← 返回临床试验

儿童 CAR-T 细胞治疗迟发效应的前瞻性评估

英文原题:Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy

查看英文原题

Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy

ClinicalTrials.gov 2024/08/30(首次登记) 注册临床试验(分期未标注) · 招募中

简要介绍

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。

入组条件决定能不能参加

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。
核对登记原文(英文)
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。

研究终点衡量什么算有效

  • 主要终点骨髓功能障碍(BMD)的发生情况CAR-T 治疗后6个月内。
  • 主要终点临床显著感染的发生情况CAR-T 治疗后6个月内。
  • 主要终点持续性 ICANS 的发生情况CAR-T 治疗后6个月内。
  • 次要终点骨髓功能障碍(BMD)的发生情况
  • 次要终点BMD 的严重程度
  • 次要终点临床显著感染的发生情况
  • 次要终点首次临床显著感染的时间
  • 次要终点临床显著感染的严重程度
  • 次要终点持续性 ICANS 的发生情况
  • 次要终点持续性 ICANS 的严重程度
核对登记原文(英文)

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

研究设计怎么做的

研究类型
观察性研究
入组人数
100 人(预计)
  • B 细胞急性淋巴细胞白血病(B-ALL)队列

    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。

  • 其他血液系统恶性肿瘤

    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。

  • 实体瘤队列

    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。

核对分组登记原文(英文)
  • B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohort · B-ALL participants who have received initial CAR T cell therapy within the last 1-3 months.
  • Other hematologic malignancy · Other hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months.
  • Solid tumor (ST) · ST participants who have received initial CAR T cell therapy within the last 1-3 months.

关键日期

开始日期
2026-01-20
主要完成日期
2027-03
全部完成日期
2029-03
登记状态核实于
2026-06

联系与责任方

申办方
St. Jude Children's Research Hospital
合作方
Rally Foundation for Childhood Cancer Research
联系邮箱
referralinfo@stjude.org
联系电话
888-226-4343

登记简述

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。

核对登记原文(英文)

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.

登记原文与核验信息

试验登记号
NCT06579469
试验状态
招募中
试验中心
Childrens Hospital of Colorado · 奥罗拉 · 美国 | Children's Hospital of Philadelphia · 费城 · 美国 | St. Jude Children's Research Hospital · 孟菲斯 · 美国 | Primary Children's Hospital · 盐湖城 · 美国 | Seattle Childrens Hospital · 西雅图 · 美国 | Children's Hospital of Wisconsin. · 密尔沃基 · 美国
适应症(原文)
B-ALL; Hematologic Malignancy; Solid Tumor