决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
我们评估了11例接受单一批次cemacabtagene ansegedleucel(cema-cel)治疗的大B细胞淋巴瘤患者,cemacabtagene ansegedleucel是一种异体抗CD19 CAR T产品。
英文原题:Follow-Up Evaluation for Gene-Therapy-Related Delayed Adverse Events After Participation in Pediatric Oncology Branch Clinical Trials
这是一项分期未标注的注册临床试验,评估抗 CD19 细胞治疗用于恶性肿瘤、血液系统恶性肿瘤、实体瘤的安全性、可行性及初步疗效。当前状态:邀请入组。计划入组 500 例。试验地点:美国 · 贝塞斯达(共 1 个中心)。登记号:NCT02315599。
不限性别 · ≥ 1 Year 且 ≤ 99 Years
纳入标准: • 经确认符合儿童肿瘤科(POB)基因工程细胞治疗临床试验条件、正在参加或曾参加该试验,并已接受或计划接受基因工程细胞治疗。 • 本方案所述监测和检测仅针对在美国国立卫生研究院(NIH)接受的基因工程细胞治疗。若细胞在其他机构给药,则不进行复制型逆转录病毒/慢病毒(RCR/RCL)监测和细胞持续性监测。
* INCLUSION CRITERIA: * Participants must be identified eligible for, participating in, or have participated in a POB genetically engineered cellular therapy clinical trial and have received/or be scheduled to receive a genetically engineered cellular therapy. * All monitoring and testing described in this protocol will pertain ONLY to genetically engineered cellular therapy received at the National Institutes of Health (NIH). RCR/RCL monitoring and persistence will NOT be followed for cells administered at another institution.
以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。
主要终点:Conduct long term safety evaluations after gene therapy · PCR results (for RCR/RCL, gene transduced cells) · Every 3 months X 1 year then annually X 15 years
筛查中、正在参加或曾参加 POB 基因治疗临床试验,且已接受或计划接受基因工程细胞治疗的患者。
背景:基因治疗通过改变人体细胞内的基因来治疗疾病,受到严格监管。接受该疗法者可能在数月甚至数年后出现问题,但其长期副作用尚不清楚,因此研究者拟对既往接受治疗者开展最长15年的研究随访。 目的:随时间评估基因工程细胞治疗的迟发不良反应,研究对象为曾参加美国国家癌症研究所儿童肿瘤科(POB)基因治疗试验者。 资格:目前或既往参加美国国家癌症研究所 POB 基因治疗研究者。 研究流程:基因改造细胞输注前采血;输注作为另一项研究的一部分进行。之后1年内至少每3个月到诊所或由当地医生随访一次,询问健康状况并采血;之后5年每年到诊所或由当地医生体检和采血;再后10年每年收集健康信息。参加者须向研究团队更新联系方式,研究人员也可能致电询问健康状况。若接受基因治疗时未满18岁,且在随访期间年满18岁,则须重新签署知情同意书。
Background: \- Gene therapy involves changing the genes inside the body s cells to stop disease. It is very closely regulated. People who have had this therapy may have problems months or even years later. Researchers do not know the long-term side effects, so they want to study people who have had the therapy. They want the study to continue over the next 15 years. Objective: \- To study over time the negative side effects from genetically engineered cellular therapy. This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy trials. Eligibility: \- People who are currently or were previously in a research study with gene therapy in the National Cancer Institute POB. Design: * Participants blood will be tested right before they get the genetically changed cells. They will get the cells as part of another study. * For the next year, they will come back to the clinic or see their doctor at home at least every 3 months. They will answer questions about their health and blood will be drawn. * For the next 5 years, they will go to the clinic or see their own doctor once a year. They will have physical exam and blood will be drawn. * For 10 years after that, they will be asked every year for health information. * Participants will keep their contact information up to date with researchers. They may be phoned for more health information. * If the participant was under 18 years old when given the gene therapy and turns 18 during this follow-up, they will be asked to sign a new consent form when they turn 18.
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