肿瘤细胞治疗研究
英文原题：CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
⚠ 该试验的登记信息已有 12 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 I 期注册临床试验，评估细胞治疗用于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 50 例。试验地点：美国 · 伯明翰、奥罗拉、迈阿密、列克星敦（共 16 个中心）。登记号：NCT05722418。
不限性别 · ≥ 18 Years
纳入标准： 1. 有文件记录确诊复发/难治性多发性骨髓瘤（MM），且存在可测量疾病（按 IMWG 诊断标准）。 2. 既往至少接受过3线 MM 治疗，其中至少一线包含蛋白酶体抑制剂（PI）、免疫调节药物（IMiD）和抗 CD38 单克隆抗体，可单药或联合给药。 3. ECOG 体能状态评分0或1。 4. 血液学、肾、肝、肺和心脏功能充分。 排除标准： 1. 既往接受过靶向任何抗原的 CAR-T 治疗。 2. 淋巴细胞清除前6周内接受过自体造血干细胞移植。 3. 淋巴细胞清除前6个月内接受过异基因造血干细胞移植。 4. 已知当前或既往有中枢神经系统受累。 5. 签署知情同意书前6个月内发生卒中或癫痫。 6. HIV 血清阳性或有 HIV 感染史。 7. 淋巴细胞清除前4周内接种活减毒疫苗。 8. 乙型肝炎感染。 9. 丙型肝炎感染。 10. 已知对 CB-011 或其辅料有危及生命的过敏、超敏反应或不耐受。
Inclusion Criteria: 1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.) 2. Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination. 3. Eastern Cooperative Oncology Group performance status grade of 0 or 1. 4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function. Exclusion Criteria: 1. Prior treatment with CAR-T cell therapy directed at any target. 2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion. 3. Allogeneic stem cell transplant within 6 months before lymphodepletion. 4. Known active or prior history of CNS involvement. 5. Stroke or seizure within 6 months of signing ICF. 6. Seropositive for or history of human immunodeficiency virus. 7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion. 8. Hepatitis B infection. 9. Hepatitis C infection. 10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
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：(Part A) Number of patients with dose limiting toxicities (DLT) · Number of patients with DLTs during the 28 days following the first administration of CB-011. · 28 days；(Part B) Overall Response Rate (ORR) · The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria. · 12 Months
A部分采用传统3+3设计，逐级增加 CB-011 剂量。B部分为扩展队列：最多纳入30名参加者，给予方案A确定的推荐剂量扩展剂量（RDE）/最大耐受剂量（MTD）和/或 II 期推荐剂量（RP2D）。
这项 I 期研究评估 CB-011（一种靶向 B 细胞成熟抗原〔BCMA〕的异基因嵌合抗原受体 T 细胞疗法）的安全性，确定最佳剂量，并评估其治疗复发或难治性多发性骨髓瘤的疗效。
This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).
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