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Not yet recruitingNCT07349836Updated Jan 20, 2026

Application of mRNA Immunotherapy Technology in EB Virus Related Diseases

An Early Phase 1 interventional study of WGc-043 injection and Immune Checkpoint Inhibitors in EBV-associated Tumors, sponsored by Xinqiao Hospital of Chongqing. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Xinqiao Hospital of Chongqing · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • EBV-associated Tumors
03

In context

Lead sponsor

Xinqiao Hospital of Chongqing is the lead sponsor of 69 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 etc;
  • 3. 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 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 form before the experiment;
  • 8. Able to communicate well with researchers and complete experiments according to the protocol.

Exclusion criteria

Exclusion Criteria:

  • 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 ;
  • 3. Chest fluid, ascites, and pericardial effusion that require drainage due to clinical symptoms; Hepatic encephalopathy, hepatorenal syndrome, or 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 , 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 ). 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;
  • 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 ≤ 1 or inclusion criteria after previous anti-tumor therapy;
  • 8. Subjects who receive systemic therapy with (>10 mg/day of prednisone or equivalent doses of other corticosteroids) or other agents within 14 days prior to their first administration. In the absence of active 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 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 virus, 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.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    WGc-043 Injection, monotherapy

    Biological: WGc-043 injection

  • Experimental
    WGc-043 injection, combination therapy

    Biological: WGc-043 injection · Biological: Immune Checkpoint Inhibitors · Drug: Standard therapy

Interventions

  • BiologicalWGc-043 injection

    WGc-043 injection

  • Immune checkpoint inhibitors

  • DrugStandard therapy

    Standard therapy

06

What researchers measure

Primary outcomes

  1. Safety: incidence and severity of adverse effects

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Through study completion, an average of 2 years

  2. Disease control rate (DCR)

    Time frame: Through study completion, an average of 2 years

  3. Progression free survival (PFS)

    Time frame: 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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2026; primary completion for Jan 2028, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2026
First posted
Jan 20, 2026
StartEst.
Jan 10, 2026
Primary completionEst.
Jan 1, 2028
CompletionEst.
Dec 31, 2028
Last update
Jan 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07349836
Lead sponsor
Xinqiao Hospital of Chongqing
Responsible party
Xi Zhang, MD (Professor, Xinqiao Hospital of Chongqing) — Principal investigator
First posted
Jan 20, 2026
Start date
Jan 10, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 20, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Immune checkpoint inhibitors

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