EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation
A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation
Daihong Liu
18 participants
Mar 26, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- The patient must be aged 18-75 years.
- ust have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT).
- Must 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, including renal (serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min), hepatic (AST, ALT, and total bilirubin ≤ 5 × ULN), and hematologic parameters (platelets ≥ 10 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L).
- HLA-matching criteria must be met for the donor/recipient.
Exclusion Criteria7
- Active GVHD (Grade 2 or higher) or requiring \>0.5 mg/kg/day corticosteroids for GVHD.
- History of CMV viremia or disease within the past week.
- PTLD (Post-Transplant Lymphoproliferative Disorder) diagnosed or suspected within 1 week before infusion.
- Severe active infections (excluding 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 an active viral load.
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Interventions
EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia and prevention of PTLD in patients post-Allo-HSCT.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07438067