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:Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
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、血液系统恶性肿瘤、实体瘤的安全性、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 · 奥罗拉、费城、孟菲斯、盐湖城(共 6 个中心)。登记号:NCT06579469。
不限性别 · ≤ 30 Years
纳入标准: • 首次接受全身给药 CAR-T 细胞输注后1–3个月内(±14天)。首次输注指首次接受此前未用过的 CAR-T 产品;或在异基因造血干细胞移植后再次接受既往用过的 CAR-T 产品。 • CAR-T 输注时年龄≤30岁。 排除标准: • 患有研究疾病以外的活动性恶性肿瘤。 • 计划在 CAR-T 输注后3个月内接受巩固性造血干细胞移植。 • CAR-T 输注后已接受或计划接受其他针对疾病的治疗。 • 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: * Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+/- 14 days). * Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT. * Age ≤ 30 years at CAR T cell infusion. Exclusion Criteria: * Active malignancy other than the disease under study. * Planned consolidative HSCT within 3 months post CAR T cell infusion. * Received or planned additional disease directed therapy post CAR T cell infusion. * 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:Presence of bone marrow dysfunction (BMD) · Among patients in remission or without bone marrow involvement of disease in the B-ALL cohort, we will summarize the rates of prevalent BMD at 3- and 6-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 3- and 6-months. · Within 6 months post CAR T-cell therapy;Occurrence of clinically significant infections · The infection density of clinically significant infections in 3-6 months will be summarized in the B-ALL cohort. · Within 6 months post CAR T-cell therapy;Presence of persistent ICANS · We will summarize the rates of persistent ICANS at 3- and 6-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 3- and 6-months in the B-ALL cohort. · Within 6 months post CAR T-cell therapy
次要终点:Presence of bone marrow dysfunction (BMD);Severity of BMD;Occurrence of clinically significant infections;Time to the earliest clinically significant infection;Severity of clinically significant infections;Presence of persistent ICANS;Severity of persistent ICANS
纳入过去1–3个月内首次接受 CAR-T 细胞治疗的 B-ALL 参加者。
纳入过去1–3个月内首次接受 CAR-T 细胞治疗的其他血液系统恶性肿瘤参加者。
纳入过去1–3个月内首次接受 CAR-T 细胞治疗的实体瘤参加者。
本研究旨在进一步了解 CAR-T 细胞治疗的短期和长期副作用,特别关注感染、血细胞计数恢复延迟和神经系统损伤的发生频率。
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
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