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

Recruiting now · Not applicable

Conditions studied: BKV Infection, CMV Infection, EBV Infection

In brief

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.

Key facts

Study ID

NCT07685457

Run by

LucasBio

People needed

6

Starts

2026-02-10

Expected to finish

2027-05-20

Last updated by the study team

2026-07-06

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.).

You may not qualify if…

• 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.
• 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]
• 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.

Where it is running

• The Catholic University of Korea Seoul St.Mary's Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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