PHASE I SAFETY/FEASIBILITY: GENETICALLY MODIFIED AUTOLOGOUS T CELLS IN LYMPHOMA

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 复发的B细胞淋巴瘤除了干细胞移植外，用常规疗法是无法治愈的，干细胞移植是一种有毒的治疗方式，只能挽救20%-50%的复发疾病患者。因此，创新的新治疗方法显然是必要的。这项第一阶段研究将评估使用基因疗法治疗复发性或难治性套细胞淋巴瘤或惰性非霍奇金淋巴瘤患者的可行性、安全性、毒性和有效性。这项临床试验使用转基因免疫细胞，试图改善人体的免疫系统，以对抗淋巴瘤。免疫细胞将通过白细胞分离从患者体内取出，然后在实验室进行基因改造和大量扩增，然后分三次注入患者体内。12人将参加这项研究。前三名参与者只接受免疫细胞注射，其余人将接受同样的治疗，外加刺激免疫细胞生长的药物白介素2(IL-2)。在一些患者中，第二或第三剂量的细胞可能会被铟-111标记，以评估体内转运。这项研究将检查这种方法的安全性和毒性，患者的淋巴瘤对转基因免疫细胞的反应，这些细胞在体内停留多长时间，细胞在体内的哪里移动，以及身体是否对这些细胞产生免疫反应。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Relapsed B cell lymphomas are incurable with conventional therapies except stem cell transplantation, a toxic treatment modality which salvages only 20-50% of patients with recurrent disease. Innovative new treatment approaches are therefore clearly necessary. This phase I study will evaluate the feasibility, safety, toxicity, and efficacy of using gene therapy to treat patients with relapsed or refractory mantle cell or indolent non-Hodgkin's lymphomas. This clinical trial uses genetically modified immune cells to try to improve the body's immune system to fight lymphoma. Immune cells will be taken from the patient's body through leukapheresis, and then genetically modified and expanded to large numbers in a laboratory before being reinfused to the patient in three doses. Twelve people will take part in the study. The first three people who take part received immune cell infusions alone, and the remainder will receive the same treatment, plus the drug interleukin 2 (IL-2) to stimulate the immune cells to grow. In some patients, the second or third dose of cells may be labeled with Indium-111 for assessment of in vivo trafficking The study will examine the safety and toxicity of this approach, how a patient's lymphoma responds to the genetically modified immune cells, how long these cells remain in the body, where the cells travel in the body, and whether the body develops an immune response to these cells.