drugset / Trial / NCT07438067

EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation

NCT07438067 ↗

Phase 1/2 Recruiting 18 enrolled Daihong Liu
NaSingle-groupOpen-labelTreatment

Summary

This exploratory clinical study focuses on the use of EBV-AST cell infusion for treating EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). The study aims to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of EBV-AST cells and assess their safety, tolerability, and preliminary efficacy in treating EBV-DNA viremia. The study will involve a 3+3 dose escalation design to evaluate three different dosages of EBV-AST cell infusion. The study is expected to provide important insights into the clinical application of cell-based therapies for EBV infections.

Timeline

Start
2025-03-26
Primary completion
2028-03-26
Completion
2028-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject EBV-AST cell Cell therapy 300000 cells/kg —
Subject EBV-AST cell Cell therapy 1e+06 cells/kg —
Subject EBV-AST cell Cell therapy 3e+06 cells/kg —