CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Outcomes After Chimeric Antigen Receptor Therapy and Radiation Therapy for Hematologic Malignancies
Outcomes After Chimeric Antigen Receptor Therapy and Radiation Therapy for Hematologic Malignancies
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项分期未标注的注册临床试验,评估细胞治疗用于肿瘤的安全性、可行性及初步疗效。当前状态:招募中。计划入组 100 例。试验地点:美国 · 休斯顿(共 1 个中心)。登记号:NCT04888338。
不限性别 · ≥ 18 Years
纳入标准: • 年龄≥18岁。 • 在90天时间窗内,因血液系统恶性肿瘤接受或计划接受放射治疗、标准治疗CAR-T 细胞治疗和/或标准治疗双特异性抗体治疗。
Inclusion Criteria: * Age 18 years or older * Treatment with or intention to treat with radiation therapy, standard-of-care CAR-T cell therapy and/or standard-of-care bispecific therapy, within a 90 day window for a hematologic malignancy
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:Clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT) · Outcome measures will include the following: date and type of disease progression, time to lymphoma progression, progression confirmed on biopsy (yes/no), disease control within the radiation field, survival and date of death, cause of death, overall response rate/best response achieved, duration of response, Toxicities including adverse events (CTCAE v 5.0), Neurotoxicity (ICANS) and cytokine release syndrome grade · Up to 5 years
次要终点:Patient-specific factors and treatment-related factors;Relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes;Relationship between patient-specific factors and treatment-related factors and treatment toxicity
审阅患者病历,收集CAR-T 和放疗(RT)治疗详情、急性和晚期毒性、疾病结局(如局部或远处进展相关事件)、生存情况及可获得的死因信息。收集基线影像,并在首次RT或CAR-T 治疗后2个月内、第3、6、12个月及此后每年收集影像资料,最长5年。
以上邮箱 / 电话是登记库里的申办方联系方式(号码归属待核实),通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
本研究收集血液系统恶性肿瘤患者接受嵌合抗原受体疗法和放射治疗后的结局信息。在患者接受CAR-T 或放射治疗前、治疗期间和治疗后收集信息,有助于医生优化患者选择、剂量、治疗时机及治疗顺序。
This study collects information on outcomes after chimeric antigen receptor therapy and radiation therapy for hematologic malignancies. Collecting information from patients before, during, and after receiving chimeric antigen receptor therapy or radiation therapy may help doctors to optimize patient selection, dose, timing, and sequencing of these treatments.
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