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:Long-term Follow-up Study of Patients Receiving CAR-T Cells
Long-term Follow-up Study of Patients Receiving CAR-T Cells
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 CAR-T 细胞治疗慢性淋巴细胞白血病、淋巴瘤、套细胞淋巴瘤的安全性、可行性及初步疗效。当前状态:招募中。计划入组 500 例。试验地点:美国 · 密尔沃基(共 1 个中心)。登记号:NCT03375619。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
纳入标准: • 曾在Froedtert医院及威斯康星医学院参加CAR-T 研究的所有受试者。 排除标准: • 本研究无排除标准。
Inclusion Criteria: * All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin. Exclusion Criteria: * There are no exclusion criteria for this study.
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:Change from baseline in the incidence of a new malignancy at 5 years. · The number of subjects with new malignancy. · Baseline to five years.;Change from baseline in the incidence of a new malignancy at 10 years. · The number of subjects with new malignancy. · Baseline to 10 years.;Change from baseline in the incidence of a new malignancy at 15 years. · The number of subjects with new malignancy. · Baseline to 15 years.
曾在Froedtert医院及威斯康星医学院相关临床试验中接受CAR-T 细胞的受试者(如NCT05976555、NCT05094206、NCT05990465、NCT03019055或NCT04186520)。
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。
本方案是一项长期随访研究,纳入在威斯康星医学院/Froedtert医院临床试验中接受CAR-T 细胞治疗的受试者。相关临床试验包括:复发/难治性B细胞恶性肿瘤患者CAR-20/19-T细胞I期研究(NCT03019055);复发/难治性骨髓瘤患者BCMA-TGF-BETA CAR-T 细胞I期试验(NCT05976555);复发/难治性B细胞恶性肿瘤患者CAR20.19.22 T细胞研究(NCT05094206);吡托布鲁替尼联合LV20.19 CAR-T 细胞治疗复发/难治性B细胞恶性肿瘤研究(NCT05990465);以及复发/难治性B细胞恶性肿瘤患者CAR-20/19-T细胞研究(NCT04186520)。
This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following: Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)
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