CAR-T（CAR-T）细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
relmacabtagene autoleucel 治疗中国复发/难治性大 B 细胞淋巴瘤患者的长期结局：RELIANCE 研究更新结果
英文原题：Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study.
查看英文原题
Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study.
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研究概要
RELIANCE 研究的更新数据显示，relma-cel 在经过重度预处理的复发/难治性 LBCL 患者中具有持久缓解和可控的安全性。
中文摘要
背景与目的
RELIANCE研究已证实CD19靶向CAR-T 细胞产品relmacabtagene autoleucel（relma-cel；中国上海药明巨诺生物科技有限公司）对既往接受多线治疗的复发/难治性大B细胞淋巴瘤（r/r LBCL）患者具有活性且安全。本研究报告RELIANCE研究更新后的2年数据。
方法
RELIANCE研究（NCT04089215）是一项在中国10个临床中心开展的开放标签、多中心、随机、注册性I/II期临床试验。既往接受多线治疗的成人r/r LBCL患者入组后接受淋巴细胞清除化疗，随后输注1×10⁸或1.5×10⁸个relma-cel。主要终点为研究者评估的3个月客观缓解率（ORR）；次要终点包括缓解持续时间（DoR）、无进展生存期（PFS）、总生存期（OS）和安全性特征。
结果
2017年11月至2022年1月，共入组68例患者，其中59例接受relma-cel输注。截至2022年3月29日，59例患者的中位随访时间为17.9个月（范围0.3–25.6个月）。ORR为77.59%（95%置信区间［CI］64.73–87.49），完全缓解率为53.45%（95% CI 39.87–66.66）。DoR中位数为20.3个月（95% CI 4.86个月至未达到），PFS中位数为7.0个月（95% CI 4.76–24.15）。OS中位数尚未达到，1年和2年OS率分别为75.0%和69.3%。3例（5.1%）患者发生3级细胞因子释放综合征，2例（3.4%）发生3级神经毒性。
结论
RELIANCE研究更新数据表明，relma-cel可使既往接受多线治疗的r/r LBCL患者获得持久缓解，且安全性可管理。
展开英文摘要原文
METHODS
The RELIANCE study (NCT04089215) was an open-label, multi-center, randomized, phase 1/2 registrational clinical trial conducted at 10 clinical sites in China. Adult patients with heavily pre-treated r/r LBCL were enrolled and received lymphodepletion chemotherapy followed by infusion of 100 10 6 or 150 10 6 relma-cel. The primary endpoint was objective response rate (ORR) at 3 months, as assessed by investigators. Secondary endpoints were duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety profiles.
RESULTS
From November 2017 to January 2022, a total of 68 patients were enrolled, and 59 patients received relma-cel infusion. As of March 29, 2022, a total of 59 patients had a median follow-up of 17.9 months (range, 0.3-25.6). ORR was 77.59% (95% confidence interval [CI], 64.73-87.49) and complete response rate was 53.45% (95% CI, 39.87-66.66). Median DoR was 20.3 months (95% CI, 4.86-not reached [NR]) and median PFS was 7.0 months (95% CI, 4.76-24.15). Median OS was NR and 1-year and 2-year OS rates were 75.0% and 69.3%, respectively. Three (5.1%) patients experienced grade 3 cytokine release syndrome and two (3.4%) patients had grade 3 neurotoxicity.
CONCLUSIONS
The updated data of the RELIANCE study demonstrate durable response with and manageable safety profile of relma-cel in patients with heavily pre-treated r/r LBCL.
论文信息
- 作者
- Ying Z、Yang H、Guo Y、Li W、Zou D、Zhou D、Wang Z、Zhang M
- 第一作者单位
- Department of Lymphoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China.China
- 通讯作者单位
- Department of Lymphoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China. Electronic address: zhu-jun2017@outlook.com.China
- 文献类型
- I 期临床试验 · II 期临床试验 · 多中心研究 · 随机对照试验 · 非美国政府资助研究
- 期刊
- Cytotherapy2023 May
- 原文标识
- PubMed 36842849 · DOI 10.1016/j.jcyt.2022.10.011