肿瘤细胞治疗研究
英文原题：Pragmatic Geriatric Assessment Before CAR-T or Bispecific Antibody Therapy to Predict Side Effects and Outcomes in Older Patients (GA-ACT Trial)
这是一项分期未标注的注册临床试验，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 208 例。试验地点：欧洲 · 伯尔尼、苏黎世（共 2 个中心）。登记号：NCT07309497。
不限性别 · ≥ 65 Years
纳入标准： • 男性或女性，年龄≥65岁。 • 计划接受 CAR-T 细胞或双特异性抗体（bsAb）治疗。 • 已签署知情同意书。 • 德语或法语能力足以完成研究。 排除标准： • 无法理解或签署知情同意书。 • 拒绝同意参加。
Inclusion Criteria: * male or female patients age ≥ 65 years, * scheduled for CAR-T-cell or bsAB treatments * signed informed consent * sufficient knowledge of the German or French language Exclusion Criteria: * inability to understand or sign informed consent * refuse to consent
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：treatment toxicity · primary endpoint will be the composite rate of death or any one of ≥ grade 3 toxicity · From enrollment to 3 month after end of treatment
次要终点：health related quality of life
CAR-T 细胞或双特异性抗体（bsAb）为侵袭性淋巴瘤或浆细胞疾病（如多发性骨髓瘤）患者提供了新的治疗选择，尤其适用于其他较低强度治疗无法治愈者。但这类强化治疗可能引起严重、甚至危及生命的副作用。虽然治疗没有年龄上限，但目前对老年患者的短期和长期副作用了解有限。关键研究中仅有少数患者年龄超过80岁，数量不足以评估65岁以上人群的耐受性和疗效。目前主要由主治医生判断患者是否适合治疗，尚无常规、客观的评估工具。本研究将采用简便的临床方法，评估老年人重要日常功能领域（活动能力、记忆、自理能力和营养），并判断能否预测严重和/或长期副作用风险。研究结果可能支持在治疗前将实用老年评估纳入标准流程，使风险和副作用更可预测，改善患者生活质量，并降低治疗及后续护理成本。
CAR-T cell or bispecific antibody therapies are a new treatment option for adult patients with aggressive forms of lymphoma or so-called plasma cell diseases ('multiple myeloma', 'plasma cell myeloma') that could not be cured with other, less intensive approaches. However, these are intensive therapies that can be associated with severe and potentially life-threatening side effects. Although there is no age limit for these therapies, we know little about the short- and long-term side effects of these treatments in people of advanced age. Although a small number of patients in the pivotal studies were even over 80 years old, their number was too small to be able to assess the tolerability and success specifically in people over 65. At present, the treating physicians decide whether and, if so, which patients are considered 'fit' enough for this therapy. An objective assessment of the kind we want to investigate in our study does not currently exist on a regular basis. In this study, we therefore want to use simple clinical methods to investigate the effects of these forms of therapy in different areas of everyday function that are important for people in older age (mobility, memory, self-care skills, nutrition). We want to find out whether these investigations help to predict the risk of severe and/or long-term side effects. Based on the results, a pragmatic geriatric assessment could be introduced as standard before these therapies. Older patients could thus expect an improvement in their quality of life thanks to more predictable risks and side effects. Standardized screening could lead to lower healthcare costs for treatment and aftercare for both forms of therapy.
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