巴西血液学、血液治疗与细胞治疗协会 转基因细胞共识。VIII：嵌合抗原受体T细胞：临床前开发 - 安全性与疗效评估。
Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VIII: CAR-T cells: preclinical development - Safety and efficacy evaluation.
作者信息
Picanço-Castro Virginia, Bonamino Martín Hernan, Ramos Rodrigo Nalio, Guerino-Cunha Renato L, Oliveira Theo Gremen M, Rego Eduardo M
机构信息
Fundação Hemocentro de Ribeirão Preto, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, (HC FMRPUSP) Ribeirão Preto, SP, Brazil.
Divisão de Pesquisa Experimental e Translacional, Instituto Nacional do Câncer (INCA), Rio de Janeiro, RJ, Brazil; Vice-Presidência de Pesquisa e Coleções Biológicas da Fundação Oswaldo Cruz (VPPCB FIOCRUZ), Rio de Janeiro, RJ, Brazil.
出版信息
Hematol Transfus Cell Ther. 2021 Nov;43 Suppl 2(Suppl 2):S54-S63. doi: 10.1016/j.htct.2021.09.008.
Currently, there are four CAR-T products commercially available on the market. CAR-T cells have shown high remission rates and they represent an effective treatment option for patients with resistant or refractory B cell malignancies. Approval of these cell therapy products came after an extended period of preclinical evaluation that demonstrated unprecedented efficacy in this difficult-to-treat patient population. This review article outlines the main preclinical evaluations needed for CAR T cell product development.
目前，市场上有四种CAR-T产品可供商业使用。CAR-T细胞已显示出高缓解率，是耐药或难治性B细胞恶性肿瘤患者的一种有效治疗选择。这些细胞治疗产品是在经过长期的临床前评估后获得批准的，该评估证明了在这一难以治疗的患者群体中具有前所未有的疗效。这篇综述文章概述了CAR-T细胞产品开发所需的主要临床前评估。
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