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The safety and efficacy of a novel autologous T cell therapy for advanced malignant solid tumors
Received:March 19, 2021  Revised:June 21, 2021  Click here to download the full text
Citation of this paper:LI Wei,LU Li-li,XIAO Shu-xiu,BAI Jin-jin,WANG Zhi-ming,CHENG Li-sha,SONG Zheng-qing,WU Wei-zhong,ZHOU Yu-hong.The safety and efficacy of a novel autologous T cell therapy for advanced malignant solid tumors[J].Chinese Journal of Clinical Medicine,2021,28(5):808-812
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Author NameAffiliationE-mail
LI Wei Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China  
LU Li-li Department of Biotherapeutic Center, Zhongshan Hospital, Fudan University, Shanghai 200032, China  
XIAO Shu-xiu Department of Biotherapeutic Center, Zhongshan Hospital, Fudan University, Shanghai 200032, China  
BAI Jin-jin Department of Biotherapeutic Center, Zhongshan Hospital, Fudan University, Shanghai 200032, China  
WANG Zhi-ming Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China  
CHENG Li-sha Department of Medical Oncology, Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen 361015, Fujian, China  
SONG Zheng-qing Department of Biotherapeutic Center, Zhongshan Hospital, Fudan University, Shanghai 200032, China  
WU Wei-zhong Department of Biotherapeutic Center, Zhongshan Hospital, Fudan University, Shanghai 200032, China  
ZHOU Yu-hong Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China
Department of Biotherapeutic Center, Zhongshan Hospital, Fudan University, Shanghai 200032, China 
zhou.yuhong@zs-hospital.sh.cn 
Abstract:Objective: To explore the efficacy and safety of a novel adoptive T cell therapy induced by PD-1 mAb, IL-2, and IL-15 in treatment with the solid tumors.Methods: A single center, prospective, exploratory phase Ⅰ study was conducted. Patients with advanced solid tumors had undergone a novel T-cell therapy alone or the novel T-cell therapy combined with treatment from March 2018 to December 2020 in Zhongshan Hospital, Fudan University. The primary index was safety, such as the incidence and severity of adverse effects. Secondary index was effectiveness, including quality of life scores and progression free survival. And the change of immune status of patients during treatment was analyzed.Results: Ten patients were enrolled, including 3 patients with hepatocellular carcinoma, 5 with intestinal tumor, 1 with pancreatic cancer, and 1with lung cancer. No treatment-related severe adverse events occurred within 28 days after cell infusion. The qualities of life of all patients were improved after cell therapy, especially in improvement of somatic function, general health, tiredness (P<0.05). Disease progressed in all 3 patients treated with novel T-cell therapy alone. The disease control rate in patients treated with combined therapy was 71.4%. In the nonresponse patients underdoing combined treatment, the percent of Treg in peripheral blood was higher than that in response patients (baseline:P=0.06, 28-days after treatment:P=0.03).Conclusions: Novel autologous T cells generated by PD-1 mAb, IL-2, and IL-15 induction, are safe and manageable and show some anti-tumor effects. The combination of novel autologous T cells and standard therapy has shown good efficacy.
keywords:malignant solid tumor  adoptive cell immuno therapy  programmed cell death-1  T cell
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