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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.

StatusRecruiting
PhaseNot applicable
SponsorLucasBio
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
7 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07685457
Lead Sponsor LucasBio
Conditions
(from sponsor)
BKV Infection, CMV Infection, EBV Infection
Related terms Cytomegalovirus Infections, Epstein-Barr Virus Infections, Infections
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov