肿瘤细胞治疗研究
英文原题：ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)
这是一项 I/II 期注册临床试验，评估自体造血干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 20 例。试验地点：中国 · 天津（共 1 个中心，其中中国 1 个）。登记号：NCT05632380。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： • 适合接受移植的患者，男性或女性，年龄18至70岁。 • 超高危多发性骨髓瘤，定义为一线VRD为基础治疗失败或应答不满意，可伴或不伴多种高危细胞遗传学特征。 • 肝、肾、骨髓及心功能足够。 • ECOG体能状态评分0至1。 • 有生育能力的男性和女性须同意在研究期间采取避孕措施。 排除标准： • 已知对C-CAR088细胞产品的成分或辅料过敏。 • 既往接受过异基因HSCT或自体HSCT。 • 中枢神经系统受累。 • 签署知情同意书前6个月内有卒中或惊厥史。 • 自身免疫性疾病、免疫缺陷或需接受免疫抑制剂治疗的疾病。 • 未控制的活动性感染；活动性HBV、HCV感染；HIV或梅毒感染。 • 严重心脏、肝脏、肾脏或代谢性疾病。 • 单采前既往抗肿瘤治疗的洗脱期不足。 • 既往接受过CAR-T细胞治疗、基因修饰T细胞治疗或靶向BCMA治疗。 • 研究者认为可能混淆试验结果、影响患者安全参加研究或遵守研究要求的任何疾病、治疗或实验室异常。
Inclusion Criteria: * Transplantation eligible patients, male or female, aged 18 to 70 years * Ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features * Adequate liver, renal, bone marrow, and heart function * Eastern Cooperative Oncology Group (ECOG) Performance status 0-1. * Male and female of reproductive potential must agree to use birth control during the study. Exclusion Criteria: * Known allergies to the components or excipients of the C-CAR088 cell product * Prior allogenic HSCT, or ASCT * CNS involvement * Stroke or convulsion history within 6 months prior to signing ICF * Autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment * Uncontrolled active infection; active HBV, HCV infection; HIV or syphilis Infection * Severe heart, liver, renal or metabolism disease * Inadequate wash-out time for previous anti-tumor treatments prior to apheresis * Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history * History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
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：Incidence rate and severity of adverse events (AE) · Incidence rate and severity of adverse events (AE) · 24 months
次要终点：Progression free survival (PFS)；MRD negativity rate；Overall response rate (ORR)；Duration of response (DOR)；Time to response (TTR)；Overall Survival (OS)；Cmax (maximal plasma concentration)；Tmax (Time to reach the maximal plasma conceration)
患者接受ASCT，随后单次输注C-CAR088。
这是一项I/II期、单臂、开放研究，评估自体造血干细胞移植联合C-CAR088（一种自体BCMA CAR-T细胞产品）用于超高危多发性骨髓瘤患者的治疗。超高危定义为一线VRD为基础治疗失败或应答不满意，可伴或不伴多种高危细胞遗传学特征。
This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.
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