Epstein-Barr Virus-Associated Lymphoproliferative DisordersPhase 1/2NCT07450391
EBV-AST Cell Injection for EBV-Associated Lymphoproliferative Disorders
A Phase 1/2 study testing EBV-AST Cell Injection in people with Epstein-Barr Virus-Associated Lymphoproliferative Disorders and EBV-Positive Lymphoma, run by Daihong Liu at 1 site in China.
Trial summary
This is an investigator-initiated, open-label, single-arm, dose-escalation exploratory study to evaluate the safety, tolerability, and preliminary efficacy of EBV-AST cell injection in adults with EBV-associated lymphoproliferative disorders, including post-transplant lymphoproliferative disease (PTLD) and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epstein-Barr Virus-Associated Lymphoproliferative Disorders, EBV-Positive Lymphoma
- What is being tested?
- EBV-AST 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
- Able to understand and voluntarily sign written informed consent.
- Age 18 to 75 years, inclusive.
- HLA genotype matches at least one of the following: HLA-A02:01, HLA-A11:01, or HLA-A*24:02.
- Karnofsky Performance Status (KPS) ≥ 70.
- Life expectancy ≥ 3 months.
- Diagnosed with EBV-associated lymphoproliferative disorders, including:
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- EBV infection-associated post-transplant lymphoproliferative disorder (PTLD) that is relapsed/refractory after at least first-line standard therapy; or
- EBV-associated lymphoma confirmed by histology and/or cytology with EBER positivity (ISH/FISH), with no standard treatment available or not suitable for standard therapy, including but not limited to: EBV-positive DLBCL, EBV-positive NK/T-cell lymphoma, EBV-positive Hodgkin lymphoma, EBV-positive Burkitt lymphoma, EBV-positive nodal TFH lymphoma (AITL type), and EBV-positive primary cutaneous T-cell lymphoma, meeting protocol-defined relapsed/refractory criteria.
- Absolute lymphocyte count ≥ 0.8 × 10^9/L (except for PTLD participants).
- Adequate organ and bone marrow function per protocol-defined criteria.
- Participants of childbearing potential agree to use highly effective contraception throughout the study; women of childbearing potential must have a negative pregnancy test at screening.
Who cannot join
- Known hypersensitivity to the investigational product or its components.
- Uncontrolled active graft-versus-host disease (GVHD) in PTLD participants.
- Known primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, chronic granulomatous disease, hyper-IgE syndrome).
- Severe uncontrolled medical conditions that, in the investigator's judgment, make the participant unsuitable for enrollment.
- Serious cardiac disease within 6 months prior to first infusion (e.g., myocardial infarction, severe/unstable angina, bypass surgery, NYHA class III-IV heart failure).
- Chronic diseases requiring systemic immunosuppressants or systemic steroids (except local/inhaled steroids or physiologic replacement therapy).
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- History of other malignancy within the past 5 years, except carcinoma in situ (e.g., cervix, bladder, breast) or non-melanoma skin cancer.
- Receipt of lymphocyte-based immunotherapy (e.g., CIK, DC, DC-CIK, LAK) within 3 months prior to consent.
- Receipt of interferon or other targeted immunodeficiency drugs within 3 months prior to consent; prior high-dose IL-2 therapy.
- Anti-cancer therapy within 14 days prior to consent (including chemotherapy or immunosuppressants/steroids); other cell therapy or live vaccines/attenuated vaccines or other investigational drugs within 28 days prior to consent; curative radiotherapy or major surgery within 4 weeks, or palliative local radiotherapy within 2 weeks prior to consent.
- Prior immune therapy-associated ≥ Grade 3 immune-related adverse events (irAEs).
- Unresolved toxicity from prior therapy > Grade 1 (except alopecia any grade; peripheral sensory neuropathy ≤ Grade 2).
- Uncontrolled psychiatric or neurologic disorders; drug abuse or alcohol dependence.
- Positive HIV antibody; positive Treponema pallidum antibody; active hepatitis B (HBsAg and/or HBeAg positive with HBV-DNA above ULN) or active hepatitis C (HCV-Ab positive and HCV-RNA positive).
- Uncontrolled severe active infection or contagious disease (excluding EBV infection).
- Pregnant or breastfeeding women.
