肿瘤细胞治疗研究
英文原题：Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
这是一项分期未标注的注册临床试验，评估细胞治疗用于黑色素瘤、非霍奇金淋巴瘤、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：招募中。计划入组 40 例。试验地点：欧洲 · 柏林、科隆、埃尔朗根、哥廷根（共 7 个中心）。登记号：NCT06508775。
不限性别
纳入标准： • 患者在一项母试验中接受Miltenyi CAR-T细胞治疗，且在入组长期随访前至少已治疗12个月。 • 患者在入组前已提供知情同意。 排除标准： • 无排除标准。
Inclusion Criteria: * Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parent trials at least 12 months prior to enrollment in long-term follow-up. * Patient has provided informed consent prior to enrollment. Exclusion Criteria: * No 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：Adverse Events · Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies · through study completion, up to 14 years
次要终点：Lymphocyte count；Height；Weight；Tanner staging for pediatric patients；Menstruation status for pediatric patients；RCL；Relapse / Progression；Detectable Transgene levels
评估Miltenyi CAR-T治疗的长期安全性和疗效。
本长期随访试验旨在评估Miltenyi CAR-T治疗的长期安全性和疗效。
The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.
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