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:Trial designs and endpoints for immune therapies in multiple myeloma.
Trial designs and endpoints for immune therapies in multiple myeloma.
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免疫疗法,包括 CAR-T 细胞、双特异性抗体和抗体药物偶联物,正在革新多发性骨髓瘤的治疗。在这篇综述中,我们讨论与免疫疗法相关的临床试验设计考量。我们首先审视与特定人群相关的问题,包括老年患者、肾功能损害患者、高危/髓外疾病患者以及既往接受过免疫治疗的患者。随后,我们重点介绍旨在优化剂量和方案选择的试验设计,探索基于临床前数据的合理联合治疗,并评估常用终点的细微差别。通过利用其药代动力学/药效学特征并运用新的转化医学见解,我们可以优化免疫疗法在多发性骨髓瘤中的应用。
Immune therapies, including CAR-T cells, bispecific antibodies, and antibody-drug conjugates, are revolutionizing the treatment of multiple myeloma. In this review, we discuss clinical trial design considerations relevant to immune therapies.
We first examine issues pertinent to specific populations, including elderly, patients with renal impairment, high-risk/extramedullary disease, and prior immune therapies.
We then highlight trial designs to optimize the selection of dose and schedule, explore rational combination therapies based on preclinical data, and evaluate the nuances of commonly used endpoints. By exploiting their pharmacokinetic/pharmacodynamic profiles and utilizing novel translational insights, we can optimize the use of immune therapies in multiple myeloma.
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