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, Beijing Municipality, 100853
Daihong Liu, +8618301339032, daihongrm@163.com
daihongrm@163.com
About this study
Official title: Exploratory Clinical Study of EBV-AST Cell Injection for the Treatment of EBV-Associated Lymphoproliferative Disorders
This is an investigator-initiated, open-label, single-arm, dose-escalation exploratory study to evaluate the safety, tolerability, and preliminary efficacy of EBV-AST cell injection in adults with EBV-associated lymphoproliferative disorders, including post-transplant lymphoproliferative disease (PTLD) and EBV-positive lymphomas. Participants will receive EBV-AST cell infusions intravenously every 2 weeks for up to 3 infusions at escalating dose levels. The primary objective is to assess safety and determine a potential optimal biologically active dose. Secondary objectives include preliminary tumor response and EBV-related virologic outcomes, as well as cellular PK/PD.
Read the detailed description
EBV-associated lymphoproliferative disorders (LPD), including PTLD and EBV-positive lymphomas, are clinically challenging and may occur in immunocompromised or heavily treated patients. EBV-AST is a cellular immunotherapy consisting of EBV antigen-specific cytotoxic T lymphocytes generated by ex vivo stimulation and expansion of T cells using antigen peptide-loaded dendritic cells. After infusion, EBV-AST cells are expected to recognize and eliminate EBV-infected or EBV-antigen-expressing target cells and provide EBV-specific immune reconstitution.
This investigator-initiated, open-label, single-arm exploratory study uses a dose-escalation design to evaluate EBV-AST cell injection in adults with EBV-associated LPD. Approximately 4-18 participants will be enrolled across three dose levels (3×10^5, 3×10^6, and 3×10^7 cells/kg per infusion). EBV-AST will be administered by intravenous infusion every 2 weeks for up to three infusions, following protocol-defined escalation rules and DLT assessment within 28 days after the first infusion. Participants will be monitored for adverse events and immune-related toxicities, and assessed for preliminary efficacy (tumor response and EBV-DNA/virologic outcomes) and cellular PK/PD.
- Being tested
- EBV-AST Cell Injection
- Keywords
- EBV-associated lymphoproliferative disorder, EBV-positive lymphoma, Adoptive T-cell therapy, Antigen-specific T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV-AST Cell InjectionBiological
EBV-AST is an Epstein-Barr virus (EBV) antigen-specific cytotoxic T-lymphocyte product generated by ex vivo stimulation and expansion of T cells using peptide-loaded dendritic cells. EBV-AST is administered by intravenous infusion every 2 weeks for up to 3 infusions at escalating dose levels (3×10^5, 3×10^6, or 3×10^7 cells/kg per infusion), according to the protocol-defined dose-escalation design.
| Study group | Role | What they receive |
|---|---|---|
| EBV-AST Cell Injection | Experimental | Participants with EBV-associated lymphoproliferative disorders (including PTLD and EBV-positive lymphomas) will receive EBV-AST cell injection by intravenous infusion in a dose-escalation scheme. EBV-AST is administered every 2 weeks for up to 3 infusions (Day 0, Day 14, and Day 28). Three dose levels are planned: 3×10^5, 3×10^6, and 3×10^7 cells/kg per infusion, with dose-escalation decisions based on safety and protocol-defined criteria. Receives: Biological: EBV-AST Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLTs)
Number of participants experiencing dose-limiting toxicities (DLTs) within 28 days after the first EBV-AST cell infusion, as defined by protocol-specific criteria and graded according to NCI CTCAE v5.0.
Measured: From first infusion (Day 0) through Day 28
Safety: Incidence of Adverse Events
Number of participants with treatment-emergent adverse events (AEs), immune-related adverse events (irAEs), and serious adverse events (SAEs), graded according to NCI CTCAE v5.0, including clinically significant laboratory abnormalities.
Measured: From first infusion (Day 0) through 12 months after first infusion
Recommended/Optimal Biologically Active Dose (OBD)
Recommended/optimal biologically active dose (OBD) of EBV-AST, determined based on the incidence of DLTs, overall safety profile, and tolerability across dose levels.
Measured: Up to 28 days after first infusion for DLT evaluation; overall dose decision through study completion
Secondary outcomes (10)
Objective Response Rate (ORR)
Objective response rate (ORR), defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to protocol-defined response criteria.
