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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Viral Load — 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.
• Immunogenicity Testing — 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.
• Adverse Events — 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).

Trial sites (1)

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