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Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.

2026年6月29日 更新者：JaeWon Yoo、LucasBio

A Prospective Clinical Study to Evaluate the Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.

The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:

  • What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity?
  • What treatment emergent adverse events occur within 14 days after the second infusion?
  • Is there a clinically significant reduction in CMV, EBV, and BKV viral loads within 14 days following the second infusion?
  • Is there a clinically significant improvement in clinical symptoms within 14 days following the second infusion?

Participants will:

  • Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10^7/m^2; high dose: 2x10^7/m^2).
  • Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion.
  • Attend weekly follow-up visits at the clinic for 6 months after the first infusion.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

6

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Nayoun Kim, Ph.D.
  • 电话号码：+82 1040222340
  • 邮箱：nkim@lucasbio.com

学习地点

  • 韩国
      • Seoul、韩国、06591
        • 招聘中
        • The Catholic University of Korea Seoul ST.MARY'S Hospital
        • 首席研究员：
          • Jae-won Yoo, MD-PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Patients with CMV, EBV, and/or BKV infection that is resistant or refractory to standard-of-care treatment and associated with severe complications following allogeneic hematopoietic stem cell transplantation at the ages of 1-25 years.
  2. Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10^3/μL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.
  3. Patients who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit.
  4. Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration.
  5. Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
  6. Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
  7. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
  8. Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).

Exclusion Criteria:

  1. Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.

  2. Patients with organ failures and/or uncontrolled bacterial or fungal infections.

    • Moderate or severe liver damage [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN)]
    • Chronic kidney disease [eGFR < 30mL/min/1.73m^2]
  3. Patients who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
  4. Patients with active graft-versus-host disease (GvHD) of grade 2 or higher.
  5. Patients with active malignant tumor or uncontrolled recurrence.
  6. Patients deemed ineligible for participation in this clinical study by the investigator.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental Group (All, ped)
生物：LB-DTK-MV
LB-DTK-MV is a virus-specific T cell therapy product derived from a designated donor and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration. Study participants will receive a single intravenous infusion of the assigned cell dose (low dose: 1x10^7/m^2;high dose: 2x10^7/m^2) of LB-DTK-MV on Visit 2 and 14 days after the initial infusion.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Viral Load
大体时间：From enrollment through 24 weeks after treatment initiation
CMV, EBV, and BKV viral load testing is performed using RT-PCR on blood, urine, and/or tissue samples. Viral load is measured weekly for the first 4 weeks, followed by two measurements at 2-week intervals to monitor the progression of the infection, then once every 4 weeks, and subsequently once every 12 weeks.
From enrollment through 24 weeks after treatment initiation
Immunogenicity Testing
大体时间：From enrollment through 24 weeks after treatment initiation.
Immunogenicity testing using the ELISpot assay is performed weekly for the first 4 weeks following administration of the investigational drug. Thereafter, to evaluate the persistence and reconstitution of the immune response, measurements are taken twice at 2-week intervals, once at 4-week intervals, and once at 12-week intervals. Flow cytometry will be performed concurrently at each time point to evaluate cytokine profiles and immune cell subsets.
From enrollment through 24 weeks after treatment initiation.
Adverse Events
大体时间：From the baseline visit through 24 weeks after treatment initiation.
The investigator must confirm the occurrence of adverse events through medical examinations during regular visits throughout the clinical study period. Adverse events shall be assessed at each visit starting from the administration of the investigational drug at the baseline visit (Visit 2).
From the baseline visit through 24 weeks after treatment initiation.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

LucasBio

调查人员

  • 首席研究员：Jae-won Yoo, MD-PhD、Department of Pediatrics, The Catholic University of Korea Seoul St.Mary's Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月10日

初级完成 (估计的)

2027年5月20日

研究完成 (估计的)

2027年5月20日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LB-DD-DTK-MV-HS-PD-CR

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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