肿瘤细胞治疗研究
英文原题：BCMA CAR-T for Dynamic High-risk Multiple Myeloma
BCMA CAR-T for Dynamic High-risk Multiple Myeloma
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。
⚠ 该试验的登记信息已有 14 个月未更新， 页面上显示的「招募中」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 BCMACAR-T 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：招募中。计划入组 40 例。试验地点：中国 · 天津（共 1 个中心，其中中国 1 个）。登记号：NCT06880393。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准：已获知情并自愿签署知情同意书；年龄18-75岁（含）；有可测量疾病，至少符合以下一项：血清蛋白电泳（SPEP）检出血清M蛋白≥1 g/dL（>10 g/L），或IgA/IgD型骨髓瘤的可定量IgA或IgD；尿M蛋白≥200 mg/24小时；如血清和尿M蛋白均未达到上述阈值，则游离轻链（FLC）比值异常（正常范围0.26-1.65）且受累血清FLC≥100 mg/L。既往仅接受过一线标准抗骨髓瘤治疗，包括至少一种蛋白酶体抑制剂、一种免疫调节剂和皮质类固醇的诱导治疗；序贯自体造血干细胞移植或巩固治疗；以及以蛋白酶体抑制剂或免疫调节剂为基础的维持治疗。至少符合一项动态高危标准：早期复发，即一线治疗开始后18个月内进展/复发（包括自体造血干细胞移植后12个月内进展/复发）；原发难治，即诱导治疗4个周期后未达到至少微小缓解（MR）；复发时出现新遗传异常，包括1q增加、del(17p)或TP53突变。流式细胞术或骨髓免疫组化确认骨髓瘤细胞表达BCMA靶抗原。排除标准：原发性浆细胞白血病；合并淀粉样变；中枢神经系统受累；既往接受BCMA靶向治疗或CAR-T 细胞治疗；自体造血干细胞移植后3个月内疾病进展或复发。
Inclusion Criteria: 1. Be informed and voluntarily sign the Informed Consent Form (ICF). 2. Age between 18 and 75 years (inclusive). 3. Have measurable disease meeting at least one of the following criteria: Serum M-protein ≥1 g/dL (\>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65) and involved serum FLC ≥100 mg/L. 4. Have received only one line of standard anti-myeloma therapy, including: Induction therapy with at least one proteasome inhibitor, one immunomodulatory agent, and corticosteroids; Sequential autologous hematopoietic stem cell transplantation or consolidation therapy; Maintenance therapy based on either a proteasome inhibitor or an immunomodulatory agent. 5. Meet at least one of the following dynamic high-risk criteria: Early relapse: Disease progression or relapse within 18 months of starting first-line therapy, including progression or relapse within 12 months post-autologous hematopoietic stem cell transplantation; Primary refractory disease: Failure to achieve at least minimal response (MR) after four cycles of induction therapy; Relapse with new genetic abnormalities: Gain(1q), del(17p), or TP53 mutation. 6. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry. Exclusion Criteria: 1. Primary plasma cell leukemia. 2. Concurrent amyloidosis. 3. Involvement of the central nervous system (CNS). 4. Previous treatment with BCMA-targeted therapy or CAR-T cell therapy. 5. Disease progression or relapse within 3 months of autologous hematopoietic stem cell transplantation.
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：Safety and Tolerability · The incidence of treatment-emergent adverse events (TEAEs) · Up to 2 year；MRD-negative rate · achieving MRD-negative, as determined by NGS/NGF after consolidation treatment · within 3 months after BCMA CAR-T infusion；Persistent MRD-negative rate · Persistent MRD-negative rate more than 12 months · Up to 2 year
次要终点：Progression free survival (PFS)；Complete response rate (CRR)
自体BCMA靶向CAR-T 细胞，经静脉输注，目标剂量为2-4×10^6个抗BCMA CAR阳性T细胞/kg。
以上邮箱 / 电话是登记库里的申办方联系方式（+86，中国），通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
这是一项单臂、开放标签研究，旨在评估BCMA CAR-T 治疗动态高危多发性骨髓瘤患者的疗效和安全性。
This is a single-arm, open-label study to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma
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