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:A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies
这是一项分期未标注的注册临床试验,评估细胞治疗用于血液系统恶性肿瘤的安全性、可行性及初步疗效。当前状态:邀请入组。计划入组 70 例。试验地点:美国 · 杜阿尔特、洛杉矶、斯坦福、纽黑文(共 24 个中心)。登记号:NCT06208878。
不限性别 · ≥ 18 Years
纳入标准: * 能够理解并遵守方案要求的研究程序,并自愿签署和注明日期的书面知情同意书。 * 必须接受过CRISPR CAR T细胞治疗。 排除标准: * 无特定排除标准。
Inclusion Criteria: * Able to understand and comply with protocol-required study procedures and voluntarily sign and date a written informed consent document. * Must have received CRISPR CAR T cellular therapy. Exclusion Criteria: * There are no specific exclusion criteria.
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:The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment. · The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized. · 15 years
次要终点:The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment
所有在母研究中入组并接受过异体CRISPR CAR T细胞治疗的血流系统恶性肿瘤和实体瘤受试者,将被邀请参加这项长期随访(LTFU)研究。
本研究将评估CRISPR CAR T细胞疗法的长期安全性和有效性。
This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies
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