ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells

Biology of Blood and Marrow Transplantation

Volumn 25, Issue 4, 2019, Pages 625-638

  Lee, Daniel W ^a   Santomasso, Bianca D ^b   Locke, Frederick L ^c   Ghobadi, Armin ^d   Turtle, Cameron J ^e   Brudno, Jennifer N ^f   Maus, Marcela V ^g   Park, Jae H ^b   Mead, Elena ^b   Pavletic, Steven ^f   Go, William Y ^h   Eldjerou, Lamis ⁱ   Gardner, Rebecca A ^j   Frey, Noelle ^k   Curran, Kevin J ^b   Peggs, Karl ^l   Pasquini, Marcelo ^m   DiPersio, John F ^d   van den Brink, Marcel R M ^b   Komanduri, Krishna V ⁿ   Grupp, Stephan A ^k   Neelapu, Sattva S ^o   more..

^a UNIVERSITY OF VIRGINIA   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^d WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e USA   (United States)

^f NATIONAL CANCER INSTITUTE   (United States)

^g MASSACHUSETTS GENERAL HOSPITAL   (United States)

^h Gilead   (United States)

ⁱ NOVARTIS PHARMA AG   (Switzerland)

^j SEATTLE CHILDREN S HOSPITAL   (United States)

^k UNIVERSITY OF PENNSYLVANIA   (United States)

^l UNIVERSITY COLLEGE LONDON   (United Kingdom)

^m MEDICAL COLLEGE OF WISCONSIN   (United States)

ⁿ UNIVERSITY OF MIAMI   (United States)

^o UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

more..

Author keywords

CAR T cell therapy; Cellular immunotherapy; Consensus grading; Cytokine release syndrome; Immune effector cell; Neurotoxicity

Indexed keywords

CELL THERAPY; CLINICAL TRIAL (TOPIC); CYTOKINE RELEASE SYNDROME; DISEASE ASSOCIATION; DISEASE SEVERITY; EFFECTOR CELL; FEVER; HUMAN; HYPOTENSION; HYPOXIA; NEUROTOXICITY; REVIEW; SYMPTOM; CONSENSUS DEVELOPMENT; IMMUNOTHERAPY; PATHOLOGY; PRACTICE GUIDELINE; PROCEDURES;

LYMPHOCYTE ANTIGEN RECEPTOR;

CYTOKINE RELEASE SYNDROME; GUIDELINES AS TOPIC; HUMANS; IMMUNOTHERAPY; RECEPTORS, ANTIGEN, T-CELL;

EID: 85062342961     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2018.12.758     Document Type: Review

References (41)

