Four-year follow-up of LCAR-B38M in relapsed or refractory multiple myeloma: a phase 1, single-arm, open-label, multicenter study in China (LEGEND-2).
Four-year follow-up of LCAR-B38M in relapsed or refractory multiple myeloma: a phase 1, single-arm, open-label, multicenter study in China (LEGEND-2).
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DOI：
10.1186/s13045-022-01301-8
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发表时间：
2022-07-06
影响因子：
28.5
通讯作者：
中科院分区：
文献类型：
--
作者：
LCAR-B38M 是一种嵌合抗原受体 T 细胞产品，具有两个针对 B 细胞成熟抗原的结合域。我们之前的报告显示，在中位随访 2 年中，LCAR-B38M 对复发/难治性多发性骨髓瘤 (RRMM) 患者具有显着疗效。在这里，我们报告了中位随访 4 年的长期安全性和有效性数据。 LEGEND-2 是一项在中国四个注册中心进行的第一阶段、单臂、开放标签研究。 74 名 RRMM 参与者接受了 LCAR-B38M 治疗。使用环磷酰胺或环磷酰胺加氟达拉滨进行淋巴细胞清除。 LCAR-B38M的中位剂量为0.513 × 106细胞/kg，分三次输注或单次输注静脉内施用。主要目标是 LCAR-B38M 的安全性，次要目标是疗效。截至 2021 年 5 月 25 日，中位随访时间为 47.8 个月。所有患者均出现≥1 次不良事件 (AE)。 45/74 (60.8%) 例患者观察到 3 级 AE。 68/74（91.9%）例发生细胞因子释放综合征（CRS）； 7 名 (9.5%) 患有 ≥ 3 级 CRS。一名患者经历了 1 级中枢神经系统毒性。总体答复率为87.8%。 74 名患者中有 54 名 (73.0%) 达到完全缓解。中位无进展生存期为 18.0 个月，所有患者的中位总生存期尚未达到。中位缓解持续时间为 23.3 个月。 4 名患者在输注后超过 6 个月经历了病毒感染，4 名患者在 CAR-T 细胞转移后的中位时间 11.5 个月内出现了第二原发性非血液恶性肿瘤。 LCAR-B38M 疗法的 4 年随访数据证明了 RRMM 患者良好的长期安全性和持久的反应。试验注册ClinicalTrials.gov NCT03090659（于2017年3月27日追溯注册）； ChiCTR-ONH-17012285。在线版本包含可在 10.1186/s13045-022-01301-8 获取的补充材料。
LCAR-B38M is a chimeric antigen receptor T cell product with two binding domains targeting B cell maturation antigen. Our previous reports showed a remarkable efficacy of LCAR-B38M in patients with relapsed/refractory multiple myeloma (RRMM) at a median follow-up of 2 years. Here, we report long-term safety and efficacy data from a median follow-up of 4 years. LEGEND-2 was a phase 1, single-arm, open-label study conducted in four registered sites in China. Seventy-four participants with RRMM received LCAR-B38M treatment. Lymphodepletion was performed using cyclophosphamide or cyclophosphamide plus fludarabine. LCAR-B38M, at a median dose of 0.513 × 106 cells/kg, was intravenously administered either in three split infusions or in a single infusion. The primary objective was the safety of LCAR-B38M, and the secondary objective was efficacy. As of May 25, 2021, the median follow-up was 47.8 months. All patients experienced ≥ 1 adverse events (AEs). Grade ≥ 3 AEs were observed in 45/74 (60.8%) patients. Cytokine release syndrome (CRS) occurred in 68/74 (91.9%) cases; 7 (9.5%) had grade ≥ 3 CRS. One patient experienced grade 1 central nervous system toxicity. The overall response rate was 87.8%. Fifty-four out of 74 (73.0%) patients achieved complete response. The median progression-free survival was 18.0 months, and the median overall survival for all patients was not reached. The median duration of response was 23.3 months. Four patients experienced viral infection more than 6 months post-infusion, and four patients developed second primary non-hematological malignancies at a median time of 11.5 months post-CAR-T cell transfer. The 4-year follow-up data of LCAR-B38M therapy demonstrated a favorable long-term safety profile and a durable response in patients with RRMM. Trial registration Clinicaltrials.gov NCT03090659 (retrospectively registered on March 27, 2017); ChiCTR-ONH-17012285. The online version contains supplementary material available at 10.1186/s13045-022-01301-8.
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影响因子：
2.9
作者：
D'Agostino M;Boccadoro M;Smith EL
通讯作者：
Smith EL
DOI：
10.1084/jem.20031330
发表时间：
2004-01-05
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
O'Connor BP;Raman VS;Erickson LD;Cook WJ;Weaver LK;Ahonen C;Lin LL;Mantchev GT;Bram RJ;Noelle RJ
通讯作者：
Noelle RJ
影响因子：
20.3
作者：
Touzeau, Cyrille;Moreau, Philippe
通讯作者：
Moreau, Philippe
采用抗 BCMA CAR-T 细胞疗法及单倍相合造血干细胞移植成功治疗复发/难治性髓外多发性骨髓瘤：病例报告及当代文献综述
影响因子：
3.9
作者：
Qian Y;Qian Z;Zhao X;Pan W;Wei X;Meng H;Yang L;Xiao H
通讯作者：
Xiao H
影响因子：
158.5
作者：
Chari, Ajai;Vogl, Dan T.;Jagannath, Sundar
通讯作者：
Jagannath, Sundar