EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation

NCT07438067 | Recruiting Phase 1 DMC

• 1 other identifier: S2025-241
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

EBV-DNA Viremia; Post-Transplant Lymphoproliferative Disorder

Keywords

EBV-DNA viremia; Allogeneic Hematopoietic Stem Cell Transplantation; EBV-AST cell infusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of Patients Achieving EBV-DNA Negativity

  8 weeks and 12 weeks after EBV-AST cell infusion.

• Change in EBV-DNA Levels

  Baseline through 12 weeks after EBV-AST cell infusion.

• Time to 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

  Baseline through 28 days after EBV-AST cell infusion

• Change in EBV-Specific T-Cell Frequency in Peripheral Blood

  Baseline through 12 weeks after EBV-AST cell infusion.

Study Arms (1)

EBV-AST cell infusion

EXPERIMENTAL

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

Interventions

EBV-AST cell BIOLOGICAL

EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia and prevention of PTLD in patients post-Allo-HSCT.

EBV-AST cell infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daihong Liu: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

Central Study Contacts

Daihong Liu

CONTACT

+8613681171597; daihongrm@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Hematology

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 27, 2026
• Study Start: March 26, 2025
• Primary Completion (Estimated): March 26, 2028
• Study Completion (Estimated): March 26, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)