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EBV-associated TumorsEarly Phase 1NCT07349836

Application of mRNA Immunotherapy Technology in EB Virus Related Diseases

A Early Phase 1 study testing WGc-043 injection, Immune Checkpoint Inhibitors and Standard therapy in people with EBV-associated Tumors, run by Xinqiao Hospital of Chongqing.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

EB virus is associated with various epithelial and lymphoid derived tumors, such as Burkitt lymphoma, Hodgkin lymphoma, epithelial derived nasopharyngeal carcinoma, and some gastric cancers. 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?
WGc-043 injection, Immune Checkpoint Inhibitors and Standard therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
10 Jan 2026to 31 Dec 2028
Phase
Early 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Male or female patients aged ≥ 18 years old;
  • 2. Diagnosed with EBV related diseases through histology or cytology, including but not limited to nasopharyngeal carcinoma, gastric cancer, lymphoma, EBV disease after HSCT etc;
  • 3. ECOG physical condition score: 0-2 points;
  • 4. Expected survival period ≥ 3 months;
  • 5. The main organ functions well, that is, the relevant examination indicators meet the requirements;
  • 6. The subject has no pregnancy plan during the treatment period and agrees to voluntarily take effective contraceptive measures during the trial period and within 4 months of stopping treatment, and the pregnancy of women of childbearing age is negative;
  • 7. Able to understand and voluntarily sign a written informed consent form before the experiment;
  • 8. Able to communicate well with researchers and complete experiments according to the protocol.

Who cannot join

  • 1. The patient has a history of other tumors in the past, except for the cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, gastrointestinal intramucosal carcinoma and other malignant tumors that the researchers think can be included;
  • 2. Central nervous system (CNS) tumors or CNS metastases;
  • 3. Chest fluid, ascites, and pericardial effusion that require drainage due to clinical symptoms; Hepatic encephalopathy, hepatorenal syndrome, or Child Pugh B or more severe cirrhosis;
  • 4. Known to have invasive NK cell leukemia or NK lymphoblastic leukemia/lymphoma; Or accompanied by hemophilic cell syndrome;
  • 5. There are any uncontrollable clinical or mental illnesses or other major illnesses that, according to the researcher's assessment, may hinder the provision of informed consent, interfere with the interpretation of the trial results, pose risks to the subjects participating in this trial, or otherwise affect the achievement of the trial objectives;
  • 6. Allergic to the experimental drug (including any excipients). Previous history of severe allergies to any medication, food, or vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
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  • 7. The most recent anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local regional therapy) is less than 4 weeks after the first dose or within 5 half lives of the drug (whichever is shorter), or palliative radiotherapy is less than 2 weeks after the first dose; Patients with adverse reactions related to anti-tumor therapy (excluding hair loss) that have not recovered to NCI CTCAE ≤ 1 or inclusion criteria after previous anti-tumor therapy;
  • 8. Subjects who receive systemic therapy with corticosteroids (>10 mg/day of prednisone or equivalent doses of other corticosteroids) or other immunosuppressive agents within 14 days prior to their first administration. In the absence of active autoimmune diseases, inhalation or topical use of steroids and adrenal hormone replacement with a dose ≤ 10 mg/day of prednisone efficacy dose is allowed;
  • 9. Within 6 months prior to the first administration, have received mRNA vaccines or lipid nanoparticles (LNP) equivalent nanoparticles for drug delivery;
  • 10. Having undergone major surgery within the 4 weeks prior to screening (excluding minor surgeries such as catheter insertion or biopsy surgery as required by the protocol), or the impact of surgery or trauma has been eliminated for less than 14 days prior to enrollment;
  • 11. Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcohol or drug abuse;
  • 12. Known active infections such as hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), syphilis, etc.:
  • 13. The researchers believe that there are any other factors that are not suitable for the subjects to enter this trial.

About this study

EB virus is associated with various epithelial and lymphoid derived tumors, such as Burkitt lymphoma, Hodgkin lymphoma, epithelial derived nasopharyngeal carcinoma, and some gastric cancers. In EBV related tumors, epithelial tumors account for over 80%, with the majority being nasopharyngeal carcinoma and EVB related gastric cancer. Among lymphomas, NK/T-cell lymphoma is the lymphoma most closely associated with EBV infection, accounting for approximately 6%. In the world, the incidence rate of NK/T lymphoma in China is the highest, and it is a malignant lymphoma with rapid development and strong invasion.

mRNA immunotherapy is a promising novel anti-tumor treatment method. Previous basic research and clinical practice have shown that immune drugs prepared using antigen-presenting cells loaded with tumor antigens, CAR-T cells, etc. can produce objective clinical therapeutic effects. Compared with traditional immune drugs, mRNA immune drugs have unique advantages in the field of tumor immunotherapy. They can express and present antigens for a long time, thereby stimulating stronger immune responses and producing cytotoxic T cells (CTLs) that specifically recognize EB virus antigens, exerting anti-tumor effects.

Previous studies have preliminarily confirmed that the mRNA immunotherapy monotherapy has good safety and tolerability in various tumor populations. Considering that most EBV positive tumor patients have limited treatment options, and that PD-1/L1 inhibitors have shown excellent anti-tumor efficacy in the treatment of various malignant tumors, research on mRNA vaccine monotherapy and its combination with immune checkpoint inhibitors is being conducted to provide more treatment options for patients with EB virus related tumors.

Being tested
WGc-043 injection, Immune Checkpoint Inhibitors, Standard therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WGc-043 injectionBiological

    WGc-043 injection

  • Immune Checkpoint InhibitorsBiological

    Immune checkpoint inhibitors

  • Standard therapyDrug

    Standard therapy

Study groups in NCT07349836
Study groupRoleWhat they receive
WGc-043 Injection, monotherapyExperimentalNot described
Receives: Biological: WGc-043 injection
WGc-043 injection, combination therapyExperimentalNot described
Receives: Biological: WGc-043 injection; Biological: Immune Checkpoint Inhibitors; Drug: Standard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: incidence and severity of adverse effects

    Measured: Through study completion, an average of 2 years

Secondary outcomes (3)

  1. Objective response rate (ORR)

    Measured: Through study completion, an average of 2 years

  2. Disease control rate (DCR)

    Measured: Through study completion, an average of 2 years

  3. Progression free survival (PFS)

    Measured: From date of initial treatment until the date of first comfired progression or date of death from any cause, whichever came first, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start10 Jan 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07349836
Sponsor's protocol ID
LNP-mRNA for EBV
Status last verified
Jan 2026
First submitted
2 Jan 2026
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing WGc-043 injection, Immune Checkpoint Inhibitors and Standard therapy in people with EBV-associated Tumors, run by Xinqiao Hospital of Chongqing.

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 8 inclusion and 13 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 20 Jan 2026. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

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?

Safety: incidence and severity of adverse effects (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07349836.

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 20 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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