肿瘤细胞治疗研究
英文原题：Long-term Study to Evaluate Safety and Persistence of GF-CART01
这是一项分期未标注的注册临床试验，评估细胞治疗用于弥漫大 B 细胞淋巴瘤、滤泡性淋巴瘤、大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：邀请入组。计划入组 18 例。试验地点：中国 · 台北（共 1 个中心，其中中国 1 个）。登记号：NCT06985576。
不限性别
纳入标准： 1. 既往参加GF-CART01研究（方案编号：GF-01-01）并接受GF-CART01输注。 2. 受试者或其法定监护人自愿参加研究并签署知情同意书。 3. 根据研究者判断，愿意且能够遵守方案规定的要求、说明和限制。 排除标准： • 无。
Inclusion Criteria: 1. Subjects previously enrolled in the study of GF-CART01 (Protocol No.: GF-01-01) and received GF-CART01 infusion 2. Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent 3. Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement Exclusion Criteria: None
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 GF-CART01 after infusion · Percentage of subjects with ≥ grade 3 GF-CART01-related adverse events, serious adverse events (SAEs), adverse events of special interest (AESIs) · up to 15 years after GF-CART01 infusion
次要终点：GF-CART01 persistence；Efficacy of GF-CART01
邀请曾参加GF-01-01初始研究并接受GF-CART01治疗的受试者参加本随访研究，无论其是否完成初始研究。
这项观察性研究旨在了解细胞输注后最长15年内GF-CART01的长期安全性。
The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.
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