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Application of mRNA Immunotherapy Technology in EB Virus Related Diseases

ConditionEBV-associated Tumors
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorXinqiao Hospital of Chongqing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • WGc-043 injection

    Biological/Vaccine

    WGc-043 injection

  • Immune Checkpoint Inhibitors

    Biological/Vaccine

    Immune checkpoint inhibitors

  • Standard therapy

    Drug

    Standard therapy

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: WGc-043 Injection, monotherapyExperimental treatment 1 intervention
Group B: WGc-043 injection, combination therapyExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinqiao Hospital of Chongqing

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: