EBV-DNA ViremiaPhase 1NCT07438067
EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation
A Phase 1 study testing EBV-AST cell in people with EBV-DNA Viremia, run by Daihong Liu at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- EBV-DNA Viremia
- What is being tested?
- EBV-AST cell
- 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
- 26 Mar 2025to 26 Mar 2028
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
Daihong Liu, +8613681171597, daihongrm@163.com
About this study
Official title: A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Conditions
- EBV-DNA Viremia
- Being tested
- EBV-AST cell
- Keywords
- EBV-DNA viremia, Allogeneic Hematopoietic Stem Cell Transplantation, EBV-AST cell infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV-AST cellBiological
EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia in patients post-Allo-HSCT.
| Study group | Role | What they receive |
|---|---|---|
| EBV-AST cell infusion | Experimental | EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia in patients post-Allo-HSCT. Receives: Biological: EBV-AST cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of EBV-AST Cell Infusion
The primary outcome measure of the study is to determine the maximum tolerated dose (MTD) of EBV-AST cell infusion in patients with EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). A dose-escalation design (5×10^5, 1×10^6, and 5×10^6 cells/kg) will be used to evaluate safety and tolerability based on the occurrence of dose-limiting toxicities (DLTs).
Measured: Day 1 through 28 days after each EBV-AST cell infusion during the dose escalation phase.
Secondary outcomes (5)
Proportion of Patients Achieving EBV-DNA Negativity
The proportion of patients achieving EBV-DNA negativity following EBV-AST cell infusion.
Measured: 8 weeks and 12 weeks after EBV-AST cell infusion.
Change in EBV-DNA Levels
Change in EBV-DNA viral load from baseline following EBV-AST cell infusion.
Measured: Baseline through 12 weeks after EBV-AST cell infusion.
Time to EBV-DNA Negativity
Time from EBV-AST cell infusion to first documented EBV-DNA negativity.
Measured: Up to 12 weeks after EBV-AST cell infusion.
Absolute Concentration of Circulating EBV-AST Cells in Peripheral Blood at Pre-specified Time Points
Quantification of the absolute number of viable EBV-AST cells per microliter (μL) of peripheral blood using flow cytometry.
Measured: Baseline through 28 days after EBV-AST cell infusion
Change in EBV-Specific T-Cell Frequency in Peripheral Blood
The fold change in the frequency of circulating EBV-specific T cells (LMP1/2-specific, EBNA1-specific) from baseline, as measured by flow cytometry or ELISpot.
Measured: Baseline through 12 weeks after EBV-AST cell infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start26 Mar 2025
- Primary completion26 Mar 2028 (estimated)
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV-DNA ViremiaStudies 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
- 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
- NCT07438067
- Sponsor's protocol ID
- S2025-241
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2026
- Last updated
- 6 Aug 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07438067
- Acronym / sponsor ID
- S2025-241
- Conditions
- EBV-DNA Viremia
- Keywords
- EBV-DNA viremia, Allogeneic Hematopoietic Stem Cell Transplantation, EBV-AST cell infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Daihong LiuUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 26 Mar 2028 (estimated)
- Study completion
- 26 Mar 2028 (estimated)
- First posted
- 27 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBV-AST cell infusion | Experimental | Biological: EBV-AST cellEBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia in patients post-Allo-HSCT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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-AST cellEBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia in patients post-Allo-HSCT. | Biological | EBV-AST cell infusion |
Primary outcome
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.
The primary outcome measure of the study is to determine the maximum tolerated dose (MTD) of EBV-AST cell infusion in patients with EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). A dose-escalation design (5×10^5, 1×10^6, and 5×10^6 cells/kg) will be used to evaluate safety and tolerability based on the occurrence of dose-limiting toxicities (DLTs).
5 secondary outcomes
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.
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 6 Aug 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 study testing EBV-AST cell in people with EBV-DNA Viremia, 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 7 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 6 Aug 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 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.
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?
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.). 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 6 Aug 2026.