Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients W… (NCT07685457) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
South Korea6 participantsStarted 2026-02-10
Plain-language 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.
Who can participate
Age range
1 Year – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
. Patients who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit.
. Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration.
. Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Viral Load
Timeframe: From enrollment through 24 weeks after treatment initiation
2
Immunogenicity Testing
Timeframe: From enrollment through 24 weeks after treatment initiation.
3
Adverse Events
Timeframe: From the baseline visit through 24 weeks after treatment initiation.
. Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
. Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).
Exclusion criteria
. 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.
. Patients with organ failures and/or uncontrolled bacterial or fungal infections.
. Patients who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
. Patients with active graft-versus-host disease (GvHD) of grade 2 or higher.
. Patients with active malignant tumor or uncontrolled recurrence.
. Patients deemed ineligible for participation in this clinical study by the investigator.