Epstein-Barr Virus InfectionPhase 1/2NCT07368634
Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 1/2 study testing EBV-TCR-T Cell Injection in people with Epstein-Barr Virus Infection and Post-Transplant Lymphoproliferative Disorder, run by Daihong Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epstein-Barr Virus Infection, Post-Transplant Lymphoproliferative Disorder
- What is being tested?
- EBV-TCR-T Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Chinese PLA General Hospital, 86-10-66937166, 301irb@sina.com
About this study
Official title: 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.
Read the 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.
- Being tested
- EBV-TCR-T Cell Injection
- Keywords
- EBV DNAemia, TCR-T Cell Therapy, Dose Escalation Study
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV-TCR-T Cell InjectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: EBV-TCR-T Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first infusion up to 28 days after the last EBV-TCR-T cell infusion
Secondary outcomes (1)
EBV DNA Clearance Rate
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).
Measured: Up to 3 months after the first EBV-TCR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daihong Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daihong Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368634
- Sponsor's protocol ID
- S2025-797
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of EBV-TCR-T Cell Injection for the Treatment of EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07368634
- Acronym / sponsor ID
- S2025-797
- Keywords
- EBV DNAemia, TCR-T Cell Therapy, Dose Escalation Study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Daihong LiuUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBV-TCR-T Cell Injection | Experimental | Biological: EBV-TCR-T Cell InjectionParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBV-TCR-T Cell InjectionEBV-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. | Biological | EBV-TCR-T Cell Injection |
Primary outcome
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.
1 secondary outcome
EBV DNA Clearance Rate
Time frame: Up to 3 months after the first EBV-TCR-T cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EBV-TCR-T Cell Injection in people with Epstein-Barr Virus Infection and Post-Transplant Lymphoproliferative Disorder, run by Daihong Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daihong Liu (+8613681171597, daihongrm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.