EBV-AST cell infusion for treating EBV-DNA viremia after allogeneic stem cell transplant.

A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation

This will test if infusions of EBV-targeted immune cells (EBV-AST) can lower EBV-DNA levels in adults who develop EBV viremia after an allogeneic stem cell transplant.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07438067 on ClinicalTrials.gov

What this trial studies

This phase 1/2 trial uses a 3+3 dose-escalation design to identify the maximum tolerated or optimal biological dose of EBV-AST cells given after allogeneic hematopoietic stem cell transplantation. Three dose levels (3×10^5, 1×10^6, and 3×10^6 cells/kg) will be evaluated, with each patient receiving up to three weekly infusions. Primary outcomes focus on safety and tolerability, while secondary measures include preliminary efficacy (reduction in EBV-DNA levels and duration of negativity) and PK/PD of the infused cells. Eligible patients are adults with post-transplant EBV-DNA viremia who meet HLA-matching and organ function criteria.

Who should consider this trial

Good fit: Adults aged 18–75 who underwent allogeneic HSCT, meet HLA-matching criteria, have EBV-DNA viremia (≥1,000 copies/mL on two tests or >10,000 on one), have KPS ≥70, adequate organ function, and an expected survival of at least three months are the intended participants.

Not a fit: Patients with active grade ≥2 GVHD or requiring >0.5 mg/kg/day corticosteroids, recent CMV viremia, suspected or confirmed PTLD within one week, severe active infection, or inadequate organ function are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, EBV-AST infusions could clear or reduce EBV viremia after transplant and lower the risk of progression to PTLD.

How similar studies have performed: Adoptive EBV-specific T-cell therapies have shown promise for treating post-transplant EBV-PTLD in prior studies, but this specific EBV-AST dose-escalation regimen is exploratory.

Eligibility criteria

Inclusion Criteria:

1. The patient must be aged 18-75 years.
2. ust have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT).
3. Must have EBV-DNA viremia post-transplant, with EBV-DNA \> 1000 copies/mL (on two consecutive tests or one test \> 10,000 copies/mL).
4. Karnofsky Performance Score (KPS) of 70 or higher.
5. Expected survival of at least 3 months.
6. 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).
7. HLA-matching criteria must be met for the donor/recipient.

Exclusion Criteria:

1. Active GVHD (Grade 2 or higher) or requiring \>0.5 mg/kg/day corticosteroids for GVHD.
2. History of CMV viremia or disease within the past week.
3. PTLD (Post-Transplant Lymphoproliferative Disorder) diagnosed or suspected within 1 week before infusion.
4. Severe active infections (excluding EBV and CMV).
5. Serious allergic reactions or contraindications to the infusion.
6. Previous immune therapy-related adverse events of Grade 3 or higher.
7. History of HIV, HCV, or HBV infection with an active viral load.

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Daihong Liu

Conditions EBV-DNA Viremia; Post-Transplant Lymphoproliferative Disorder; EBV-DNA viremia; Allogeneic Hematopoietic Stem Cell Transplantation; EBV-AST cell infusion