Lee, DW; Santomasso, BD; Locke, FL; Ghobadi, A; Turtle, CJ; Brudno, JN; Maus, MV; ... Neelapu, SS; + view all Lee, DW; Santomasso, BD; Locke, FL; Ghobadi, A; Turtle, CJ; Brudno, JN; Maus, MV; Park, JH; Mead, E; Pavletic, S; Go, WY; Eldjerou, L; Gardner, RA; Frey, N; Curran, KJ; Peggs, K; Pasquini, M; DiPersio, JF; van den Brink, MRM; Komanduri, KV; Grupp, SA; Neelapu, SS; - view fewer (2018) ASBMT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biology of Blood and Marrow Transplantation 10.1016/j.bbmt.2018.12.758. (In press).

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Abstract

Chimeric antigen receptor (CAR) T cell therapy is rapidly emerging as one of the most promising therapies for hematologic malignancies. Two CAR T products were recently approved in the United States and Europe for the treatment of patients up to age 25 years with relapsed or refractory B cell acute lymphoblastic leukemia years "?>and/or adults with large B cell lymphoma. Many more CAR T products, as well as other immunotherapies, including various immune cell- and bi-specific antibody-based approaches that function by activation of immune effector cells, are in clinical development for both hematologic and solid tumor malignancies. These therapies are associated with unique toxicities of cytokine release syndrome (CRS) and neurologic toxicity. The assessment and grading of these toxicities vary considerably across clinical trials and across institutions, making it difficult to compare the safety of different products and hindering the ability to develop optimal strategies for management of these toxicities. Moreover, some aspects of these grading systems can be challenging to implement across centers. Therefore, in an effort to harmonize the definitions and grading systems for CRS and neurotoxicity, experts from all aspects of the field met on June 20 and 21, 2018, at a meeting supported by the American Society for Blood and Marrow Transplantation (ASBMT) in Arlington, VA. Here we report the consensus recommendations of that group and propose new definitions and grading for CRS and neurotoxicity that are objective, easy to apply, and ultimately more accurately categorize the severity of these toxicities. The goal is to provide a uniform consensus grading system for CRS and neurotoxicity associated with immune effector cell therapies, for use across clinical trials and in the postapproval clinical setting.

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