肿瘤细胞治疗研究
英文原题：Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment
这是一项分期未标注的注册临床试验，评估细胞治疗用于慢性淋巴细胞白血病、弥漫大 B 细胞淋巴瘤、滤泡性淋巴瘤的安全性、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：美国 · 波特兰（共 1 个中心）。登记号：NCT06784167。
不限性别 · ≥ 18 Years
纳入标准： * * 愿意在进行任何研究特定程序或活动之前提供书面知情同意 * 签署知情同意书时年龄 ≥ 18 岁 * 经组织学或细胞学确诊的多发性骨髓瘤（MM）、弥漫性大 B 细胞淋巴瘤（DLBCL）、滤泡性淋巴瘤（FL）、套细胞淋巴瘤（MCL）、慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL），或原发性纵隔 B 细胞淋巴瘤（PMBL）。允许既往任何线数的治疗 * 有既往针对常见 VPD 的疫苗接种史 * 经主治医师批准接受 CAR-T 治疗，并计划在未来 90 天内进行预处理 * 经主治医师批准针对肺炎链球菌或破伤风进行再接种 排除标准： * * 正在使用免疫抑制剂或计划进行会干扰研究终点解读的免疫抑制治疗 * 未控制的、并发疾病，包括但不限于全身性感染、症状性充血性心力衰竭、不稳定型心绞痛，或会限制研究要求依从性或使研究程序不宜进行的精神疾病/社会状况
Inclusion Criteria: * \* Willingness to provide written informed consent before any study-specific procedures or activities are performed * Age ≥ 18 years of age, at the time of consent * Documented, histologically or cytologically confirmed diagnosis of multiple myeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). All number of prior lines of therapy are allowed * History of prior vaccination against common VPD * Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days * Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus Exclusion Criteria: * \* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints * Uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or make the study procedures unadvisable
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：Preserved immunity · Will be defined as titers that meet the definition of positive both pre- and post-CAR-T cell infusion. The proportion of subjects who have preserved immunity to each VPD will be estimated with an exact 95% confidence interval. · Up to 12 months after CAR-T cell infusion
次要终点：Change in antibody titers
根据机构的再接种政策，患者最多可接种3剂肺炎球菌和/或破伤风疫苗。患者在整个研究期间接受血液样本采集并接受病历审查。
本研究评估CAR-T治疗后的免疫反应，以查明CAR-T治疗是否降低多发性骨髓瘤和非霍奇金淋巴瘤患者对麻疹、腮腺炎和风疹等疾病疫苗（疫苗免疫）的有效性。
This study evaluates immune responses after CAR-T therapy to find out if CAR-T therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-Hodgkin lymphoma.
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