肿瘤细胞治疗研究
英文原题：Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells
Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells
这是一项分期未标注的注册临床试验，评估细胞治疗用于淋巴瘤、B 细胞淋巴瘤、弥漫大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 50 例。试验地点：美国 · 帕洛阿尔托、路易维尔、达拉斯、休斯顿（共 5 个中心）。登记号：NCT04911478。
不限性别 · ≥ 18 Years
纳入标准： • 曾接受任一 Adicet 异基因 CAR-T 研究产品，且已完成核心治疗方案或提前退出。 • 愿意且能够遵守研究访视安排及其他方案要求。 • 能够签署书面知情同意书，并遵守其中列明的要求和限制。 排除标准：无具体排除标准。
Inclusion Criteria: * All patients who received any Adicet allogeneic CAR T investigational product and have either completed the core treatment protocol or have discontinued early * All patients who are willing and able to adhere to the study visit schedule and other protocol requirements. * Capable of giving signed informed consent which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and protocol Exclusion Criteria: * 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：Long-term safety of Adicet Bio allogeneic γδ CAR T cell products · Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies · 15 years
次要终点：Measure quantitative immunoglobulin and peripheral blood immunophenotyping；Monitor for the presence of replication competent retrovirus (RCR)；Duration of ADI-001 persistence；Overall Response Rate by Lugano Criteria；Duration of Response by Lugano Criteria；Progression Free Survival by Lugano Criteria；Time To Progression by Lugano Criteria；Overall Survival
本延续随访方案纳入既往参加 Adicet Bio 异基因 γδ CAR-T 细胞研究的所有受试者。治疗后最长随访15年。
本研究评估接受 Adicet Bio γδ CAR-T 产品后可能出现的长期副作用。参加者完成母干预研究后加入本研究。本研究不额外给予研究药物，但长期安全性随访期间可接受其他癌症治疗。自首次接受 Adicet Bio 异基因 γδ CAR-T 产品起随访15年，收集安全性、疗效、药代动力学和免疫原性数据，以评估长期安全性和生存。
The purpose of this study is to assess long-term side effects from subjects who receive an Adicet Bio γδ CAR T cell product. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years from the first administration of Adicet Bio allogeneic γδ CAR T cell product, subjects will be assessed for long-term safety and survival through collection of data that include safety, efficacy, pharmacokinetics and immunogenicity.
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