Actively Recruiting
Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Daihong Liu · Updated on 2026-01-28
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who have Epstein-Barr virus (EBV) DNAemia after receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). This condition can lead to serious complications like EBV-associated lymphoproliferative disorders. The study aims to explore the safety, tolerability, and early effects of a new immune-based therapy using EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cells) to target and eliminate EBV-infected cells. Participants will receive intravenous infusions of EBV-TCR-T cells, which are genetically engineered T lymphocytes designed to recognize EBV antigens. The treatment involves up to three weekly infusions on Day 0, Day 7, and Day 14, with dose levels increasing from 1×10^5 to 1×10^6 cells/kg. The study will follow a dose-escalation design to determine the maximum tolerated dose and optimal biologic dose. During the study, participants will be monitored for safety and immune response for up to 12 months after the first infusion. Researchers will assess adverse events, the clearance of EBV DNA, changes in viral load, and how the infused cells expand and persist in the body. These evaluations include pharmacokinetic and pharmacodynamic analyses, with long-term safety follow-up as specified in the protocol.
CONDITIONS
Brief Title
Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of enrollment
- History of allogeneic hematopoietic stem cell transplantation
- Presence of Epstein-Barr virus (EBV) DNAemia confirmed by quantitative PCR in blood
- EBV DNAemia persisting or increasing despite standard management
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function as defined by the study protocol
- Ability to understand and sign written informed consent
You will not qualify if you...
- Diagnosis of EBV-associated lymphoproliferative disorder needing immediate chemotherapy
- Active, uncontrolled infection other than EBV
- History of severe autoimmune disease requiring systemic immunosuppressive therapy
- Uncontrolled graft-versus-host disease requiring high-dose corticosteroids or immunosuppressants
- 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 participation
- Pregnant or breastfeeding women
- Any medical, psychological, or social condition that would interfere with safe participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks, with infusions on Day 0, Day 7, and Day 14 depending on safety and virologic response.
Participants receive EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) by intravenous infusion to target and eliminate EBV-infected cells.
Up to 3 weekly infusions
Duration - Up to 12 months after the first infusion
Participants are followed for safety, efficacy, and immune response after the last infusion.
Regular follow-up visits as per protocol
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
D
Daihong Liu
L
Liping Dou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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