EBV-AST cell infusion for treating EBV-DNA viremia after allogeneic stem cell transplant.
Official title: A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation
Run by Chinese PLA General Hospital · NCT07438067 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | March 26, 2025 |
| Main results expected | March 26, 2028 |
| Study ends | March 26, 2028 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT07438067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Chinese PLA General Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Daihong Liu
- Email: daihongrm@163.com
- Phone: +8613681171597
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.