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阿基仑赛(axi-cel)与瑞基奥仑赛(relma-cel)在中国人群复发/难治性大 B 细胞淋巴瘤中的临床结局与免疫表型:单中心经验

英文原题:Clinical outcome and immunophenotype of axicabtagene ciloleucel (axi-cel) and relmacabtagene autoleucel (relma-cel) in relapsed/refractory large B-Cell lymphoma on Chinese population: a single-center experience.

查看英文原题

Clinical outcome and immunophenotype of axicabtagene ciloleucel (axi-cel) and relmacabtagene autoleucel (relma-cel) in relapsed/refractory large B-Cell lymphoma on Chinese population: a single-center experience.

PubMed 2025/09/26(内容时间) Ann Hematol Q3 · IF 2.3(JCR 2025)

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研究概要

在该队列中,用于 r/r 大 B 细胞淋巴瘤的 CAR-T 治疗取得了高缓解率和令人鼓舞的生存结局,其中 axi-cel 相比 relma-cel 疗效更优,但 CRS 发生率更高。

中文摘要

靶向CD19的嵌合抗原受体(CAR)T细胞疗法治疗复发/难治性(r/r)大B细胞淋巴瘤疗效显著,因此阿基仑赛(axi-cel)和瑞基奥仑赛(relma-cel)已在中国获批。尽管取得这些进展,CAR-T 在亚洲人群中的真实世界数据仍有限,axi-cel与relma-cel的比较结局也研究不足。

本回顾性队列研究分析中国一家三级医院33例r/r大B细胞淋巴瘤患者接受商业化CD19 CAR-T 治疗的真实世界疗效和安全性。收集基线人口学特征、国际预后指数(IPI)评分、体能状态和遗传学特征;并在部分患者中评估CAR-T 制备前后的T细胞免疫表型,探讨其与临床结局的潜在关联。通过PET/CT评估临床应答,采用Kaplan-Meier方法分析生存。

33例患者中位年龄53岁,CAR-T 输注后3个月完全缓解率(CR)为76.7%。1年总生存率(OS)为72.3%,1年无进展生存率(PFS)为71.2%。T细胞表型分析显示,初始T细胞亚群与最终CAR-T 产品特征无显著关联。axi-cel的CR率高于relma-cel(100% vs 61.1%),但伴随更严重的细胞因子释放综合征(CRS)。relma-cel产品中干细胞样记忆T细胞(CCR7+ CD45RA+)比例较高的患者疗效较低,提示治疗获益可能存在一个理想的此类细胞比例范围。

本队列中,CAR-T 治疗r/r大B细胞淋巴瘤取得较高缓解率和良好生存结局;与relma-cel相比,axi-cel疗效更好,但CRS发生率更高。研究强调,CAR-T 产品需维持适宜的干细胞样记忆T细胞比例,以提高疗效。仍需前瞻性多中心研究在更大患者群体中验证这些发现。

展开英文摘要原文

Chimeric antigen receptor (CAR) T-cell therapy targeting CD19 has shown remarkable efficacy for treating relapsed or refractory (r/r) large B-cell lymphomas, leading to the approval of axicabtagene ciloleucel (axi-cel) and relmacabtagene autoleucel (relma-cel) in China. Despite these advances, limited real-world data exist for CAR-T therapies in Asian populations, and comparative outcomes between axi-cel and relma-cel remain understudied.

This retrospective cohort study analyzed real-world efficacy and safety data for commercial CD19 CAR-T therapies in 33 patients with r/r large B-cell lymphoma treated at a tertiary hospital in China. Baseline demographics, International Prognostic Index (IPI) scores, performance status, and genetic profiles were collected. Additionally, T-cell immunophenotypes were assessed in a subset of patients pre- and post-CAR-T manufacturing to evaluate potential associations with clinical outcomes. Clinical responses were measured using PET/CT, and survival was analyzed via Kaplan-Meier methods.

Among the 33 patients (median age 53), 76.7% achieved a complete response (CR) three months post-CAR-T infusion. One-year overall survival (OS) was 72.3%, and the one-year progression-free survival (PFS) was 71.2%. T-cell phenotype analysis revealed no significant association between initial T-cell subsets and final CAR-T product characteristics. Axi-cel demonstrated a higher CR rate (100%) compared to relma-cel (61.1%) but was associated with more severe cytokine release syndrome (CRS). Patients with a higher proportion of stem-like memory T cells (CCR7 + CD45RA+) in the relma-cel product exhibited reduced efficacy, suggesting an optimal range of stem-like memory cell proportions for therapeutic benefit.

In this cohort, CAR-T therapies for r/r large B-cell lymphoma yielded high response rates and promising survival outcomes, with axi-cel showing superior efficacy but higher CRS incidence compared to relma-cel. The study highlights the need for optimal stem-like memory T-cell proportions in CAR-T products for improved efficacy. Prospective multicenter studies are warranted to confirm these findings in larger patient populations.

论文信息

作者
Zhao D、Ruan J、Wei C、Zhang Y、Zhou D、Zhang W
第一作者单位
Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China.China
通讯作者单位
Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China. vv1223@vip.sina.com.China
期刊
Annals of hematology2025 Oct
原文标识
PubMed 41003738 · DOI 10.1007/s00277-025-06541-5