肿瘤细胞治疗研究
英文原题：Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
这是一项 II 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 230 例。试验地点：美国 · 伯明翰、吉尔伯特、小石城、洛杉矶（共 52 个中心）。登记号：NCT06297226。
不限性别 · ≥ 18 Years
纳入标准 * 根据国际骨髓瘤工作组（IMWG）标准，有记录的多发性骨髓瘤（MM）诊断。 * 接受过至少4类MM治疗[包括免疫调节药物（IMiD）、蛋白酶体抑制剂（PI）、抗CD38单克隆抗体、抗BCMA治疗]，且既往至少接受过3线治疗（LOT）。 * 根据 IMWG 2016 标准，有记录的疾病在最后一次抗骨髓瘤治疗方案期间或之后进展。 * 受试者在筛选期内必须有可测量的病灶。 * 美国东部肿瘤协作组（ECOG）体能状态评分为0或1。 排除标准 * 有活动性或既往中枢神经系统受累的MM病史。 * 单采术时尽管接受了适当的抗感染治疗，仍存在活动性全身性真菌、细菌、病毒或其他感染。单采术前28天内发生过严重感染、严重脓毒症或菌血症的受试者将被排除。 * 既往接受过任何靶向G蛋白偶联受体C类5组成员D（GPRC5D）的治疗，或在单采术前未完成所需洗脱期的情况下接受过其他MM治疗。 * 其他方案规定的纳入/排除标准同样适用。
Inclusion Criteria * Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria. * Received at least 4 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT). * Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria. * Participants must have measurable disease during screening. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria * Active or history of central nervous system involvement with MM. * Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded. * Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis. * Other protocol-defined Inclusion/Exclusion criteria apply.
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：Cohort 1: Best overall response (BOR) of partial response (PR) or better · The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT) · Up to approximately 5 years
次要终点：BOR of partial response (PR) or better；Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)；Minimal residual disease (MRD) negative status；Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC)；Duration of response (DOR) assessed by an IRC；Progression-free survival (PFS)；Overall survival (OS)；Overall response rate (ORR) assessed by an Investigator
本研究的目的是评估 Arlocabtagene Autoleucel（BMS-986393）在复发或难治性多发性骨髓瘤受试者中的有效性和安全性。
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
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