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Recruiting NCT07438067

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

Phase I Interventional EBV-DNA Viremia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EBV-AST cell.
Who it may be relevant to
Registry conditions: EBV-DNA Viremia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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: 5×10\^5 cells/Kg, 1×10\^6 cells/Kg, and 5×10\^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.

Interventions

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

Primary outcome measures

  • Maximum Tolerated Dose (MTD) of EBV-AST Cell Infusion [Time frame: Day 1 through 28 days after each EBV-AST cell infusion during the dose escalation phase.]
Secondary outcome measures (5)
  • Proportion of Patients Achieving EBV-DNA Negativity [Time frame: 8 weeks and 12 weeks after EBV-AST cell infusion.]
  • Change in EBV-DNA Levels [Time frame: Baseline through 12 weeks after EBV-AST cell infusion.]
  • Time to EBV-DNA Negativity [Time frame: Up to 12 weeks after EBV-AST cell infusion.]
  • Absolute Concentration of Circulating EBV-AST Cells in Peripheral Blood at Pre-specified Time Points [Time frame: Baseline through 28 days after EBV-AST cell infusion]
  • Change in EBV-Specific T-Cell Frequency in Peripheral Blood [Time frame: Baseline through 12 weeks after EBV-AST cell infusion.]

Eligibility criteria

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07438067 · S2025-241

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