Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation

January 26, 2026 updated by: Daihong Liu

An Exploratory Clinical Study of EBV-TCR-T Cell Injection for the Treatment of EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation

Epstein-Barr virus (EBV) DNAemia is a common and potentially serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and may progress to EBV-associated lymphoproliferative disorders. Current treatment options are limited, and effective immune-based therapies are still needed.

This is an investigator-initiated, exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) in patients with EBV DNAemia after allo-HSCT. Eligible participants will receive intravenous infusions of EBV-TCR-T cells at escalating dose levels. Safety outcomes, EBV-DNA clearance, and preliminary efficacy will be assessed, along with pharmacokinetic and pharmacodynamic characteristics of the infused cells.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an investigator-initiated, exploratory, open-label, single-arm, dose-escalation clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of EBV-specific T cell receptor-engineered T cell injection (EBV-TCR-T) in patients with EBV DNAemia following allogeneic hematopoietic stem cell transplantation.

EBV-TCR-T cells are genetically engineered T lymphocytes expressing EBV antigen-specific T cell receptors, enabling targeted recognition and elimination of EBV-infected cells. In this study, peripheral blood mononuclear cells will be collected from the patient or an appropriate donor and used to manufacture EBV-TCR-T cells, which will be administered by intravenous infusion.

The study will enroll approximately 4 to 18 participants. Three dose levels are planned: 1×10^5 cells/kg, 5×10^5 cells/kg, and 1×10^6 cells/kg per infusion. Participants will receive weekly infusions, with up to three infusions administered at Day 0, Day 7, and Day 14, depending on safety and virologic response. Dose escalation will follow a predefined dose-limiting toxicity (DLT)-based design to determine the maximum tolerated dose and the potential optimal biologic dose.

The primary objectives of the study are to evaluate safety and tolerability, including the incidence and severity of adverse events, immune-related adverse events, serious adverse events, and dose-limiting toxicities. Secondary objectives include assessment of preliminary efficacy, such as EBV-DNA clearance rate, time to EBV-DNA negativity, and changes in EBV viral load. Pharmacokinetic and pharmacodynamic analyses will assess in vivo expansion, persistence of EBV-TCR-T cells, and associated immune biomarkers.

Participants will be followed for safety, efficacy, and immune response for up to 12 months after the first infusion, with long-term safety follow-up conducted according to protocol requirements.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Chinese PLA General Hospital
          • Phone Number: 86-10-66937166
          • Email: 301irb@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years at the time of enrollment.
  • History of allogeneic hematopoietic stem cell transplantation.
  • Presence of Epstein-Barr virus (EBV) DNAemia confirmed by quantitative polymerase chain reaction (qPCR) in peripheral blood.
  • EBV DNAemia persisting or increasing despite standard management, as determined by the investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Adequate organ function as defined by the study protocol.
  • Ability to understand and willingness to sign written informed consent.

Exclusion Criteria:

  • Diagnosis of EBV-associated lymphoproliferative disorder requiring immediate cytotoxic chemotherapy.
  • Active, uncontrolled infection other than EBV.
  • History of severe autoimmune disease requiring systemic immunosuppressive therapy.
  • Uncontrolled graft-versus-host disease requiring high-dose systemic corticosteroids or other immunosuppressive treatment.
  • Prior treatment with EBV-specific adoptive T cell therapy within a defined washout period.
  • Known active malignancy other than EBV-related disease that may interfere with study participation.
  • Pregnant or breastfeeding women.
  • Any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with safe participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBV-TCR-T Cell Injection

Participants enrolled in this arm will receive EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) administered by intravenous infusion. EBV-TCR-T cells are genetically modified T lymphocytes designed to recognize and eliminate Epstein-Barr virus-infected cells.

Participants will receive EBV-TCR-T cell infusions at predefined dose levels according to the study protocol. Infusions are administered weekly, with up to three infusions given on Day 0, Day 7, and Day 14, depending on safety and virologic response. Safety, tolerability, and preliminary efficacy will be evaluated throughout the study.
Biological: EBV-TCR-T Cell Injection

EBV-TCR-T cell injection consists of Epstein-Barr virus-specific T cell receptor-engineered T lymphocytes manufactured from peripheral blood mononuclear cells. These cells are genetically modified to express EBV antigen-specific T cell receptors, enabling targeted recognition and elimination of EBV-infected cells.

The EBV-TCR-T cells are administered by intravenous infusion at predefined dose levels according to the study protocol, with up to three infusions given at weekly intervals. This intervention is intended to evaluate the safety, tolerability, and preliminary efficacy of EBV-TCR-T cells in patients with EBV DNAemia following allogeneic hematopoietic stem cell transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of EBV-TCR-T Cell Injection
Time Frame: From the first infusion up to 28 days after the last EBV-TCR-T cell infusion
Safety and tolerability will be assessed by the incidence, nature, and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) following EBV-TCR-T cell infusion. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Immune-related adverse events, including cytokine release syndrome and other infusion-related reactions, will be closely monitored throughout the study.
From the first infusion up to 28 days after the last EBV-TCR-T cell infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EBV DNA Clearance Rate
Time Frame: Up to 3 months after the first EBV-TCR-T cell infusion
EBV DNA clearance rate is defined as the proportion of participants who achieve EBV DNA negativity in peripheral blood following EBV-TCR-T cell infusion, as measured by quantitative polymerase chain reaction (qPCR).
Up to 3 months after the first EBV-TCR-T cell infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daihong Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2025-797

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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