肿瘤细胞治疗研究
英文原题：A Study of VRd-based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With New-diagnosed Multiple Myeloma
A Study of VRd-based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With New-diagnosed Multiple Myeloma
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⚠ 该试验的登记信息已有 14 个月未更新， 页面上显示的「进行中（不再招募）」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 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：进行中（不再招募）。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：NCT05860036。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： 1. 年龄≥18岁且≤75岁； 2. 按IMWG诊断标准确诊新诊断多发性骨髓瘤（NDMM）； 3. 筛查时存在可测量疾病，符合以下任一项：血清单克隆副蛋白（M蛋白）≥1.0 g/dL或尿M蛋白≥200 mg/24小时；或轻链型骨髓瘤血清和尿液无可测量疾病，但血清游离轻链（FLC）≥10 mg/dL且血清κ/λ FLC比值异常； 4. 不适合接受自体干细胞移植（ASCT）的大剂量化疗，原因包括：年龄较大（≥65岁）；研究者评估不适合；ECOG体能状态3或4级；反复动员造血干细胞失败；或初始治疗阶段推迟大剂量化疗联合ASCT； 5. 骨髓样本经流式细胞术或病理学检查证实BCMA阳性； 6. 筛查血生化检查须按方案在入组前14天内完成，符合：总胆红素<2×ULN（Gilbert综合征患者<3×ULN）；AST和ALT<3×ULN；按Cockcroft-Gault公式计算的肌酐清除率≥30 mL/min； 7. 常规血液检查在7天内完成；筛查前14天内不得输注红细胞、接受G-CSF/GM-CSF/血小板激动剂或药物纠正，筛查前7天内不得输注血小板：白细胞≥1.5×10⁹/L，中性粒细胞绝对计数≥1.0×10⁹/L，血红蛋白≥70 g/L；骨髓浆细胞<50%者血小板≥75×10⁹/L，骨髓浆细胞≥50%者血小板≥50×10⁹/L； 8. 患者能够按研究建议接受预防性抗凝治疗； 9. 女性非哺乳、非妊娠，并同意研究期间及之后12个月内不妊娠；男性同意配偶在研究期间及之后12个月内不妊娠。 排除标准： 1. 原发性浆细胞白血病； 2. 有活动性淀粉样变的记录； 3. 多发性骨髓瘤累及中枢神经系统（CNS）； 4. 既往接受过任何BCMA靶向治疗或CAR-T 治疗； 5. 周围神经病变>2级，或基线时伴疼痛的周围神经病变>2级（不论目前是否接受药物治疗）； 6. 已知对糖皮质激素、硼替佐米、来那度胺或BCMA-CART细胞产品不耐受、过敏或有禁忌证； 7. HIV血清阳性； 8. 乙型肝炎感染； 9. 丙型肝炎感染； 10. 预期生存期<6个月； 11. 妊娠或哺乳期女性； 12. 任何影响患者吞咽片剂能力或可能影响研究药物吸收的活动性胃肠功能障碍； 13. 随机分组前2周内接受大手术（如全身麻醉），尚未完全康复，或计划研究期间接受手术； 14. 研究治疗前4周内接种减毒活疫苗； 15. 研究者认为可能影响研究治疗、依从性或知情同意能力的任何情况，包括但不限于严重精神或躯体疾病、症状/疾病； 16. 必需药物或支持治疗与研究治疗存在禁忌； 17. 任何可能干扰研究的疾病或并发症； 18. 不愿或无法遵守研究方案。
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years. 2. Participants with documented NDMM according to IMWG diagnostic criteria. 3. Measurable disease, at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. 4. Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age (≥65); or Ineligible evaluated by researchers; or Eastern Cooperative Oncology Group Performance Status grade of 3 or 4; or Repeated hematopoietic stem cell mobilization failure；or Deferral of high-dose chemotherapy with ASCT as initial treatment. 5. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination. 6. All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: a.TBIL\<2 x upper limit of normal (ULN) (\<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT \<3 x ULN.; c. Creatinine clearance ≥ 30mL/min (calculated using Cockroft-Gault formula). 7. Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : WBC ≥ 1.5 x 109/L, ANC ≥ 1.0 x 109/L, Hb ≥ 70 g/L PLT ≥ 75 x 109/L (if BMPC \< 50%) or PLT ≥ 50 x 109/L (if BMPC ≥ 50%). 8. Patients must be able to take prophylactic anticoagulant therapy as recommended by the study. 9. The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter. Exclusion Criteria: 1. Primary plasma cell leukemia. 2. Documented active amyloidosis. 3. Multiple myeloma with central nervous system (CNS) invasion. 4. Prior exposure to any BCMA-targeted therapy or CAR-T therapy. 5. Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy. 6. Known intolerance, hypersensitivity, or contraindication to glucocorticoids, bortezomib, lenalidomide, and BCMA-CART cellular products. 7. Seropositive for human immunodeficiency virus (HIV) 8. Hepatitis B infection 9. Hepatitis C infection 10. Life expectancy of \<6 months 11. Women who are pregnant or breastfeeding 12. Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of the studied treatment medication 13. Subjects had major surgery within 2 weeks before randomization (for example, general anesthesia), or is not fully recovered from the surgery, or surgery is arranged during study period. 14. Received live attenuated vaccine within 4 weeks prior to study treatment. 15. According to the researcher's judgment, any condition including but not limited to serious mental illness, medical illness, or other symptoms/conditions that may affect study treatment, compliance, or the capability of providing informed consent. 16. Necessary medication or supportive therapy is contraindicated with study treatment. 17. Any diseases or complications that may interfere with the study. 18. Patients are not willing to or cannot comply with study scheme.
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 3 months after CAR-T cell infusion · 3 months after CAR-T cell infusion
次要终点：Complete response rate (CRR)；Progression free survival (PFS)；Overall Survival (OS)；Duration of Remission(DOR)
VRd方案：硼替佐米1.3 mg/m²于第1、8、15、22天给药；来那度胺25 mg口服，于第1–21天给药；地塞米松40 mg于第1、8、15、22天给药，每周期28天。自体BCMA靶向CAR-T 细胞以2–4×10⁶个抗BCMA CAR阳性T细胞/kg为目标剂量静脉输注。受试者接受VRd诱导治疗、BCMA CAR-T 输注、VRd巩固治疗及来那度胺维持治疗。
这是一项单臂、开放标签研究，评估VRd（硼替佐米、来那度胺和地塞米松）方案联合BCMA CAR-T 治疗中国不适合移植的新诊断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 VRd(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with BCMA CAR-T in Chinese transplant-ineligible patients with newly diagnosed multiple myeloma
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