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
idecabtagene vicleucel 或 ciltacabtagene autoleucel 治疗复发/难治性多发性骨髓瘤：一项国际多中心研究
英文原题：Idecabtagene vicleucel or ciltacabtagene autoleucel for relapsed or refractory multiple myeloma: An international multicenter study.
查看英文原题
Idecabtagene vicleucel or ciltacabtagene autoleucel for relapsed or refractory multiple myeloma: An international multicenter study.
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中文摘要
Idecabtagene vicleucel（ide-cel）和 ciltacabtagene autoleucel（cilta-cel）已彻底改变了复发/难治性多发性骨髓瘤（RRMM）的治疗，但缺乏直接比较。利用一个国际多中心 RRMM 队列，我们比较了 ide-cel（n = 162）与 cilta-cel（n = 42）的结局。研究的共同主要疗效终点为总缓解率（ORR）和无进展生存期（PFS）。共同主要安全性终点为细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）的发生率。从单采到输注的中位周转时间 ide-cel 为 47 天，而 cilta-cel 为 68 天（p < 0.001）。cilta-cel 显示出显著更高的 ORR（93% vs. 79%；p < 0.001），第 30 天完全缓解率为 48% 对 26%（p < 0.001）。
cilta-cel 的 10 个月 PFS 和总生存期（OS）为 82% 和 90%，而 ide-cel 为 47% 和 77%（p < 0.001 和 p = 0.06），并且在多变量调整后证实了 cilta-cel 的结局更优。CRS 和 ICANS 的发生率似乎相似（cilta-cel 为 81% 和 19%，ide-cel 为 85% 和 19%），而 cilta-cel 组中 10% 和 7% 对 ide-cel 组中 4% 和 2% 出现严重 CRS 和 ICANS 3-4 级，ide-cel 的 CRS 发生显著更早（中位，2 天 vs. 4 天；p < 0.001）。非复发死亡率 cilta-cel 为 5%，ide-cel 为 3%（p = 0.51）。cilta-cel 显示 CAR-T 扩增峰值较晚，在第 14 天，而 ide-cel 在第 7 天，同时 cilta-cel 扩增与 ICANS 相关。
我们的研究提供了真实世界证据，表明在三类暴露的 RRMM 中，与 ide-cel 相比，cilta-cel 与更优的结局和不同的细胞动力学相关。
展开英文摘要原文
Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel) have revolutionized the treatment of relapsed/refractory multiple myeloma (RRMM), but direct comparisons are lacking. Leveraging an international multicenter RRMM cohort, we compared the outcome of ide-cel ( n = 162) versus cilta-cel ( n = 42). Co-primary efficacy endpoints of the study were overall response rate (ORR) and progression-free survival (PFS). Co-primary safety endpoints were the incidence of cytokine release syndrome (CRS) and immune-effector cell-associated neurotoxicity syndrome (ICANS). Median turnaround time between apheresis and infusion was 47 days for ide-cel versus 68 days for cilta-cel ( p < 0. 001). Cilta-cel showed significantly higher ORR (93% vs. 79%; p < 0.
001), with complete response at Day 30 of 48% versus 26% ( p < 0. 001). The 10-month PFS and overall survival (OS) was 82% and 90% for cilta-cel versus 47% and 77% ide-cel ( p < 0. 001 and p = 0. 06), and improved outcome for cilta-cel was confirmed after multivariable adjustment.
Incidence of CRS and ICANS appeared similar (81% and 19% for cilta-cel versus 85% and 19% for ide-cel), while 10% and 7% in the cilta-cel group versus 4% and 2% in the ide-cel group showed severe CRS and ICANS grade 3-4, with CRS occurring significantly earlier for ide-cel (median, 2 days vs. 4 days; p < 0. 001). Nonrelapse mortality was 5% for cilta-cel versus 3% for ide-cel ( p = 0. 51). Cilta-cel showed later peak of CAR-T expansion at Day 14 versus Day 7 for ide-cel, while cilta-cel expansion was associated with ICANS.
Our study provides real-world evidence that cilta-cel was associated with superior outcomes and distinct cellular dynamics versus ide-cel in triple-class exposed RRMM.
论文信息
- 作者
- Merz M、Albici AM、von Tresckow B、Rathje K、Fenk R、Holderried T、Müller F、Tovar N
- 第一作者单位
- Department of Hematology, Cellular Therapy, Hemostaseology and Infectious Diseases Universitätsklinikum Leipzig Leipzig Germany.Germany
- 通讯作者单位
- Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation University Medical Center Hamburg-Eppendorf Hamburg Germany.Germany
- 期刊
- HemaSphere2025 Jan
- 原文标识
- PubMed 39822585 · DOI 10.1002/hem3.70070
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