不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel:ALYCANTE 最终分析
Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Long-term activity of tandem CD19/CD20 CAR therapy in refractory/relapsed B-cell lymphoma: a single-arm, phase 1-2 trial.
Long-term activity of tandem CD19/CD20 CAR therapy in refractory/relapsed B-cell lymphoma: a single-arm, phase 1-2 trial.
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提高缓解率并降低复发率可改善复发/难治性非霍奇金淋巴瘤(r/r NHL)患者嵌合抗原受体(CAR)T细胞治疗的临床疗效。在这项开放标签、单臂I/II期试验中,87例r/r NHL患者(包括58例侵袭性弥漫大B细胞淋巴瘤患者和24例肿瘤负荷较高者)接受预处理化疗后输注TanCAR7 T细胞,剂量为每千克体重0.5×10^6–8×10^6个。最佳总缓解率为78%(95%置信区间[CI],68–86);各预后亚组的缓解率一致。中位随访时间为27.7个月。中位无进展生存期为27.6个月(95% CI,11个月至尚未达到)。61例患者(70%)发生细胞因子释放综合征(CRS),其中60%为1或2级,10%为3级及以上。2例患者(2%)发生3级CAR-T 细胞相关脑病综合征(CRES)。2例患者死于治疗相关严重肺部感染,另有1例在输注后1至3个月死于CRS相关肺损伤。r/r NHL患者接受TanCAR7 T细胞治疗后可见长期缓解;其安全性特征包括CRS,但CRES病例较少。
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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