ASTCT关于免疫效应细胞相关细胞因子释放综合征和神经毒性的共识分级
ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells
嵌合抗原受体T细胞（CAR-T）等免疫效应细胞疗法会带来独特的细胞因子释放综合征和神经毒性，但此前各临床试验和机构的分级标准不一，难以比较不同产品的安全性。美国移植与细胞治疗学会（ASTCT）组织多领域专家于2018年6月开会，制定了一套客观、易操作、能更准确反映毒性严重程度的共识定义和分级系统。该共识旨在统一临床试验和上市后临床实践中对这类毒性的评估，方便跨中心比较和管理。这是该领域毒性报告的标准化基础文件。
为什么推荐给您：统一CAR-T毒性分级标准的领域共识，将改变临床研究做法，属方法学规范进展。
不需要生物学背景，多打比方
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摘要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 ofpatients up to age 25years 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 American Society for Transplantation and Cellular Therapy (ASTCT; formerly 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.