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.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Two-year follow-up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study.
Two-year follow-up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study.
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在RELIANCE研究中,relmacabtagene autoleucel(relma-cel)用于三线复发/难治性(R/R)滤泡性淋巴瘤(FL)治疗取得了显著临床结局。主要终点为治疗后3个月的完全缓解率(CRR);关键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)以及不良事件(AE)的发生率和严重程度。接受relma-cel治疗的患者共28例,中位年龄54岁(范围:36–71岁),超过60%的患者既往接受过3线全身治疗。中位随访时间为24.4个月。此前主要分析集(n=27)报告的3个月CRR为85.2%,3个月总缓解率为100.0%。DOR、PFS和OS中位数均未达到。本文更新结果显示,估算的2年PFS率和OS率分别为80.3%和100%。治疗开始后90天内(N=28),无患者出现3级细胞因子释放综合征;仅1例接受100×10^6个CAR-T 细胞治疗的患者出现3级神经毒性。中性粒细胞减少症是最常见的3级治疗期间不良事件(39.3%)。未发生导致死亡的不良事件。在R/R FL患者中,relma-cel在2年随访期间实现了持久缓解,安全性可管理,且未出现新的安全性信号(ClinicalTrials.gov:NCT04089215)。
Relmacabtagene autoleucel (relma-cel) demonstrated significant clinical outcomes for 3 lines of treatment for relapsed or refractory (R/R) follicular lymphoma (FL) in the RELIANCE study. The primary end-point was the complete response rate (CRR) at 3 months. Key secondary end-points included the duration of response (DOR), progression-free survival (PFS), overall survival (OS) and frequency/severity of adverse events (AEs). Relma-cel-treated patients (N = 28) had a median age of 54 years (range: 36-71 years), and more than 60% of the patients received 3 lines of prior systemic therapies. The median follow-up was 24. 4 months. As previously reported, in the primary analyses set (n = 27), the 3-month CRR was 85.
2% and the 3-month overall response rate was 100. 0%. The median DOR, PFS and OS were not reached. As updated in this article, the estimated 2-year PFS and OS rates were 80. 3% and 100% respectively. During the 90-day treatment-emergent period (N = 28), no patients had cytokine release syndrome of grade 3, and neurological toxicity of grade 3 occurred in only one patient treated with 100 10 6 chimeric antigen receptor T cells.
Neutropenia (39. 3%) was the most common grade 3 treatment-emergent adverse event. There were no AEs leading to death. Relma-cel demonstrated durable remissions and manageable safety without new safety signals during the 2-year follow-up in patients with R/R FL (ClinicalTrials. gov, NCT04089215).
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