Presenter: Prof. Spyridonidis
Participants: Dr Liga, Dr Valera, Dr. Tsokanas
Duration: 20mins

Chimeric antigen receptor (CAR) T cell therapy is rapidly emerging as one of the most promising therapies for hemato-
logic 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 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 Amer-
ican Society for Transplantation and Cellular Therapy (ASTCT; formerly American Society for Blood and Marrow Trans-
plantation, 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 catego-
rize 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