EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation (NCT07438067) | Clinical Trial Compass
RecruitingPhase 1/2
EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation
China18 participantsStarted 2025-03-26
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Maximum Tolerated Dose (MTD) of EBV-AST Cell Infusion
Timeframe: Day 1 through 28 days after each EBV-AST cell infusion during the dose escalation phase.