Piñeyroa Juan A, Cid Joan, Lozano Miquel
Apheresis and Cellular Therapy Unit, Department of Hemotherapy and Hemostasis, ICMHO, Clínic Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain.
Transfus Med Hemother. 2022 Dec 22;50(2):98-104. doi: 10.1159/000528331. eCollection 2023 Apr.
The major drug regulatory agencies have approved chimeric antigen receptor (CAR) T cells for the treatment of some B-cell lymphoproliferative diseases. Their use is expanding, and new indications will be approved. Efficient mononuclear cell collection by apheresis providing enough T cells is a critical step in further CAR T-cell manufacturing process. It is important that apheresis units are prepared for the collection of the required T cells for manufacturing with the highest efficiency and safety for the patient.
Several series have studied different characteristics that could influence the collection efficiency of T cells for CAR T-cell manufacturing. Also, an effort has been made to identify predictors of the total number of target cells collected. Despite these publications and the large number of ongoing clinical trials, consensus protocols in apheresis are scarce.
The aim of this review was to summarize the set of measures described to optimize apheresis and ensure patient safety. Moreover, we also propose, in a practical approach, a way to apply this knowledge to the daily routine in the apheresis unit.
主要药物监管机构已批准嵌合抗原受体(CAR)T细胞用于治疗某些B细胞淋巴增殖性疾病。其应用正在不断扩大,新的适应证也将获批。通过单采高效采集单核细胞以提供足够的T细胞是进一步进行CAR T细胞制造过程中的关键步骤。重要的是,单采单位要为以最高效率和对患者的安全性采集制造所需的T细胞做好准备。
多个系列研究了可能影响CAR T细胞制造中T细胞采集效率的不同特征。此外,人们还努力确定所采集目标细胞总数的预测指标。尽管有这些出版物以及大量正在进行的临床试验,但单采方面的共识方案却很少。
本综述的目的是总结为优化单采和确保患者安全而描述的一系列措施。此外,我们还以一种实用的方法提出了一种将这些知识应用于单采单位日常工作的方式。