Actively Recruiting
A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Daihong Liu · Updated on 2026-02-27
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a cell-based therapy using EBV-AST cell infusion for patients who develop EBV-DNA viremia after receiving allogeneic hematopoietic stem cell transplantation (Allo-HSCT). The study aims to identify the maximum tolerated dose or optimal biological dose of these cells and to assess their safety, tolerability, and preliminary effects in reducing EBV-DNA levels. This exploratory trial employs a 3+3 dose escalation design to study three different dosages of EBV-AST cells. Participants will receive one of three doses of EBV-AST cells: 3x10^5, 1x10^6, or 3x10^6 cells per kilogram of body weight. Each patient can receive up to three infusions, administered once a week. The study will monitor the safety of these infusions and evaluate their ability to lower EBV-DNA levels and maintain EBV-DNA negativity. Pharmacokinetics and pharmacodynamics of the cell therapy will also be assessed. During the study, participants will be regularly monitored for safety and response to treatment, including measuring EBV-DNA levels and T-cell frequency over 12 weeks following infusion. The primary outcome is the maximum tolerated dose determined within 28 days after each infusion. Secondary outcomes include the proportion of patients achieving EBV-DNA negativity, changes in viral load, time to negativity, and immune cell concentrations. The trial will follow participants from treatment through these assessments, with an expected study end date in 2028.
CONDITIONS
Brief Title
EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Have undergone allogeneic hematopoietic stem cell transplantation (Allo-HSCT)
- Have EBV-DNA viremia post-transplant with EBV-DNA > 1000 copies/mL on two consecutive tests or one test > 10,000 copies/mL
- Karnofsky Performance Score (KPS) of 70 or higher
- Expected survival of at least 3 months
- Sufficient organ function: renal function with serum creatinine ≤ 1.5 × upper limit of normal and creatinine clearance ≥ 50 mL/min; hepatic function with AST, ALT, and total bilirubin ≤ 5 × upper limit of normal; hematologic parameters with platelets ≥ 10 × 10^9/L and neutrophils ≥ 1.0 × 10^9/L
- HLA-matching criteria met for donor and recipient
You will not qualify if you...
- Active graft-versus-host disease (GVHD) Grade 2 or higher or requiring corticosteroids > 0.5 mg/kg/day for GVHD
- History of CMV viremia or disease within the past week
- Diagnosed or suspected post-transplant lymphoproliferative disorder (PTLD) within 1 week before infusion
- Severe active infections except EBV and CMV
- Serious allergic reactions or contraindications to the infusion
- Previous immune therapy-related adverse events of Grade 3 or higher
- History of HIV, HCV, or HBV infection with active viral load
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks
Participants receive up to three weekly infusions of EBV-AST cells to treat EBV-DNA viremia after stem cell transplantation.
Up to 3 weekly visits for infusions
Duration - Up to 12 weeks
Participants are monitored for safety and efficacy outcomes including EBV-DNA levels and immune response for up to 12 weeks after treatment.
Visits at multiple time points during 12 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
D
Daihong Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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