Treatment of CD20-directed Chimeric Antigen Receptor-modified T cells in patients with relapsed or refractory B-cell non-Hodgkin lymphoma:an early phase IIa trial report  

作　　者：Wen-ying Zhang Yao Wang Ye-lei Guo Han-ren Dai Qing-ming Yang Ya-jing Zhang Yan Zhang Mei-xia Chen Chun-meng Wang Kai-chao Feng Su-xia Li Yang Liu Feng-xia Shi Can Luo Wei-dong Han 

机构地区：[1]Biotherapeutic Department,Chinese PLA General Hospital,Beijing,China [2]Department of Immunology,Institute of Basic Medicine,School of Life Sciences,Chinese PLA General Hospital,Beijing,China [3]Department of Geriatric Hematology,Chinese PLA General Hospital,Beijing,China

出　　处：《Signal Transduction and Targeted Therapy》2016年第1期131-139,共9页信号转导与靶向治疗（英文）

基　　金：This study was supported by the grants from the National Natural Science Foundation of China(Nos.31270820,81230061,81121004 and 81402566);was partially supported by a grant from the National Basic Science and Development Programme of China(Nos.2012CB518103,2012AA020502 and 2013BAI01B00).

摘　　要：Patients with relapsed or refractory non-Hodgkin lymphoma have a dismal prognosis.Chimeric Antigen Receptor(CAR)-modified T cells(CART cells)that targeted CD20 were effective in a phase I clinical trial for patients with advanced B-cell lymphomas.We performed a phase IIa trial to further assess the safety and efficacy of administering autologous anti-CD20 CART(CART-20)cells to patients with refractory or relapsed CD20^(+)B-cell lymphoma.Eleven patients were enrolled,and seven patients underwent cytoreductive chemotherapy to debulk the tumors and deplete the lymphocytes before receiving T-cell infusions.The overall objective response rate was 9 of 11(81.8%),with 6 complete remissions(CRs)and 3 partial remissions;no severe toxicity was observed.The median progression-free survival lasted for 46 months,and 1 patient had a 27-month continuous CR.A significant inverse correlation between the levels of the CAR gene and disease recurrence or progression was observed.Clinically,the lesions in special sites,specifically the spleen and testicle,were refractory to CART-20 treatment.Collectively,these results together with our data from phase I strongly demonstrated the feasibility and efficacy of CART-20 treatment in lymphomas and suggest large-scale patient recruitment in a future study.This study was registered at www.clinicaltrials.org as NCT01735604.

关 键 词：PATIENTS LYMPHOMA ANTIGEN 

分 类 号：R73[医药卫生—肿瘤]