A Phase 1 interventional study of EBV-AST cell in EBV-DNA Viremia, sponsored by Daihong Liu. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Daihong Liu · Phase 1, Interventional, and Treatment
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.
This clinical trial, initiated by the First Medical Center of the Chinese People's Liberation Army General Hospital, will recruit patients who have experienced EBV-DNA viremia following Allo-HSCT. Patients eligible for inclusion must exhibit EBV-DNA viremia that requires clinical intervention and should meet the inclusion criteria set for the study.
The research employs a 3+3 dose escalation methodology where three dosage groups are evaluated: 5×10\^5 cells/Kg, 1×10\^6 cells/Kg, and 5×10\^6 cells/Kg. Each patient will receive up to three infusions, one per week. The study will monitor both the safety and the preliminary efficacy of the infusions, including their ability to reduce EBV-DNA levels and the duration of EBV-DNA negativity. The trial will also assess the pharmacokinetics (PK) and pharmacodynamics (PD) of the EBV-AST cell infusion.
Daihong Liu is the lead sponsor of 13 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia in patients post-Allo-HSCT.
Biological: EBV-AST cell
EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia in patients post-Allo-HSCT.
Maximum Tolerated Dose (MTD) of EBV-AST Cell Infusion
The primary outcome measure of the study is to determine the maximum tolerated dose (MTD) of EBV-AST cell infusion in patients with EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). A dose-escalation design (5×10\^5, 1×10\^6, and 5×10\^6 cells/kg) will be used to evaluate safety and tolerability based on the occurrence of dose-limiting toxicities (DLTs).
Time frame: Day 1 through 28 days after each EBV-AST cell infusion during the dose escalation phase.
Proportion of Patients Achieving EBV-DNA Negativity
The proportion of patients achieving EBV-DNA negativity following EBV-AST cell infusion.
Time frame: 8 weeks and 12 weeks after EBV-AST cell infusion.
Change in EBV-DNA Levels
Change in EBV-DNA viral load from baseline following EBV-AST cell infusion.
Time frame: Baseline through 12 weeks after EBV-AST cell infusion.
Time to EBV-DNA Negativity
Time from EBV-AST cell infusion to first documented EBV-DNA negativity.
Time frame: Up to 12 weeks after EBV-AST cell infusion.
Absolute Concentration of Circulating EBV-AST Cells in Peripheral Blood at Pre-specified Time Points
Quantification of the absolute number of viable EBV-AST cells per microliter (μL) of peripheral blood using flow cytometry.
Time frame: Baseline through 28 days after EBV-AST cell infusion
Change in EBV-Specific T-Cell Frequency in Peripheral Blood
The fold change in the frequency of circulating EBV-specific T cells (LMP1/2-specific, EBNA1-specific) from baseline, as measured by flow cytometry or ELISpot.
Time frame: Baseline through 12 weeks after EBV-AST cell infusion.
Plan to share: No — Due to privacy concerns and the sensitive nature of the participant data, individual participant data (IPD) will not be shared. Access to data will be strictly controlled and provided only if required by regulatory authorities.
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Daihong Liu