肿瘤细胞治疗研究
英文原题：Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT
⚠ 该试验的登记信息已有 17 个月未更新， 页面上显示的「尚未开始招募」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 II 期注册临床试验，评估自体干细胞治疗多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 60 例。试验地点：中国 · 徐州（共 1 个中心，其中中国 1 个）。登记号：NCT06963866。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： 1. 年龄18至70岁（含两端）。 2. 预期生存期>12周。 3. 经体格检查、病理学评估、实验室检测和影像学检查确诊多发性骨髓瘤。 4. ALT 和 AST<正常值上限（ULN）的3倍。 5. Karnofsky 体能状态（KPS）评分>50%。 6. 适合接受自体造血干细胞移植（ASCT）。 排除标准： 1. 妊娠或哺乳期，或计划在未来6个月内妊娠。 2. 可行性筛查显示靶向淋巴细胞转导效率<10%，或在 CD3/CD28 共刺激下扩增倍数<5。 3. 有严重过敏或超敏反应史，尤其是对白细胞介素-2（IL-2）过敏。 4. 心、肺或脑等重要器官显著功能障碍。 5. 研究者判断不适合参加研究的其他情况。
Inclusion Criteria: 1. Age between 18 and 70 years (inclusive); 2. Estimated life expectancy of more than 12 weeks; 3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies; 4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN); 5. Karnofsky Performance Status (KPS) score \> 50%. 6. Eligible for ASCT. Exclusion Criteria: 1. Pregnant or lactating women, or women planning to become pregnant within the next six months; 2. Transduction efficiency of targeted lymphocytes \<10%, or expansion fold \<5× under CD3/CD28 co-stimulation, as determined by feasibility screening; 3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2); 4. Significant dysfunction of vital organs including the heart, lungs, or brain; 5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in 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：Progression-Free Survival (PFS) · Progression-Free Survival (PFS) is defined as the time from the date of CAR-T cell infusion to the date of disease progression or death from any cause, whichever occurs first. Disease progression will be determined based on the International Myeloma Working Group (IMWG) criteria. Patients who have not progressed or died will be censored at the date of last follow-up. · Up to 36 months after CAR-T infusion；Overall Survival (OS) · Overall Survival (OS) is defined as the time from the date of CAR-T cell infusion to death from any cause. Patients who are alive at the time of analysis will be censored at their last known date of follow-up. · Up to 36 months after CAR-T infusion
次要终点：Objective Response Rate (ORR)；MRD；Adverse Events (AE)
接受自体造血干细胞移植后再接受 BCMA CAR-T 治疗。
仅接受自体造血干细胞移植，不输注 CAR-T 细胞。
这项前瞻性研究比较自体造血干细胞移植后序贯抗 BCMA CAR-T 与单独自体造血干细胞移植治疗新诊断多发性骨髓瘤患者的效果。
This is a prospective study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.
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