1 Institute of Cellular Therapeutics , Hannover Medical School, Hannover, Germany.
2 Institute of Clinical Immunology, University Hospital Leipzig , Leipzig, Germany.
Hum Gene Ther. 2018 May;29(5):559-568. doi: 10.1089/hum.2017.254. Epub 2018 Apr 5.
The adoptive transfer of chimeric antigen receptor (CAR)-modified T cells is attracting growing interest for the treatment of malignant diseases. Early trials with anti-CD19 CAR T cells have achieved spectacular remissions in B-cell leukemia and lymphoma, so far refractory, very recently resulting in the Food and Drug Administration approval of CD19 CAR T cells for therapy. With further applications and increasing numbers of patients, the reproducible manufacture of high-quality clinical-grade CAR T cells is becoming an ever greater challenge. New processing techniques, quality-control mechanisms, and logistic developments are required to meet both medical needs and regulatory restrictions. This paper summarizes the state-of-the-art in manufacturing CAR T cells and the current challenges that need to be overcome to implement this type of cell therapy in the treatment of a variety of malignant diseases and in a greater number of patients.
嵌合抗原受体 (CAR)-修饰 T 细胞的过继转移在恶性疾病的治疗方面引起了越来越多的关注。早期使用抗 CD19 CAR T 细胞的试验在 B 细胞白血病和淋巴瘤方面取得了显著的缓解效果，这些疾病以前是无法治愈的，最近甚至导致食品和药物管理局批准 CD19 CAR T 细胞用于治疗。随着进一步的应用和越来越多的患者，可重复生产高质量临床级 CAR T 细胞正成为一个越来越大的挑战。需要新的加工技术、质量控制机制和物流发展，以满足医疗需求和监管限制。本文总结了制造 CAR T 细胞的最新技术进展，以及在将这种细胞疗法应用于治疗多种恶性疾病和更多患者方面需要克服的当前挑战。
