY; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; CONSTIPATION; CYTOTOXICITY; DIARRHEA; EX VIVO STUDY; FATIGUE; FEMALE; FEVER; HUMAN; HUMAN CELL; IN VITRO STUDY; LYMPHOCYTOPENIA; MALE; MIDDLE AGED; MONOTHERAPY; NATURAL KILLER CELL; NAUSEA; NEUTROPENIA; PERIPHERAL BLOOD MONONUCLEAR CELL; PHASE 1 CLINICAL TRIAL; PLEURISY; SAFETY; STOMACH CANCER; T LYMPHOCYTE; THROMBOCYTOPENIA; CLINICAL TRIAL; CYTOLOGY; GASTROINTESTINAL NEOPLASMS; IMMUNOLOGY; IMMUNOPHENOTYPING; IMMUNOTHERAPY;

AGED; FEMALE; GASTROINTESTINAL NEOPLASMS; HUMANS; IMMUNOPHENOTYPING; IMMUNOTHERAPY; KILLER CELLS, NATURAL; MALE; MIDDLE AGED;

EID: 84939815682     PISSN: None     EISSN: 14795876     Source Type: Journal    
DOI: 10.1186/s12967-015-0632-8     Document Type: Article

References (40)

1. Ljunggren HG, Malmberg KJ (2007) Prospects for the use of NK cells in immunotherapy of human cancer. Nat Rev Immunol 7:329-339
2. Vivier E, Raulet DH, Moretta A, Caligiuri MA, Zitvogel L, Lanier LL, Yokoyama WM, Ugolini S (2011) Innate or adaptive immunity? The example of natural killer cells. Science 331:44-49
3. Madjd Z, Spendlove I, Pinder SE, Ellis IO, Durrant LG (2005) Total loss of MHC class I is an independent indicator of good prognosis in breast cancer. Int J Cancer J Int du Cancer 117:248-255
4. Ramnath N, Tan D, Li Q, Hylander BL, Bogner P, Ryes L, Ferrone S (2006) Is downregulation of MHC class I antigen expression in human non-small cell lung cancer associated with prolonged survival? Cancer Immunol Immunother CII 55:891-899
5. Watzl C, Long EO (2000) Exposing tumor cells to killer cell attack. Nat Med 6:867-868
6. Miller JS, Soignier Y, Panoskaltsis-Mortari A, McNearney SA, Yun GH, Fautsch SK, McKenna D, Le C, Defor TE, Burns LJ, Orchard PJ, Blazar BR et al (2005) Successful adoptive transfer and in vivo expansion of human haploidentical NK cells in patients with cancer. Blood 105:3051-3057
7. Rubnitz JE, Inaba H, Ribeiro RC, Pounds S, Rooney B, Bell T, Pui CH, Leung W (2010) NKAML: a pilot study to determine the safety and feasibility of haploidentical natural killer cell transplantation in childhood acute myeloid leukemia. J Clin Oncol Off J Am Soc Clin Oncol 28:955-959
8. Geller MA, Cooley S, Judson PL, Ghebre R, Carson LF, Argenta PA, Jonson AL, Panoskaltsis-Mortari A, Curtsinger J, McKenna D, Dusenbery K, Bliss R et al (2011) A phase II study of allogeneic natural killer cell therapy to treat patients with recurrent ovarian and breast cancer. Cytotherapy 13:98-107
9. Arai S, Meagher R, Swearingen M, Myint H, Rich E, Martinson J, Klingemann H (2008) Infusion of the allogeneic cell line NK-92 in patients with advanced renal cell cancer or melanoma: a phase I trial. Cytotherapy 10:625-632
10. deMagalhaes-Silverman M, Donnenberg A, Lembersky B, Elder E, Lister J, Rybka W, Whiteside T, Ball E (2000) Posttransplant adoptive immunotherapy with activated natural killer cells in patients with metastatic breast cancer. J Immunother 23:154-160
11. Krause SW, Gastpar R, Andreesen R, Gross C, Ullrich H, Thonigs G, Pfister K, Multhoff G (2004) Treatment of colon and lung cancer patients with ex vivo heat shock protein 70-peptide-activated, autologous natural killer cells: a clinical phase I trial. Clin Cancer Res Off J Am Assoc Cancer Res 10:3699-3707
