EBV-associated TumorsNCT07101536
The Application of mRNA Immunotherapy Technology in Refractory Malignancies Associated With Epstein-Barr Virus (EBV)
A study testing EBV mRNA vaccine and Immune Checkpoint Inhibitors, ICIs in people with EBV-associated Tumors, run by West China Hospital.
Trial summary
Epstein-Barr virus (EBV) is an important tumor-associated virus. In 1997, the World Health Organization (WHO) officially classified EBV as a Group 1 carcinogen, as it is implicated in the pathogenesis of various epithelial malignancies and multiple types of lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EBV-associated Tumors
- What is being tested?
- EBV mRNA vaccine and Immune Checkpoint Inhibitors, ICIs
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1: Monotherapy Study of mRNA Vaccine
- Male or female patients aged ≥18 years;
- Patients with advanced Epstein-Barr virus (EBV)-positive tumors (e.g., nasopharyngeal carcinoma, NK/T-cell lymphoma, or gastric cancer) who have failed at least two lines of standard therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;
- Estimated survival ≥3 months;
- Adequate major organ function;
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- Additional inclusion criteria may be supplemented.
- Phase 2: Combination Therapy Study of mRNA Vaccine
- Male or female patients aged ≥18 years at screening;
- Histopathologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) not amenable to local therapy, with documented failure of at least one prior platinum-containing chemotherapy regimen and PD-1/L1 immunotherapy;
- Positive for Epstein-Barr virus-encoded RNA (EBER) in tumor tissue;
- At least one measurable lesion per RECIST v1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;
- Additional inclusion criteria may be supplemented.
Who cannot join
- Phase 1: Monotherapy Study of mRNA Vaccine
- Participation in another clinical drug trial within the past 4 weeks;
- History of other malignancies, unless it is cervical carcinoma in situ, treated cutaneous squamous cell carcinoma or urothelial tumors, or other malignancies that have undergone curative treatment (at least 5 years prior to enrollment);
- Uncontrolled cardiac symptoms or diseases;
- Female subjects who are pregnant or breastfeeding;
- Active tuberculosis, bacterial or fungal infections; active HIV infection, active HBV infection, or HCV infection;
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- Additional exclusion criteria may be supplemented.
- Phase 2: Combination Therapy Study of mRNA Vaccine
- History of other primary malignancies within 3 years prior to the first dose, excluding adequately treated tumors with no evidence of recurrence for at least 2 years;
- Known clinically significant uncontrolled cardiac symptoms or diseases;
- Presence of central nervous system disorders (e.g., epilepsy, severe cerebrovascular stenosis), or history of cerebrovascular accident (e.g., stroke) or other cerebrovascular events within 6 months prior to screening, or other conditions (including psychiatric disorders) with overt neurological symptoms;
- Known history of interstitial pneumonia or high suspicion of interstitial pneumonia; or presence of pulmonary abnormalities that may interfere with the detection or management of suspected drug-related pulmonary toxicity during the trial;
- Any active autoimmune disease or history of autoimmune diseases;
- Additional exclusion criteria may be supplemented.
About this study
Epstein-Barr virus (EBV) is an important tumor-associated virus. In 1997, the World Health Organization (WHO) officially classified EBV as a Group 1 carcinogen, as it is implicated in the pathogenesis of various epithelial malignancies and multiple types of lymphomas. Epithelial malignancies associated with EBV infection include nasopharyngeal carcinoma (NPC), gastric cancer, colorectal cancer, breast cancer, cervical cancer, prostate cancer, and oral cancer, among others. Currently, optimal therapeutic strategies for EBV-associated tumors remain lacking, particularly in patients with recurrent, metastatic, or refractory disease. Furthermore, although EBV infection plays a significant role in the development and progression of EBV-positive tumors and may influence patient prognosis, there are currently no precision therapeutic approaches specifically targeting EBV-positive lymphomas. Thus, treatment options for this patient population warrant further attention.
EBV mRNA vaccine is a therapeutic vaccine based on messenger RNA (mRNA) targeting antigens related to EBV. This clinical trial aims to evaluate the safety, tolerability, immunogenicity, and preliminary antitumor activity of EBV mRNA vaccine in patients with advanced EBV-positive malignant tumors, thereby providing a scientific basis for subsequent clinical development.
