• Mol. Ther. · May 2017

    Phase I Escalating-Dose Trial of CAR-T Therapy Targeting CEA+ Metastatic Colorectal Cancers.

    • Chengcheng Zhang, Zhe Wang, Zhi Yang, Meiling Wang, Shiqi Li, Yunyan Li, Rui Zhang, Zhouxing Xiong, Zhihao Wei, Junjie Shen, Yongli Luo, Qianzhen Zhang, Limei Liu, Hong Qin, Wei Liu, Feng Wu, Wei Chen, Feng Pan, Xianquan Zhang, Ping Bie, Houjie Liang, Gabriele Pecher, and Cheng Qian.
    • Center of Biotherapy, Southwest Hospital, Third Military Medical University, Chongqing 400038, China; Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing 400038, China.
    • Mol. Ther. 2017 May 3; 25 (5): 1248-1258.

    AbstractChimeric antigen receptor T (CAR-T) cells have shown promising efficacy in treatment of hematological malignancies, but its applications in solid tumors need further exploration. In this study, we investigated CAR-T therapy targeting carcino-embryonic antigen (CEA)-positive colorectal cancer (CRC) patients with metastases to evaluate its safety and efficacy. Five escalating dose levels (DLs) (1 × 105 to 1 × 108/CAR+/kg cells) of CAR-T were applied in 10 CRC patients. Our data showed that severe adverse events related to CAR-T therapy were not observed. Of the 10 patients, 7 patients who experienced progressive disease (PD) in previous treatments had stable disease after CAR-T therapy. Two patients remained with stable disease for more than 30 weeks, and two patients showed tumor shrinkage by positron emission tomography (PET)/computed tomography (CT) and MRI analysis, respectively. Decline of serum CEA level was apparent in most patients even in long-term observation. Furthermore, we observed persistence of CAR-T cells in peripheral blood of patients receiving high doses of CAR-T therapy. Importantly, we observed CAR-T cell proliferation especially in patients after a second CAR-T therapy. Taken together, we demonstrated that CEA CAR-T cell therapy was well tolerated in CEA+ CRC patients even in high doses, and some efficacy was observed in most of the treated patients.Copyright © 2017 The American Society of Gene and Cell Therapy. Published by Elsevier Inc. All rights reserved.

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