12. Iliopoulou EG, Kountourakis P, Karamouzis MV, Doufexis D, Ardavanis A, Baxevanis CN, Rigatos G, Papamichail M, Perez SA (2010) A phase I trial of adoptive transfer of allogeneic natural killer cells in patients with advanced non-small cell lung cancer. Cancer Immunol Immunother CII 59:1781-1789
13. Ishikawa T, Kokura S, Enoki T, Sakamoto N, Okayama T, Ideno M, Mineno J, Uno K, Yoshida N, Kamada K, Katada K, Uchiyama K et al (2014) Phase I clinical trial of fibronectin CH296-stimulated T cell therapy in patients with advanced cancer. PLoS One 9:e83786
14. Yee C (2010) Adoptive therapy using antigen-specific T-cell clones. Cancer J 16:367-373
15. Naume B, Gately M, Espevik T (1992) A comparative study of IL-12 (cytotoxic lymphocyte maturation factor)-, IL-2-, and IL-7-induced effects on immunomagnetically purified CD56+ NK cells. J Immunol 148:2429-2436
16. Carson WE, Fehniger TA, Haldar S, Eckhert K, Lindemann MJ, Lai CF, Croce CM, Baumann H, Caligiuri MA (1997) A potential role for interleukin-15 in the regulation of human natural killer cell survival. J Clin Investig 99:937-943
17. Perussia B, Ramoni C, Anegon I, Cuturi MC, Faust J, Trinchieri G (1987) Preferential proliferation of natural killer cells among peripheral blood mononuclear cells cocultured with B lymphoblastoid cell lines. Nat Immun Cell Growth Regul 6:171-188
18. McKenna DH Jr, Sumstad D, Bostrom N, Kadidlo DM, Fautsch S, McNearney S, Dewaard R, McGlave PB, Weisdorf DJ, Wagner JE, McCullough J, Miller JS (2007) Good manufacturing practices production of natural killer cells for immunotherapy: a 6-year single-institution experience. Transfusion 47:520-528
19. Koehl U, Brehm C, Huenecke S, Zimmermann SY, Kloess S, Bremm M, Ullrich E, Soerensen J, Quaiser A, Erben S, Wunram C, Gardlowski T et al (2013) Clinical grade purification and expansion of NK cell products for an optimized manufacturing protocol. Front Oncol 3:118
20. Peragine N, Torelli GF, Mariglia P, Pauselli S, Vitale A, Guarini A, Foà R (2015) Immunophenotypic and functional characterization of ex vivo expanded natural killer cells for clinical use in acute lymphoblastic leukemia patients. Cancer Immunol Immunother 64(2):201-211
21. Spanholtz J, Tordoir M, Eissens D, Preijers F, van der Meer A, Joosten I, Schaap N, de Witte TM, Dolstra H (2010) High log-scale expansion of functional human natural killer cells from umbilical cord blood CD34-positive cells for adoptive cancer immunotherapy. PLoS One 5:e9221
22. Ayello J, van de Ven C, Cairo E, Hochberg J, Baxi L, Satwani P, Cairo MS (2009) Characterization of natural killer and natural killer-like T cells derived from ex vivo expanded and activated cord blood mononuclear cells: implications for adoptive cellular immunotherapy. Exp Hematol 37:1216-1229
23. Fujisaki H, Kakuda H, Shimasaki N, Imai C, Ma J, Lockey T, Eldridge P, Leung WH, Campana D (2009) Expansion of highly cytotoxic human natural killer cells for cancer cell therapy. Cancer Res 69:4010-4017
24. Luhm J, Brand JM, Koritke P, Höppner M, Kirchner H, Frohn C (2002) Large-scale generation of natural killer lymphocytes for clinical application. J Hematother Stem Cell Res 11(4):651-657
25. Ideno M, Kato A, Enoki T, Sakamoto N, Ishikawa T, Okayama T, Kokura S, Kitagawa M, Mineno J (2014) A robust and selective expansion method for functional NK cells and its application for in vivo ADCC evaluation system The 5th meeting of Asian Cellular Therapy Organization Osaka, Japan
