肿瘤细胞治疗研究
英文原题：A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项分期未标注的注册临床试验，评估细胞治疗用于恶性肿瘤的安全性、可行性及初步疗效。当前状态：邀请入组。计划入组 60 例。试验地点：美国 · 丹佛、亚特兰大、韦斯特伍德、新不伦瑞克（共 7 个中心）。登记号：NCT06701201。
不限性别 · ≥ 18 Years
纳入标准： 仅在符合以下全部标准时，参加者方可入组： 1. 所有曾在Verismo Therapeutics申办的研究中接受任意剂量SynKIR CAR-T 细胞产品的成年参加者。 2. 参加者愿意且能够遵守研究要求。 排除标准： • 无特定排除标准。
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics. 2. Participant is willing and able to comply with the study requirements. Exclusion Criteria: There are no specific exclusion criteria.
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：To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product · Frequency and severity of delayed AEs considered related to SynKIR CAR T cell product · Up to 15 years from SynKIR CAR T cell product administration；To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product · Presence of RCL VSV-G DNA · Up to 15 years from SynKIR CAR T cell product administration
次要终点：To assess the long-term clinical efficacy of SynKIR CAR T cell product；To assess the long-term clinical efficacy of SynKIR CAR T cell product；To assess the persistence of SynKIR-modified T cells
既往在干预性试验中接受SynKIR-110的参加者。
既往在干预性试验中接受SynKIR-310的参加者。
本研究的主要目的是监测使用SynKIR CAR-T 细胞产品后可能出现的长期风险。
The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
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