1. Maude, S.L., Laetsch, T.W., Buechner, J., et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med 378 (2018), 439–448.
2. Neelapu, S.S., Locke, F.L., Bartlett, N.L., et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med 377 (2017), 2531–2544.
3. Locke, F.L., Ghobadi, A., Jacobson, C.A., et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol 20 (2019), 31–42.
4. Schuster, S.J., Bishop, M.R., Tam, C.S., et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med 380 (2019), 45–56.
5. Fry, T.J., Shah, N.N., Orentas, R.J., et al. CD22-targeted CAR T cells induce remission in B-ALL that is naive or resistant to CD19-targeted CAR immunotherapy. Nat Med 24 (2018), 20–28.
6. Ali, S.A., Shi, V., Maric, I., et al. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood 128 (2016), 1688–1700.
7. Suntharalingam, G., Perry, M.R., Ward, S., et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 355 (2006), 1018–1028.
8. Grupp, S.A., Kalos, M., Barrett, D., et al. Chimeric antigen receptor-modified T cells for acute lymphoid leukemia. N Engl J Med 368 (2013), 1509–1518.
9. Rosenbaum, L., Tragedy, perseverance, and chance—the story of CAR-T therapy. N Engl J Med 377 (2017), 1313–1315.
10. National Cancer Institute. Common terminology criteria for adverse events v3.0 (CTCAE). Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed July 20, 2018.
11. National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Version 4.0. Available at: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed July 20, 2018.
12. Neelapu, S.S., Tummala, S., Kebriaei, P., et al. Chimeric antigen receptor T-cell therapy – assessment and management of toxicities. Nat Rev Clin Oncol 15 (2018), 47–62.
13. National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Version 5.0. Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf. Accessed July 20, 2018.
14. Lee, D.W., Gardner, R., Porter, D.L., et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood 124 (2014), 188–195.
15. Davila, M.L., Riviere, 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, 6, 2014 224ra25.
16. Park, J.H., Rivière, I., Gonen, M., et al. Long-term follow-up of CD19 CAR therapy in acute lymphoblastic leukemia. N Engl J Med 378 (2018), 449–459.
17. Porter, D., Frey, N., Wood, P.A., Weng, Y., Grupp, S.A., Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel. J Hematol Oncol, 11, 2018, 35.
18. Norelli, M., Camisa, B., Barbiera, G., et al. Monocyte-derived IL-1 and IL-6 are differentially required for cytokine-release syndrome and neurotoxicity due to CAR T cells. Nat Med 24 (2018), 739–748.
19. Giavridis, T., van der Stegen, S.J.C., Eyquem, J., Hamieh, M., Piersigilli, A., Sadelain, M., CAR T cell-induced cytokine release syndrome is mediated by macrophages and abated by IL-1 blockade. Nat Med 24 (2018), 731–738.
20. Maude, S.L., Frey, N., Shaw, P.A., et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med 371 (2014), 1507–1517.
21. Teachey, D.T., Bishop, M.R., Maloney, D.G., Grupp, S.A., Toxicity management after chimeric antigen receptor T cell therapy: one size does not fit “ALL.”. Nat Rev Clin Oncol, 15, 2018, 218.
22. Teachey, D.T., Lacey, S.F., Shaw, P.A., et al. Identification of predictive biomarkers for cytokine release syndrome after chimeric antigen receptor T-cell therapy for acute lymphoblastic leukemia. Cancer Discov 6 (2016), 664–679.
23. von Stackelberg, A., Locatelli, F., Zugmaier, G., et al. Phase I/Phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia. J Clin Oncol 34 (2016), 4381–4389.
24. Martinelli, G., Boissel, N., Chevallier, P., et al. Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: results from a phase II, single-arm, multicenter study. J Clin Oncol 35 (2017), 1795–1802.
25. Liu, E., Tong, Y., Dotti, G., et al. Cord blood NK cells engineered to express IL-15 and a CD19-targeted CAR show long-term persistence and potent antitumor activity. Leukemia 32 (2018), 520–531.
26. Nellan, A., McCully, C.M.L., Cruz Garcia, R., et al. Improved CNS exposure to tocilizumab after cerebrospinal fluid compared to intravenous administration in rhesus macaques. Blood 132 (2018), 662–666.
27. Porter, D.L., Hwang, W.T., Frey, N.V., et al. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med, 7, 2015 303ra139.
28. Teachey, D.T., Rheingold, S.R., Maude, S.L., et al. Cytokine release syndrome after blinatumomab treatment related to abnormal macrophage activation and ameliorated with cytokine-directed therapy. Blood 121 (2013), 5154–5157.
29. Santomasso, B.D., Park, J.H., Salloum, D., et al. Clinical and biological correlates of neurotoxicity associated with CAR T-cell therapy in patients with B-cell acute lymphoblastic leukemia. Cancer Discov 8 (2018), 958–971.
30. Gust, J., Hay, K.A., Hanafi, L.A., et al. Endothelial activation and blood-brain barrier disruption in neurotoxicity after adoptive immunotherapy with CD19 CAR-T cells. Cancer Discov 7 (2017), 1404–1419.
31. Lee, D.W., Kochenderfer, J.N., 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 385 (2015), 517–528.
32. + composition in adult B cell ALL patients. J Clin Invest 126 (2016), 2123–2138.
33. + CD19-specific chimeric antigen receptor-modified T cells. Sci Transl Med, 8, 2016, 355ra116.
34. Avery, R.A., Shah, S.S., Licht, D.J., et al. Reference range for cerebrospinal fluid opening pressure in children. N Engl J Med 363 (2010), 891–893.
35. Frisén, L., Swelling of the optic nerve head: a staging scheme. J Neurol Neurosurg Psychiatry 45 (1982), 13–18.
36. Traube, C., Silver, G., Kearney, J., et al. Cornell Assessment of Pediatric Delirium: a valid, rapid, observational tool for screening delirium in the PICU. Crit Care Med 42 (2014), 656–663.
37. Silver, G., Kearney, J., Traube, C., Hertzig, M., Delirium screening anchored in child development: the Cornell Assessment for Pediatric Delirium. Palliat Support Care 13 (2015), 1005–1011.
38. Mahadeo, K.M., Khazal, S.J., Abdel-Azim, H., et al. Management guidelines for paediatric patients receiving chimeric antigen receptor T cell therapy. Nat Rev Clin Oncol 16 (2019), 45–63.
39. Center for International Blood and Marrow Transplant Research. Form 4100 R3.0: Cellular Therapy Essential Data Follow-Up Form. Available at: https://www.cibmtr.org/DataManagement/DataCollectionForms/Documents/4100/Rev3.0/4100R3.0.pdf. Accessed November 08, 2018.
40. European Medicines Agency. Report on CAR T-cell therapy registries workshop February 9, 2018: Patient Registries Initiative. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2018/05/WC500249247.pdf. Accessed November 08, 2018.
41. European Medicines Agency. Chimeric antigen receptor (CAR) T-cell therapy registries workshop February 9, 2018. Available at: https://www.ema.europa.eu/en/events/chimeric-antigen-receptor-car-t-cell-therapy-registries-workshop. Accessed January 10, 2018.