肿瘤细胞治疗研究
英文原题：Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated 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 45 例。试验地点：欧洲 · 耶拿（共 1 个中心）。登记号：NCT07825064。
不限性别 · ≥ 18 Years
纳入标准： * 筛选时及研究治疗给药开始前即刻的东部肿瘤协作组（ECOG）体能状态评分为 0 或 1。 * 既往接受过一至四线治疗，包括既往接受过靶向 B 细胞成熟抗原（BCMA）的嵌合抗原受体（CAR）T 细胞治疗 * 根据国际骨髓瘤工作组（IMWG）诊断标准确诊多发性骨髓瘤 * 曾暴露于三类药物，即在既往任何一线治疗中接受过抗 CD38 治疗、蛋白酶体抑制剂（PI）和来那度胺 * 受试者在筛选期间必须有可测量病灶 排除标准： * 已知淀粉样变性病史（例如，组织活检刚果红染色阳性或等效结果，或血清淀粉样 P 成分扫描中有相关记录） * 浆细胞白血病，或循环浆细胞计数超过 500 cells/µL 或占外周血白细胞的 5% * 对 mAb 治疗（或重组抗体相关融合蛋白）有严重过敏或过敏反应史，或已知对 cevostamab 任何辅料过敏 * 可能显著影响口服药物吸收的胃肠道（GI）疾病 * 已知有活动性中枢神经系统（CNS）受累，或表现出 MM 脑膜受累的临床体征。如怀疑存在上述任一情况，则要求全脑 MRI 和腰椎细胞学检查结果为阴性。
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to the start of administration of study treatment. * Received one to four lines of prior therapy, including prior B-cell maturation antigen (BCMA)-targeting Chimeric Antigen Receptors (CAR) T-cell therapy * Multiple Myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria * Is triple-class exposed, i.e. received anti- cluster of differentiation 38 (CD38) therapy, a proteasome inhibitor (PI) and lenalidomide in any prior line * Participants must have measurable disease during screening Exclusion Criteria: * Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan) * Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/µL or 5% of the peripheral blood white cells * History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or known hypersensitivity to any of the excipients of cevostamab * Gastrointestinal (GI) disease that might significantly alter absorption of oral drugs * Known active Central Nervous System (CNS) involvement, or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole-brain MRI and lumbar cytology are required.
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：Overall Response Rate (ORR) as assessed by an Independent Review Committee · Up to approximately 3 years
次要终点：ORR, as assessed by the Investigator；Rate of Very Good Partial Response (VGPR) or Better；Complete Response/Stringent Complete Response (CR/sCR) Rate；Duration of Response (DOR)；Progression-free Survival (PFS)；Overall Survival (OS)；MRD-negative CR rate at 9 months measured in bone marrow aspirate by next-generation sequencing (NGS)；Overall MRD-Negative Complete Response Rate
本研究中，Cevostamab将与泊马度胺和地塞米松联合作为试验性治疗。受试者将按照方案中的计划接受Cevostamab治疗。
本研究的目的是评估 cevostamab 联合泊马度胺和地塞米松（CevosPd）在多发性骨髓瘤（MM）患者中的疗效和安全性，这些患者既往接受过一至四线治疗，并且曾暴露于抗白细胞分化抗原38（CD38）抗体、来那度胺、一种蛋白酶体抑制剂（PI）以及一种靶向B细胞成熟抗原（BCMA）的嵌合抗原受体（CAR）T细胞疗法。
The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.
MEMBER ACCOUNT
登录成功会直接打开下一页。