Measured: From first infusion (Day 0) through 12 months after first infusion
Disease Control Rate (DCR)
Disease control rate (DCR), defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to protocol-defined criteria.
Measured: From first infusion (Day 0) through 12 months after first infusion
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from first EBV-AST infusion to documented disease progression or death from any cause.
Measured: From first infusion (Day 0) through 12 months after first infusion
Overall Survival (OS)
Overall survival (OS), defined as the time from first EBV-AST infusion to death from any cause.
Measured: From first infusion (Day 0) through 12 months after first infusion
Duration of Response (DOR)
Duration of response (DOR), defined as the time from first documented complete or partial response to disease progression or death.
Measured: From first documented response through 12 months after first infusion
EBV-DNA Negativity Rate
Proportion of participants achieving EBV-DNA negativity in peripheral blood as measured by quantitative polymerase chain reaction (qPCR).
Measured: From first infusion (Day 0) through 12 months after first infusion
Time to EBV-DNA Negativity
Time from first EBV-AST infusion to first documented EBV-DNA negativity in peripheral blood.
Measured: From first infusion (Day 0) through 12 months after first infusion
Change in EBV-DNA Level
Change from baseline in EBV-DNA levels in peripheral blood over time, as measured by quantitative polymerase chain reaction (qPCR).
Measured: From baseline through 12 months after first infusion
Maximum Concentration (Cmax) of EBV-AST Cells in Peripheral Blood
The highest measured absolute concentration of viable EBV-AST cells in peripheral blood following infusion, quantified by flow cytometry.
Measured: From first infusion (Day 0) through Day 28
Concentration of EBV-AST Cells in Peripheral Blood (Cmax)
Maximum absolute concentration of viable EBV-AST cells in peripheral blood post-infusion, quantified by flow cytometry. Unit of Measure: viable EBV-AST cells per microliter (cells/μL).
Measured: From baseline through Day 28 after first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 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-Associated Lymphoproliferative DisordersStudies 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
- Investigators
- Daihong Liu, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450391
- Sponsor's protocol ID
- S2025-726-02
- Status last verified
- Feb 2026
- First submitted
- 25 Dec 2025
- Last updated
- 4 Mar 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of EBV-AST Cell Injection for the Treatment of EBV-Associated Lymphoproliferative Disorders
- ClinicalTrials.gov ID
- NCT07450391
- Acronym / sponsor ID
- S2025-726-02
- Keywords
- EBV-associated lymphoproliferative disorder, EBV-positive lymphoma, Adoptive T-cell therapy, Antigen-specific T cells
- 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
- 4 Mar 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 is an investigator-initiated, open-label, single-arm, dose-escalation exploratory study to evaluate the safety, tolerability, and preliminary efficacy of EBV-AST cell injection in adults with EBV-associated lymphoproliferative disorders, including post-transplant lymphoproliferative disease (PTLD) and EBV-positive lymphomas. Participants will receive EBV-AST cell infusions intravenously every 2 weeks for up to 3 infusions at escalating dose levels. The primary objective is to assess safety and determine a potential optimal biologically active dose. Secondary objectives include preliminary tumor response and EBV-related virologic outcomes, as well as cellular PK/PD.
Detailed description
EBV-associated lymphoproliferative disorders (LPD), including PTLD and EBV-positive lymphomas, are clinically challenging and may occur in immunocompromised or heavily treated patients. EBV-AST is a cellular immunotherapy consisting of EBV antigen-specific cytotoxic T lymphocytes generated by ex vivo stimulation and expansion of T cells using antigen peptide-loaded dendritic cells. After infusion, EBV-AST cells are expected to recognize and eliminate EBV-infected or EBV-antigen-expressing target cells and provide EBV-specific immune reconstitution.
This investigator-initiated, open-label, single-arm exploratory study uses a dose-escalation design to evaluate EBV-AST cell injection in adults with EBV-associated LPD. Approximately 4-18 participants will be enrolled across three dose levels (3×10^5, 3×10^6, and 3×10^7 cells/kg per infusion). EBV-AST will be administered by intravenous infusion every 2 weeks for up to three infusions, following protocol-defined escalation rules and DLT assessment within 28 days after the first infusion. Participants will be monitored for adverse events and immune-related toxicities, and assessed for preliminary efficacy (tumor response and EBV-DNA/virologic outcomes) and cellular PK/PD.
