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中华移植杂志(电子版) ›› 2022, Vol. 16 ›› Issue (01) : 13 -19. doi: 10.3877/cma.j.issn.1674-3903.2022.01.002

所属专题： 指南共识；

专家共识

嵌合抗原受体T细胞治疗相关血液学不良反应临床管理中国专家共识(2022年版)
中国抗癌协会血液肿瘤专业委员会造血干细胞移植与细胞治疗学组   
  1. 1. 浙江大学医学院附属第一医院骨髓移植中心　良渚实验室　浙江大学血液学研究所　干细胞与细胞免疫治疗浙江省工程研究中心
  • 收稿日期:2022-02-08 出版日期:2022-02-25
  • 基金资助:
    国家自然科学基金重点项目(81730008，82130003); 浙江省重点研发计划(2019C03016，2018C03016-2)

Chinese expert consensus on the clinical management of hematological adverse events associated with chimeric antigen receptor T cell therapy (2022 edition)

Group of Hematopoietic Stem Cell Transplantation and Cellular Therapy, Hematological Oncology Committee of China Anti-Cancer Association   

  • Received:2022-02-08 Published:2022-02-25
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中国抗癌协会血液肿瘤专业委员会造血干细胞移植与细胞治疗学组. 嵌合抗原受体T细胞治疗相关血液学不良反应临床管理中国专家共识(2022年版)[J]. 中华移植杂志(电子版), 2022, 16(01): 13-19.

Group of Hematopoietic Stem Cell Transplantation and Cellular Therapy, Hematological Oncology Committee of China Anti-Cancer Association. Chinese expert consensus on the clinical management of hematological adverse events associated with chimeric antigen receptor T cell therapy (2022 edition)[J]. Chinese Journal of Transplantation(Electronic Edition), 2022, 16(01): 13-19.

表1 美国已上市CAR-T细胞治疗产品的临床特点[53,54,55,56,57,58]
临床特点 YESCARTA®(axicabtagene ciloleucel) # KYMRIAH®(tisagenlecleucel)# BREYANZI®(lisocabtagene maraleucel)# ABECMA®(idecabtagene vicleucel)# TECARTUS®(brexucabtagene autoleucel)# CARVYKTI™(ciltacabtagene autoleucel)
靶抗原位点 CD19 CD19 CD19 BCMA CD19 BCMA
临床适应证 r/r LBCL r/r ALL及LBCL r/r LBCL r/r MM r/r MCL r/r MM
血液学不良反应发生率            
  白细胞减少(≥3级) 96% 77% - 96% 95% -
  中性粒细胞减少(≥3级) 93% 81% 76% 96% 95% -
  淋巴细胞减少(≥3级) 100% 94% - 92% 86% -
  贫血(≥3级) 66% 58% 23% 63% 55% -
  血小板减少(≥3级) 58% 54% 39% 63% 63%  
  APTT延长(≥3级) - - - 10% - -
  ≥3级粒细胞减少延迟恢复* 15% 25% 14% 37% 14% 30%
  ≥3级贫血延迟恢复* 3% - 3% 17% 3% -
  ≥3级血小板减少延迟恢复* 18% 40% 26% 38% 26% 41%
表2 血液学不良反应分级(CTCAE 5.0版)
不良反应 1级 2级 3级 4级 5级
白细胞减少 3.0×109/L~LLN (2.0~3.0)×109/L (1.0~2.0)×109/L <1.0×109/L -
中性粒细胞减少 1.5×109/L~LLN (1.0~1.5)×109/L (0.5~1.0)×109 /L <0.5×109/L -
淋巴细胞减少 0.8×109/L~LLN (0.5~0.8)×109 L (0.2~0.5)×109 /L <0.2×109/L -
贫血 Hb 100 g/L~LLN Hb 80~100 g/L Hb<80 g/L；输血指征 危及生命；紧急干预指征 死亡
血小板减少 75.0×109/L~LLN (50.0~75.0)×109/L (25.0~50.0)×109/L <25.0×109/L -
INR升高 >1.2~1.5 >1.5~2.5 >2.5；出血 - -
APTT延长 >1.0~1.5倍ULN >1.5~2.5倍ULN >2.5倍ULN；出血 - -
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