Long-term activity of tandem CD19/CD20 CAR therapy in refractory/relapsed B-cell lymphoma: a single-arm, phase 1–2 trial

医学 内科学 胃肠病学 淋巴瘤 细胞因子释放综合征 外科 耐火材料(行星科学) 化疗 存活率 临床研究阶段 嵌合抗原受体 免疫疗法 癌症 物理 天体生物学
作者
Weidong Han,Yao Wang,Yang Liu,Chuan Tong,Chunmeng Wang,Yelei Guo,Dongdong Ti,Qingming Yang,Shen Qiao,Zhiqiang Wu,Weidong Han
出处
期刊:Leukemia [Springer Nature]
卷期号:36 (1): 189-196 被引量:66
标识
DOI:10.1038/s41375-021-01345-8
摘要

Abstract Increasing the remission rate and reducing the recurrence rate can improve the clinical efficacy of chimeric antigen receptor (CAR) T cell therapy in recurrent/refractory non-Hodgkin lymphoma (r/rNHL). In this open-label, single-arm phase I/II trial, 87 patients with r/rNHL, including 58 patients with aggressive diffuse large B-cell lymphoma and 24 with high tumour burden, received an infusion at doses of 0.5 × 10 6 –8 × 10 6 TanCAR7 T cells per kilogram of body weight after conditioning chemotherapy. The best overall response rate was 78% (95% confidence interval [CI], 68–86); response rates were consistent across prognostic subgroups. The median follow-up was 27.7 months. The median progression-free survival was 27.6 months (95% CI, 11 to not reached). Cytokine release syndrome (CRS) occurred in 61 patients (70%) with 60% of cases being grade 1 or 2 and 10% being grade 3 or greater. Grade 3 CAR T cell-related encephalopathy syndrome (CRES) occurred in 2 patients (2%). Two patients died from treatment-associated severe pulmonary infection, and one died from CRS-related pulmonary injury between 1 and 3 months post infusion. Long-term remissions were observed following the use of TanCAR7 T cells in r/rNHL with a safety profile that included CRS but few cases of CRES.
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