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

I 期安全性/可行性：转基因自体 T 细胞治疗淋巴瘤

• 批准号: 7603429
• 负责人: Oliver W. Press
• 金额: $ 0.35万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603429
• 关键词: Autologous; B-Cell Lymphomas; Cells; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Funding; Grant; Immune; Immune response; Immune system; Indium-111; Indolent; Infusion procedures; Institution; Interleukin-2; Label; Laboratories; Leukapheresis; Lymphoma; Modality; Non-Hodgkin' s Lymphoma; Numbers; Patients; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Recurrent disease; Refractory; Relapse; Research; Research Personnel; Resources; Safety; Source; Stem cell transplant; Toxic effect; Travel; United States National Institutes of Health; fighting; gene therapy; improved; in vivo; innovation; neuronal cell body; trafficking

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 复发性 B 细胞淋巴瘤无法用传统疗法治愈，除非干细胞移植，这是一种有毒的治疗方式，只能挽救 20-50% 的复发性疾病患者。 因此，创新的新治疗方法显然是必要的。 该一期研究将评估使用基因疗法治疗复发或难治性套细胞或惰性非霍奇金淋巴瘤患者的可行性、安全性、毒性和疗效。 这项临床试验使用基因改造的免疫细胞来尝试提高人体的免疫系统来对抗淋巴瘤。 免疫细胞将通过白细胞分离术从患者体内取出，然后在实验室进行基因改造并扩增至大量，然后分三剂回输给患者。 十二人将参加这项研究。 前三名参与者仅接受免疫细胞输注，其余人将接受相同的治疗，并添加药物白细胞介素 2 (IL-2) 来刺激免疫细胞生长。 在一些患者中，第二剂或第三剂细胞可能会用Indium-111标记，以评估体内运输。该研究将检查这种方法的安全性和毒性、患者的淋巴瘤如何对转基因免疫细胞做出反应、这些细胞在体内保留多长时间、细胞在体内移动的位置以及身体是否对这些细胞产生免疫反应。