肿瘤细胞治疗研究
英文原题：Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
这是一项 II 期注册临床试验，评估细胞治疗用于多发性骨髓瘤、弥漫大 B 细胞淋巴瘤、急性淋巴细胞白血病的安全性、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 · 迈阿密、圣路易斯、奥斯汀、巴塞罗那（共 9 个中心）。登记号：NCT03628612。
不限性别 · ≥ 1 Year
纳入标准： 1. 患者必须在临床治疗研究中接受过AUTO CAR-T细胞治疗。 2. 患者必须在参加本研究前已签署长期随访研究的知情同意书。 3. 患者必须能够遵守研究要求。 排除标准： 1. 本研究无特定排除标准。
Inclusion Criteria: 1. Patients must have received an AUTO CAR T cell therapy on a clinical treatment study. 2. Patients must have provided informed consent for long-term follow-up study prior to participation. 3. Patients must be able to comply with the study requirements. Exclusion Criteria: 1. There are no specific exclusion criteria for this study.
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：Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy · Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy.
Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion. · For up to 15 years
次要终点：Overall Survival following first AUTO CAR T cell therapy infusion.；Duration of supportive care；Duration of response；Progression-free survival；Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion；Proportion of patients with detectable vector copy number (VCN) in peripheral blood；Testing for Insertional mutagenesis in case of a new malignancy
既往接受过 AUTO CAR T 细胞疗法治疗的患者
对接受 AUTO CAR T 细胞治疗的患者进行长期随访，随访时间最长至首次 AUTO CAR T 细胞治疗输注后 15 年。
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
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