■这是一项名为CARTITUDE-4的3期临床试验的摘要。该试验比较了抗癌疗法西塔卡塔那autoleucel(或cilta-cel)与多发性骨髓瘤患者的标准疗法,一种影响特定类型血细胞的癌症,称为浆细胞。研究中的人已经接受过1到3种多发性骨髓瘤的治疗方法,包括一种叫做来那度胺的常见抗骨髓瘤治疗,但是他们的多发性骨髓瘤没有好转。
■这项研究的419名参与者中约有一半接受了cilta-cel,而另一半接受标准疗法,或常用于治疗多发性骨髓瘤的疗法。接受cilta-cel的参与者从他们的血液中收集了一种称为T细胞的免疫细胞,并进行了基因修饰以识别骨髓瘤细胞上发现的特定蛋白质。这些修饰的T细胞,其中包括西塔塞尔,然后注入血液。
■经过大约1年的研究,与标准治疗组(49%)相比,cilta-cel组(76%)更多的参与者还活着,他们的癌症没有恶化.两组中最常见的副作用是感染和低血细胞计数。细胞因子释放综合征(由免疫系统过度激活引起的潜在严重副作用)很常见,但大多是轻度的。神经毒性(包括免疫效应细胞相关神经毒性综合征,会引起头痛等症状,意识的改变,和记忆的困难,注意,说话,或理解他人)较不常见,在使用cilta-cel治疗的参与者中,有20.5%的参与者报告。
在CARTITUDE-4中,与接受标准治疗的参与者相比,接受cilta-cel治疗的参与者在接受cilta-cel12个月后表现出改善,并且在疾病控制下存活。临床试验注册:NCT04181827(CARTITUDE-4)(ClinicalTrials.gov)。
UNASSIGNED: This is a summary of a phase 3 clinical trial called CARTITUDE-4. This trial compared the anti-cancer therapy ciltacabtagene autoleucel (or cilta-cel) with standard therapies in people who have multiple myeloma, a cancer that affects specific kinds of blood cells called plasma cells. The people in the study had been treated with 1 to 3 previous treatments for multiple myeloma, including a common anti-myeloma treatment called lenalidomide, but their multiple myeloma did not get better.
UNASSIGNED: About half of the 419 participants in this study received cilta-cel, while the other half received standard therapies, or therapies that are commonly used to treat multiple myeloma. Participants who received cilta-cel had a type of immune cell called T cells collected from their blood and genetically modified to recognize a specific protein found on myeloma cells. These modified T cells, which comprise cilta-cel, were then infused back into the bloodstream.
UNASSIGNED: After approximately 1 year in the study, more participants were alive without their cancer getting worse in the cilta-cel group (76%) than in the standard therapies group (49%). The most common side effects in both groups were infections and low blood cell counts. Cytokine release syndrome (a potentially serious side effect caused by overactivation of the immune system) was common but mostly mild. Neurotoxicities (including immune effector cell-associated neurotoxicity syndrome, which can cause symptoms such as headaches, changes in consciousness, and difficulty with memory, attention, speaking, or understanding others) were less common and were reported in 20.5% of participants treated with cilta-cel.
UNASSIGNED: In CARTITUDE-4, more participants treated with cilta-cel showed improvements and were alive with control of their disease 12 months after receiving cilta-cel compared with participants who received standard therapies.Clinical Trial Registration: NCT04181827 (CARTITUDE-4) (ClinicalTrials.gov).