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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Transplant Lymphoproliferative Disorder; EBV-DNA Viremia
• Intervention / Treatment: Biological: EBV-AST cell

Detailed Description

This clinical trial, initiated by the First Medical Center of the Chinese People's Liberation Army General Hospital, will recruit patients who have experienced EBV-DNA viremia following Allo-HSCT. Patients eligible for inclusion must exhibit EBV-DNA viremia that requires clinical intervention and should meet the inclusion criteria set for the study.

The research employs a 3+3 dose escalation methodology where three dosage groups are evaluated: 3×10^5 cells/Kg, 1×10^6 cells/Kg, and 3×10^6 cells/Kg. Each patient will receive up to three infusions, one per week. The study will monitor both the safety and the preliminary efficacy of the infusions, including their ability to reduce EBV-DNA levels and the duration of EBV-DNA negativity. The trial will also assess the pharmacokinetics (PK) and pharmacodynamics (PD) of the EBV-AST cell infusion.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Daihong Liu; Phone Number: +8613681171597; Email: daihongrm@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hospital
    • Contact: Daihong Liu; Phone Number: +8613681171597; Email: daihongrm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EBV-AST cell infusion; EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia and prevention of PTLD in patients post-Allo-HSCT.	Biological: EBV-AST cell; EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia and prevention of PTLD in patients post-Allo-HSCT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose (MTD) of EBV-AST Cell Infusion	The primary outcome measure of the study is to determine the maximum tolerated dose (MTD) of EBV-AST cell infusion in patients with EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). A dose-escalation design (3×10^5, 1×10^6, and 3×10^6 cells/kg) will be used to evaluate safety and tolerability based on the occurrence of dose-limiting toxicities (DLTs).	Day 1 through 28 days after each EBV-AST cell infusion during the dose escalation phase.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Achieving EBV-DNA Negativity	The proportion of patients achieving EBV-DNA negativity following EBV-AST cell infusion.	8 weeks and 12 weeks after EBV-AST cell infusion.
Change in EBV-DNA Levels	Change in EBV-DNA viral load from baseline following EBV-AST cell infusion.	Baseline through 12 weeks after EBV-AST cell infusion.
Time to EBV-DNA Negativity	Time from EBV-AST cell infusion to first documented EBV-DNA negativity.	Up to 12 weeks after EBV-AST cell infusion.
Absolute Concentration of Circulating EBV-AST Cells in Peripheral Blood at Pre-specified Time Points	Quantification of the absolute number of viable EBV-AST cells per microliter (μL) of peripheral blood using flow cytometry.	Baseline through 28 days after EBV-AST cell infusion
Change in EBV-Specific T-Cell Frequency in Peripheral Blood	The fold change in the frequency of circulating EBV-specific T cells (LMP1/2-specific, EBNA1-specific) from baseline, as measured by flow cytometry or ELISpot.	Baseline through 12 weeks after EBV-AST cell infusion.

Collaborators and Investigators

• Sponsor: Daihong Liu

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): March 26, 2028
• Study Completion (Estimated): March 26, 2028

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Allogeneic Hematopoietic Stem Cell Transplantation; EBV-DNA viremia; EBV-AST cell infusion
• Other Study ID Numbers: S2025-241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to privacy concerns and the sensitive nature of the participant data, individual participant data (IPD) will not be shared. Access to data will be strictly controlled and provided only if required by regulatory authorities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No