决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
我们评估了11例接受单一批次cemacabtagene ansegedleucel(cema-cel)治疗的大B细胞淋巴瘤患者,cemacabtagene ansegedleucel是一种异体抗CD19 CAR T产品。
英文原题:CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
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这是一项分期未标注的注册临床试验,评估细胞治疗用于急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态:招募中。计划入组 80 例。试验地点:美国 · 孟菲斯(共 1 个中心)。登记号:NCT07048535。
不限性别
纳入标准: • 首次 CAR 治疗时年龄≤26岁。 • 因 B-ALL 接受过含 CD19 的 CAR-T 产品(研究性或已上市产品)。 • 仅接受过一种 CAR 产品(允许同一产品再次输注)。 • CAR 治疗后持续缓解,且未接受后续治疗(CAR-T 后巩固性造血干细胞移植除外)。 • 既往仅接受过一次造血干细胞移植(可在 CAR-T 前或后)。 • 距末次 CAR-T 输注至少2年。 排除标准: • 研究参加者或其法定监护人/代表无法或不愿提供书面知情同意。
Inclusion Criteria: * ≤ 26-years old at the time of the first CAR treatment * Receipt of a CD19-containing CAR T-cell product (investigational or commercial) for B- ALL * Receipt of one unique CAR product (reinfusion of same product allowed) * Sustained remission without subsequent therapy post-CAR (exception= post-CAR consolidative HCT) * Receipt of only one prior HCT (inclusive of pre- or post-CAR) * ≥ 2-years post last CAR T-cell infusion Exclusion Criteria: * Inability or unwillingness of research participant or legal guardian/representative to give written informed 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:To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy · Estimation of participation rate · Through study completion, approximately 5 years
以上邮箱 / 电话是登记库里的申办方联系方式,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。
本研究旨在了解接受 CD19 靶向嵌合抗原受体(CAR)T 细胞治疗的 B 细胞急性淋巴细胞白血病(B-ALL)患者长期健康状况。 主要目标:利用 St Jude Lifetime Cohort(SJLIFE)的临床及研究基础设施,评估在多家机构治疗的儿童、青少年及年轻成人(AYA)B-ALL 幸存者接受 CD19 CAR-T 治疗后,开展标准化临床评估的可行性。 探索性目标:描述儿童及 AYA B-ALL 幸存者接受 CD19 CAR-T 治疗≥2年后持续存在或新发/迟发健康问题的患病率;评估其神经认知和神经系统功能、免疫健康及功能状态。
To learn more about the long-term health in patients treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Cluster of Differentiation antigen 19 (CD19) -redirected chimeric antigen receptor (CAR) T-cells. Primary Objective: To evaluate the feasibility of conducting standardized clinical assessments of pediatric, adolescent and young adult (AYA) B-ALL survivors post CD19-CAR T-cell therapy, treated at multiple institutions, leveraging the St Jude Lifetime Cohort (SJLIFE) clinical and research infrastructure. Exploratory Objectives: * To describe the prevalence of persistent and new/late-onset health conditions developing ≥2-years post CD19-CAR T-cell therapy in survivors of pediatric and AYA B-ALL. * To characterize neurocognitive and neurologic function in survivors ≥2-years post CD19- CAR T-cell therapy. * To characterize immune health in survivors ≥2-years post CD19-CAR T-cell therapy. * To characterize functional status in survivors ≥2-years post CD19-CAR T-cell therapy.
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