- Conditions
- EBV-associated Tumors
- Being tested
- EBV mRNA vaccine, Immune Checkpoint Inhibitors, ICIs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV mRNA vaccineBiological
EBV mRNA vaccine
Immune Checkpoint Inhibitors, ICIsBiological
Immune Checkpoint Inhibitors, ICIs
| Study group | Role | What they receive |
|---|---|---|
| EBV mRNA vaccine, Dose 1 | Experimental | Not described Receives: Biological: EBV mRNA vaccine |
| EBV mRNA vaccine, Dose 2 | Experimental | Not described Receives: Biological: EBV mRNA vaccine |
| EBV mRNA vaccine, Dose 3 | Experimental | Not described Receives: Biological: EBV mRNA vaccine |
| EBV mRNA vaccine, Expanded dose | Experimental | Not described Receives: Biological: EBV mRNA vaccine |
| EBV mRNA vaccine, Combination therapy | Experimental | Not described Receives: Biological: EBV mRNA vaccine; Biological: Immune Checkpoint Inhibitors, ICIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Measured: During one year after initial treatment
Safety: Type, frequency, and severity of treatment-related adverse events
Measured: During one year after initial treatment
Secondary outcomes (4)
Objective response rate (ORR)
Measured: During one year after initial treatment
Disease control rate (DCR)
Measured: During one year after initial treatment
Progression-free survival (PFS)
Measured: During one year after initial treatment
Survival rate (1-year, 2-year)
Measured: During one and two years after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV-associated TumorsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101536
- Sponsor's protocol ID
- EBV-mRNA-2025
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of mRNA Immunotherapy Technology in Refractory Malignancies Associated With Epstein-Barr Virus (EBV)
- ClinicalTrials.gov ID
- NCT07101536
- Acronym / sponsor ID
- EBV-mRNA-2025
- Conditions
- EBV-associated Tumors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Aug 2025 (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) is an important tumor-associated virus. In 1997, the World Health Organization (WHO) officially classified EBV as a Group 1 carcinogen, as it is implicated in the pathogenesis of various epithelial malignancies and multiple types of lymphomas. Epithelial malignancies associated with EBV infection include nasopharyngeal carcinoma (NPC), gastric cancer, colorectal cancer, breast cancer, cervical cancer, prostate cancer, and oral cancer, among others. Currently, optimal therapeutic strategies for EBV-associated tumors remain lacking, particularly in patients with recurrent, metastatic, or refractory disease. Furthermore, although EBV infection plays a significant role in the development and progression of EBV-positive tumors and may influence patient prognosis, there are currently no precision therapeutic approaches specifically targeting EBV-positive lymphomas. Thus, treatment options for this patient population warrant further attention.
EBV mRNA vaccine is a therapeutic vaccine based on messenger RNA (mRNA) targeting antigens related to EBV. This clinical trial aims to evaluate the safety, tolerability, immunogenicity, and preliminary antitumor activity of EBV mRNA vaccine in patients with advanced EBV-positive malignant tumors, thereby providing a scientific basis for subsequent clinical development.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EBV mRNA vaccine, Dose 1 | Experimental | Biological: EBV mRNA vaccine |
| EBV mRNA vaccine, Dose 2 | Experimental | Biological: EBV mRNA vaccine |
| EBV mRNA vaccine, Dose 3 | Experimental | Biological: EBV mRNA vaccine |
| EBV mRNA vaccine, Expanded dose | Experimental | Biological: EBV mRNA vaccine |
| EBV mRNA vaccine, Combination therapy | Experimental | Biological: EBV mRNA vaccine, Biological: Immune Checkpoint Inhibitors, ICIs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Phase 1: Monotherapy Study of mRNA Vaccine
- Male or female patients aged ≥18 years;
- Patients with advanced Epstein-Barr virus (EBV)-positive tumors (e.g., nasopharyngeal carcinoma, NK/T-cell lymphoma, or gastric cancer) who have failed at least two lines of standard therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;
- Estimated survival ≥3 months;
Key exclusion criteria (14 listed)
- Phase 1: Monotherapy Study of mRNA Vaccine
- Participation in another clinical drug trial within the past 4 weeks;
- History of other malignancies, unless it is cervical carcinoma in situ, treated cutaneous squamous cell carcinoma or urothelial tumors, or other malignancies that have undergone curative treatment (at least 5 years prior to enrollment);
- Uncontrolled cardiac symptoms or diseases;
- Female subjects who are pregnant or breastfeeding;
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 mRNA vaccineEBV mRNA vaccine | Biological | EBV mRNA vaccine, Combination therapy, EBV mRNA vaccine, Dose 1, EBV mRNA vaccine, Dose 2, EBV mRNA vaccine, Dose 3, EBV mRNA vaccine, Expanded dose |
| Immune Checkpoint Inhibitors, ICIsImmune Checkpoint Inhibitors, ICIs | Biological | EBV mRNA vaccine, Combination therapy |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: During one year after initial treatment
Safety: Type, frequency, and severity of treatment-related adverse events
Time frame: During one year after initial treatment
4 secondary outcomes
Objective response rate (ORR)
Time frame: During one year after initial treatment
Disease control rate (DCR)
Time frame: During one year after initial treatment
Progression-free survival (PFS)
Time frame: During one year after initial treatment
Survival rate (1-year, 2-year)
Time frame: During one and two years after initial treatment
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 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EBV mRNA vaccine and Immune Checkpoint Inhibitors, ICIs in people with EBV-associated Tumors, run by West China Hospital.
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 14 inclusion and 14 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: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: During one year after initial treatment). The study lists 2 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 3 Aug 2025.