Kinetics and biomarkers of severe cytokine release syndrome after CD19 chimeric antigen receptor–modified T-cell therapy

Blood

Volumn 130, Issue 21, 2017, Pages 2295-2306

  Hay, Kevin A ^a,b   Hanafi, Laïla Aïcha ^a   Li, Daniel ^c   Gust, Juliane ^d   Liles, W Conrad ^e   Wurfel, Mark M ^e   López, José A ^e,f   Chen, Junmei ^f   Chung, Dominic ^f   Harju Baker, Susanna ^e   Cherian, Sindhu ^g   Chen, Xueyan ^g   Riddell, Stanley R ^a,e   Maloney, David G ^a,e   Turtle, Cameron J ^a,e  

^a USA   (United States)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c Juno Therapeutics   (United States)

^d SEATTLE CHILDREN S HOSPITAL   (United States)

^e UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^f BloodWorks Northwest   (United States)

^g UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; CD19 ANTIGEN; CHIMERIC ANTIGEN RECEPTOR; CYCLOPHOSPHAMIDE; DEXAMETHASONE; FERRITIN; FLUDARABINE; GAMMA INTERFERON; GROWTH FACTOR; INTERLEUKIN 10; INTERLEUKIN 15; INTERLEUKIN 6; INTERLEUKIN 8; MACROPHAGE INFLAMMATORY PROTEIN 1BETA; MONOCYTE CHEMOTACTIC PROTEIN 1; TOCILIZUMAB; TUMOR NECROSIS FACTOR RECEPTOR; VON WILLEBRAND FACTOR; CD19-SPECIFIC CHIMERIC ANTIGEN RECEPTOR; CYTOKINE; LYMPHOCYTE ANTIGEN RECEPTOR; TUMOR MARKER;

ACUTE KIDNEY FAILURE; ACUTE LYMPHOBLASTIC LEUKEMIA; ADULT; AGED; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ARTICLE; AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION; CANCER CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CAPILLARY LEAK SYNDROME; CELL THERAPY; CHRONIC LYMPHATIC LEUKEMIA; CONTROLLED STUDY; CYTOKINE RELEASE SYNDROME; DISEASE SEVERITY; DISSEMINATED INTRAVASCULAR CLOTTING; FEMALE; GASTROINTESTINAL HEMORRHAGE; HOSPITAL ADMISSION; HUMAN; HYPOALBUMINEMIA; HYPOPROTEINEMIA; HYPOTENSION; INCIDENCE; KARNOFSKY PERFORMANCE STATUS; LIVER DYSFUNCTION; LYMPHODEPLETION CHEMOTHERAPY; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; MEMORY T LYMPHOCYTE; NEUROTOXICITY; NONHODGKIN LYMPHOMA; PARTIAL THROMBOPLASTIN TIME; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTHROMBIN TIME; RISK FACTOR; T LYMPHOCYTE; TACHYCARDIA; TACHYPNEA; THROMBOCYTOPENIA; TUMOR VOLUME; ADOPTIVE IMMUNOTHERAPY; BLOOD CLOTTING DISORDER; CLINICAL TRIAL; COMPLICATION; ENDOTHELIUM CELL; FEVER; HEMATOPOIESIS; HEMODYNAMICS; IMMUNOLOGY; KINETICS; LYMPHOCYTE COUNT; METABOLISM; MIDDLE AGED; MULTIVARIATE ANALYSIS; PATHOLOGY; PATHOPHYSIOLOGY; SYNDROME; TOXICITY AND INTOXICATION; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; AGED; BIOMARKERS, TUMOR; BLOOD COAGULATION DISORDERS; CYTOKINES; ENDOTHELIAL CELLS; FEMALE; FEVER; HEMATOPOIESIS; HEMODYNAMICS; HUMANS; IMMUNOTHERAPY, ADOPTIVE; KINETICS; LYMPHOCYTE COUNT; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; NEUROTOXICITY SYNDROMES; RECEPTORS, ANTIGEN, T-CELL; RISK FACTORS; SYNDROME; T-LYMPHOCYTES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85034805472     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2017-06-793141     Document Type: Article

References (32)

