肿瘤细胞治疗研究
英文原题：Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
这是一项 II 期注册临床试验，评估 CD19 细胞治疗用于大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 100 例。试验地点：中国 · 上海（共 1 个中心，其中中国 1 个）。登记号：NCT07613788。
不限性别 · ≥ 18 Years
纳入标准： * 能够理解并自愿签署书面知情同意书； * 年龄≥18岁； * 组织学确诊大B细胞淋巴瘤，且表达CD19和CD20； * 至少接受过1线全身治疗后疾病复发或难治； * 既往治疗须包括含蒽环类药物的化疗方案及抗CD20单克隆抗体； * 研究者认为适合接受格菲妥单抗和CD19 CAR-T细胞治疗； * 至少具有一项高危特征，包括结外受累、巨大肿块或TP53异常； * ECOG体能状态评分0–2分； * 预期生存期至少12周； * 研究者判断骨髓、肝、肾、肺及心功能充分； * 有生育能力的受试者同意在研究期间采取有效避孕措施； * 研究者判断受试者能够且愿意遵守研究方案。 排除标准： * 对任何研究治疗或相关化合物有超敏反应史； * 活动性或未控制感染，需要全身治疗； * 有异基因造血干细胞移植或器官移植史； * 存在方案定义的未控制或有临床意义的病毒感染； * 已知淋巴瘤累及中枢神经系统，或有可能干扰研究治疗/安全性评估的有临床意义中枢神经系统疾病； * 严重或未控制的心血管疾病； * 可能干扰研究治疗或安全性评估的严重自身免疫性或免疫介导性疾病； * 已知或疑似噬血细胞性淋巴组织细胞增多症病史； * 筛查前近期发生血栓栓塞事件； * 筛查前5年内有其他恶性肿瘤史，但已充分治疗的原位癌或非黑色素瘤皮肤癌除外； * 入组前方案规定期限内接受过禁用抗癌治疗、免疫抑制治疗、减毒活疫苗或其他禁用治疗； * 妊娠期或哺乳期女性，或计划在研究期间妊娠者； * 同时参加其他干预性临床试验； * 需要使用且无法停用或替换的禁用合并用药； * 研究者认为不适合接受研究治疗或参加研究的任何情况。
Inclusion Criteria: * Able to understand and voluntarily sign the written informed consent form. * Age 18 years or older. * Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression. * Relapsed or refractory disease after at least one prior line of systemic therapy. * Prior treatment must have included an anthracycline-containing chemotherapy regimen and an anti-CD20 monoclonal antibody. * Considered suitable by the investigator to receive glofitamab and CD19 CAR-T cell therapy. * Presence of at least one high-risk feature, including extranodal involvement, bulky disease, or TP53 abnormality. * ECOG performance status of 0 to 2. * Life expectancy of at least 12 weeks. * Adequate bone marrow, hepatic, renal, pulmonary, and cardiac function as determined by the investigator. * Participants of reproductive potential must agree to use effective contraception during the study period. * Able and willing to comply with the study protocol, in the investigator's judgment. Exclusion Criteria: * History of hypersensitivity to any study treatment or related compounds. * Active or uncontrolled infection requiring systemic treatment. * History of allogeneic hematopoietic stem cell transplantation or organ transplantation. * Uncontrolled or clinically significant viral infection as defined by the protocol. * Known central nervous system involvement by lymphoma or clinically significant central nervous system disease that may interfere with study treatment or safety assessment. * Severe or uncontrolled cardiovascular disease. * Severe autoimmune disease or immune-mediated disease that may interfere with study treatment or safety assessment. * Known or suspected history of hemophagocytic lymphohistiocytosis. * Recent thromboembolic event before screening. * History of another malignancy within 5 years before screening, except adequately treated carcinoma in situ or non-melanoma skin cancer. * Receipt of prohibited anticancer therapy, immunosuppressive therapy, live attenuated vaccine, or other prohibited treatment within the protocol-specified period before enrollment. * Pregnant or breastfeeding women, or participants planning pregnancy during the study period. * Concurrent participation in another interventional clinical trial. * Need for prohibited concomitant medications that cannot be discontinued or substituted. * Any condition that, in the investigator's judgment, makes the participant unsuitable for study treatment or study participation.
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：Complete Response Rate at 6 Months · Complete response rate at 6 months is defined as the proportion of participants who achieve complete response at 6 months after CAR-T cell infusion. · 6 months after CAR-T cell infusion
次要终点：Objective Response Rate；Complete Response Rate at Day 28；Complete Response Rate at 3 Months；Progression-Free Survival；Duration of Response；Overall Survival；Adverse Events
受试者接受瑞美吉泮联合格菲妥单抗和CD19 CAR-T细胞治疗。自淋巴细胞清除化疗首日起至CAR-T输注后第90天，瑞美吉泮口服75 mg、隔日一次。格菲妥单抗采用奥妥珠单抗预处理及递增给药，之后接受淋巴细胞清除化疗及CD19 CAR-T细胞治疗。CAR-T输注后达到CR、PR或疾病稳定（SD）的受试者可按方案继续格菲妥单抗巩固治疗。
受试者接受格菲妥单抗联合CD19 CAR-T细胞治疗。格菲妥单抗采用奥妥珠单抗预处理及递增给药，之后接受淋巴细胞清除化疗及CD19 CAR-T细胞治疗。CAR-T输注后达到CR、PR或疾病稳定（SD）的受试者可按方案继续格菲妥单抗巩固治疗。
本研究旨在评估瑞美吉泮联合格菲妥单抗和CD19 CAR-T细胞治疗高危复发/难治性大B细胞淋巴瘤患者的疗效和安全性。符合条件的患者将随机接受格菲妥单抗联合CD19 CAR-T治疗，方案中可加用或不加用瑞美吉泮。主要终点为CAR-T细胞输注后6个月的完全缓解率。
This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed/refractory large B-cell lymphoma. Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant. The primary endpoint is complete response rate at 6 months after CAR-T cell infusion.
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