26. Sutlu T, Alici E (2009) Natural killer cell-based immunotherapy in cancer: current insights and future prospects. J Intern Med 266:154-181
27. Melder RJ, Whiteside TL, Vujanovic NL, Hiserodt JC, Herberman RB (1988) A new approach to generating antitumor effectors for adoptive immunotherapy using human adherent lymphokine-activated killer cells. Cancer Res 48:3461-3469
28. Whiteside TL, Wang YL, Selker RG, Herberman RB (1988) In vitro generation and antitumor activity of adherent lymphokine-activated killer cells from the blood of patients with brain tumors. Cancer Res 48:6069-6075
29. Vujanovic NL, Rabinowich H, Lee YJ, Jost L, Herberman RB, Whiteside TL (1993) Distinct phenotypic and functional characteristics of human natural killer cells obtained by rapid interleukin 2-induced adherence to plastic. Cell Immunol 151:133-157
30. Alici E, Sutlu T, Bjorkstrand B, Gilljam M, Stellan B, Nahi H, Quezada HC, Gahrton G, Ljunggren HG, Dilber MS (2008) Autologous antitumor activity by NK cells expanded from myeloma patients using GMP-compliant components. Blood 111:3155-3162
31. Bazan JF, Bacon KB, Hardiman G, Wang W, Soo K, Rossi D, Greaves DR, Zlotnik A, Schall TJ (1997) A new class of membrane-bound chemokine with a CX3C motif. Nature 385:640-644
32. El-Shazly A, Berger P, Girodet PO, Ousova O, Fayon M, Vernejoux JM, Marthan R, Tunon-de-Lara JM (2006) Fraktalkine produced by airway smooth muscle cells contributes to mast cell recruitment in asthma. J Immunol 176:1860-1868
33. Imai T, Hieshima K, Haskell C, Baba M, Nagira M, Nishimura M, Kakizaki M, Takagi S, Nomiyama H, Schall TJ, Yoshie O (1997) Identification and molecular characterization of fractalkine receptor CX3CR1, which mediates both leukocyte migration and adhesion. Cell 91:521-530
34. Wendel M, Galani IE, Suri-Payer E, Cerwenka A (2008) Natural killer cell accumulation in tumors is dependent on IFN-gamma and CXCR3 ligands. Cancer Res 68:8437-8445
35. Parkhurst MR, Riley JP, Dudley ME, Rosenberg SA (2011) Adoptive transfer of autologous natural killer cells leads to high levels of circulating natural killer cells but does not mediate tumor regression. Clin Cancer Res Off J Am Assoc Cancer Res 17:6287-6297
36. Ruggeri L, Capanni M, Urbani E, Perruccio K, Shlomchik WD, Tosti A, Posati S, Rogaia D, Frassoni F, Aversa F, Martelli MF, Velardi A (2002) Effectiveness of donor natural killer cell alloreactivity in mismatched hematopoietic transplants. Science 295:2097-2100
37. Ruggeri L, Mancusi A, Capanni M, Martelli MF, Velardi A (2005) Exploitation of alloreactive NK cells in adoptive immunotherapy of cancer. Curr Opin Immunol 17:211-217
38. Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon RA, Reed K, Burke MM, Caldwell A et al (2013) Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 369:122-133
39. Kohrt HE, Thielens A, Marabelle A, Sagiv-Barfi I, Sola C, Chanuc F, Fuseri N, Bonnafous C, Czerwinski D, Rajapaksa A, Waller E, Ugolini S et al (2014) Anti-KIR antibody enhancement of anti-lymphoma activity of natural killer cells as monotherapy and in combination with anti-CD20 antibodies. Blood 123:678-686
40. da Silva IP, Gallois A, Jimenez-Baranda S, Khan S, Anderson AC, Kuchroo VK, Osman I, Bhardwaj N (2014) Reversal of NK-cell exhaustion in advanced melanoma by Tim-3 blockade. Cancer Immunol Res 2:410-422