1. Turtle CJ, Hanafi LA, Berger C, et al. Immunotherapy of non-Hodgkin’s lymphoma with a defined ratio of CD81 and CD41 CD19-specific chimeric antigen receptor-modified T cells. Sci Transl Med. 2016;8(355):355ra116.
2. Turtle CJ, Hanafi LA, Berger C, et al. CD19 CART cells of defined CD41:CD81 composition in adult B cell ALL patients. J Clin Invest. 2016; 126(6):2123-2138.
3. Turtle CJ, Hanafi LA, Li D, et al. CD19 CART cells are highly effective in ibrutinib-refractory chronic lymphocytic leukemia [abstract]. Blood. 2016;128(22). Abstract 56.
4. Grupp SA, Kalos M, Barrett D, et al. Chimeric antigen receptor-modified T cells for acute lymphoid leukemia. N Engl J Med. 2013;368(16): 1509-1518.
5. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16): 1507-1517.
6. Lee DW, Kochenderfer JN, Stetler-Stevenson M, et al. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015;385(9967):517-528.
7. Kochenderfer JN, Dudley ME, Kassim SH, et al. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015;33(6):540-549.
8. Porter DL, Hwang WT, Frey NV, et al. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med. 2015;7(303):303ra139.
9. Davila ML, Rivière I, Wang X, et al. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Sci Transl Med. 2014;6(224):224ra25.
10. Locke FL, Neelapu SS, Bartlett NL, et al. Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther. 2017;25(1): 285-295.
11. Hay KA, Turtle CJ. Chimeric Antigen Receptor (CAR) T Cells: Lessons Learned from Targeting of CD19 in B-Cell Malignancies. Drugs. 2017; 77(3):237-245.
12. Gardner RA, Finney O, Annesley C, et al. Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults. Blood. 2017;129(25):3322-3331.
13. Brentjens RJ, Davila ML, Riviere I, et al. CD19-targeted T cells rapidly induce molecular remissions in adults with chemotherapy-refractory acute lymphoblastic leukemia. Sci Transl Med. 2013;5(177):177ra38.
14. Brentjens RJ, Rivière I, Park JH, et al. Safety and persistence of adoptively transferred autologous CD19-targeted T cells in patients with relapsed or chemotherapy refractory B-cell leukemias. Blood. 2011;118(18):4817-4828.
15. Porter DL, Levine BL, Kalos M, Bagg A, June CH. Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia. N Engl J Med. 2011; 365(8):725-733.
16. Fitzgerald JC, Weiss SL, Maude SL, et al. Cytokine release syndrome after chimeric antigen receptor T cell therapy for acute lymphoblastic leukemia. Crit Care Med. 2017;45(2):e124-e131.
17. Brudno JN, Kochenderfer JN. Toxicities of chimeric antigen receptor T cells: recognition and management. Blood. 2016;127(26): 3321-3330.
18. Maude SL, Barrett D, Teachey DT, Grupp SA. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 2014;20(2):119-122.
19. Wang X, Chang WC, Wong CW, et al. A transgene-encoded cell surface polypeptide for selection, in vivo tracking, and ablation of engineered cells. Blood. 2011;118(5): 1255-1263.
20. Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014;124(2): 188-195.
21. Teachey DT, Lacey SF, Shaw PA, et al. Identification of predictive biomarkers for cytokine release syndrome after chimeric antigen receptor T-cell therapy for acute lymphoblastic leukemia. Cancer Discov. 2016;6(6):664-679.
22. Valentijn KM, Sadler JE, Valentijn JA, Voorberg J, Eikenboom J. Functional architecture of Weibel-Palade bodies. Blood. 2011;117(19):5033-5043.
23. Fiedler U, Scharpfenecker M, Koidl S, et al. The Tie-2 ligand angiopoietin-2 is stored in and rapidly released upon stimulation from endothelial cell Weibel-Palade bodies. Blood. 2004;103(11): 4150-4156.
24. Metcalf DJ, Nightingale TD, Zenner HL, Lui-Roberts WW, Cutler DF. Formation and function of Weibel-Palade bodies. J Cell Sci. 2008;121(Pt 1):19-27.
25. Mikacenic C, Hahn WO, Price BL, et al. Biomarkers of endothelial activation are associated with poor outcome in critical illness. PLoS One. 2015;10(10):e0141251.
26. Page AV, Liles WC. Biomarkers of endothelial activation/dysfunction in infectious diseases. Virulence. 2013;4(6):507-516.
27. Page AV, Tarr PI, Watkins SL, et al. Dysregulation of angiopoietin 1 and 2 in Escherichia coli O157: H7 infection and the hemolytic-uremic syndrome. J Infect Dis. 2013;208(6):929-933.
28. Page AV, Kotb M, McGeer A, Low DE, Kain KC, Liles WC. Systemic dysregulation of angiopoietin-1/2 in streptococcal toxic shock syndrome. Clin Infect Dis. 2011;52(8):e157-e161.
29. Ricciuto DR, dos Santos CC, Hawkes M, et al. Angiopoietin-1 and angiopoietin-2 as clinically informative prognostic biomarkers of morbidity and mortality in severe sepsis. Crit Care Med. 2011;39(4):702-710.
30. Lovegrove FE, Tangpukdee N, Opoka RO, et al. Serum angiopoietin-1 and -2 levels discriminate cerebral malaria from uncomplicated malaria and predict clinical outcome in African children. PLoS One. 2009;4(3): e4912-e4918.
31. Darwish I, Liles WC. Emerging therapeutic strategies to prevent infection-related microvascular endothelial activation and dysfunction. Virulence. 2013;4(6):572-582.
32. Ali SA, Shi V, Maric I, et al. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood. 2016;128(13):1688-1700.