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 Injection | Experimental | Biological: EBV-AST Cell InjectionParticipants with EBV-associated lymphoproliferative disorders (including PTLD and EBV-positive lymphomas) will receive EBV-AST cell injection by intravenous infusion in a dose-escalation scheme. EBV-AST is administered every 2 weeks for up to 3 infusions (Day 0, Day 14, and Day 28). Three dose levels are planned: 3×10^5, 3×10^6, and 3×10^7 cells/kg per infusion, with dose-escalation decisions based on safety and protocol-defined criteria. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to understand and voluntarily sign written informed consent.
- Age 18 to 75 years, inclusive.
- HLA genotype matches at least one of the following: HLA-A02:01, HLA-A11:01, or HLA-A*24:02.
- Karnofsky Performance Status (KPS) ≥ 70.
- Life expectancy ≥ 3 months.
Key exclusion criteria (16 listed)
- Known hypersensitivity to the investigational product or its components.
- Uncontrolled active graft-versus-host disease (GVHD) in PTLD participants.
- Known primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, chronic granulomatous disease, hyper-IgE syndrome).
- Severe uncontrolled medical conditions that, in the investigator's judgment, make the participant unsuitable for enrollment.
- Serious cardiac disease within 6 months prior to first infusion (e.g., myocardial infarction, severe/unstable angina, bypass surgery, NYHA class III-IV heart failure).
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 Cell InjectionEBV-AST is an Epstein-Barr virus (EBV) antigen-specific cytotoxic T-lymphocyte product generated by ex vivo stimulation and expansion of T cells using peptide-loaded dendritic cells. EBV-AST is administered by intravenous infusion every 2 weeks for up to 3 infusions at escalating dose levels (3×10^5, 3×10^6, or 3×10^7 cells/kg per infusion), according to the protocol-defined dose-escalation design. | Biological | EBV-AST Cell Injection |
Primary outcome
Dose-Limiting Toxicities (DLTs)
Time frame: From first infusion (Day 0) through Day 28
Number of participants experiencing dose-limiting toxicities (DLTs) within 28 days after the first EBV-AST cell infusion, as defined by protocol-specific criteria and graded according to NCI CTCAE v5.0.
Safety: Incidence of Adverse Events
Time frame: From first infusion (Day 0) through 12 months after first infusion
Number of participants with treatment-emergent adverse events (AEs), immune-related adverse events (irAEs), and serious adverse events (SAEs), graded according to NCI CTCAE v5.0, including clinically significant laboratory abnormalities.
Recommended/Optimal Biologically Active Dose (OBD)
Time frame: Up to 28 days after first infusion for DLT evaluation; overall dose decision through study completion
Recommended/optimal biologically active dose (OBD) of EBV-AST, determined based on the incidence of DLTs, overall safety profile, and tolerability across dose levels.
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first infusion (Day 0) through 12 months after first infusion
Disease Control Rate (DCR)
Time frame: From first infusion (Day 0) through 12 months after first infusion
Progression-Free Survival (PFS)
Time frame: From first infusion (Day 0) through 12 months after first infusion
Overall Survival (OS)
Time frame: From first infusion (Day 0) through 12 months after first infusion
Duration of Response (DOR)
Time frame: From first documented response through 12 months after first infusion
EBV-DNA Negativity Rate
Time frame: From first infusion (Day 0) through 12 months after first infusion
Time to EBV-DNA Negativity
Time frame: From first infusion (Day 0) through 12 months after first infusion
Change in EBV-DNA Level
Time frame: From baseline through 12 months after first infusion
Maximum Concentration (Cmax) of EBV-AST Cells in Peripheral Blood
Time frame: From first infusion (Day 0) through Day 28
Concentration of EBV-AST Cells in Peripheral Blood (Cmax)
Time frame: From baseline through Day 28 after first 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 4 Mar 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.
Daihong Liu study chair
Chinese PLA General Hospital
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-AST Cell Injection in people with Epstein-Barr Virus-Associated Lymphoproliferative Disorders and EBV-Positive Lymphoma, 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 11 inclusion and 16 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 4 Mar 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?
Dose-Limiting Toxicities (DLTs) (time frame: From first infusion (Day 0) through Day 28). The study lists 3 primary outcomes in all. 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 4 Mar 2026.