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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.

NCT07685457 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-07-06

No results posted yet for this study

Summary

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.

Conditions

  • BKV Infection
  • CMV Infection
  • EBV Infection

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • LucasBio

    lead INDUSTRY

Principal Investigators

  • Jae-won Yoo, MD-PhD · Department of Pediatrics, The Catholic University of Korea Seoul St.Mary's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2027-05-20
Completion
2027-05-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07685457 on ClinicalTrials.gov