Influence of patient characteristics on chimeric antigen receptor T cell therapy in B-cell acute lymphoblastic leukemia

Furun An, Huiping Wang, Zhenyun Liu, Fan Wu, Jiakui Zhang, Qianshan Tao, Yingwei Li, Yuanyuan Shen, Yanjie Ruan, Qing Zhang, Ying Pan, Weiwei Zhu, Hui Qin, Yansheng Wang, Yongling Fu, Zhenqing Feng () and Zhimin Zhai ()
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Furun An: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Huiping Wang: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Zhenyun Liu: Hematologic Diseases Research Center of Anhui Medical University
Fan Wu: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Jiakui Zhang: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Qianshan Tao: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Yingwei Li: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Yuanyuan Shen: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Yanjie Ruan: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Qing Zhang: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Ying Pan: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Weiwei Zhu: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Hui Qin: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Yansheng Wang: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)
Yongling Fu: Sinobioway Cell Therapy Co., Ltd.
Zhenqing Feng: Key Laboratory of Antibody Technique of National Health Commission, Nanjing Medical University
Zhimin Zhai: Hematology Department, the Second Hospital of Anhui Medical University (SHAMU)

Nature Communications, 2020, vol. 11, issue 1, 1-11

Abstract: Abstract CD19-specific chimeric antigen receptor T cell (CD19 CAR T) therapy has shown high remission rates in patients with refractory/relapsed B-cell acute lymphoblastic leukemia (r/r B-ALL). However, the long-term outcome and the factors that influence the efficacy need further exploration. Here we report the outcome of 51 r/r B-ALL patients from a non-randomized, Phase II clinical trial (ClinicalTrials.gov number: NCT02735291). The primary outcome shows that the overall remission rate (complete remission with or without incomplete hematologic recovery) is 80.9%. The secondary outcome reveals that the overall survival (OS) and relapse-free survival (RFS) rates at 1 year are 53.0 and 45.0%, respectively. The incidence of grade 4 adverse reactions is 6.4%. The trial meets pre-specified endpoints. Further analysis shows that patients with extramedullary diseases (EMDs) other than central nervous system (CNS) involvement have the lowest remission rate (28.6%). The OS and RFS in patients with any subtype of EMDs, higher Tregs, or high-risk genetic factors are all significantly lower than that in their corresponding control cohorts. EMDs and higher Tregs are independent high-risk factors respectively for poor OS and RFS. Thus, these patient characteristics may hinder the efficacy of CAR T therapy.

Date: 2020
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DOI: 10.1038/s41467-020-19774-x

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