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

NCT07368634 | Recruiting Phase 1 DMC

• 1 other identifier: S2025-797
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epstein-Barr Virus Infection; Post-Transplant Lymphoproliferative Disorder

Keywords

EBV DNAemia; TCR-T Cell Therapy; Dose Escalation Study

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of EBV-TCR-T Cell Injection

  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 Outcomes (1)

• EBV DNA Clearance Rate

  Up to 3 months after the first EBV-TCR-T cell infusion

Study Arms (1)

EBV-TCR-T Cell Injection

EXPERIMENTAL

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

Interventions

EBV-TCR-T Cell Injection BIOLOGICAL

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.

EBV-TCR-T Cell Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daihong Liu: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Central Study Contacts

Daihong Liu

CONTACT

+8613681171597; daihongrm@163.com

Liping Dou

CONTACT

+8613681207138; lipingruirui@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 20, 2026
• First Posted: January 26, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)