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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WGc-043 Injection, monotherapy | Experimental |
| |
| WGc-043 injection, combination therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WGc-043 injection | Biological | WGc-043 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence and severity of adverse effects | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Through study completion, an average of 2 years | |
| Disease control rate (DCR) | Through study completion, an average of 2 years | |
| Progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| Immune Checkpoint Inhibitors | Biological | Immune checkpoint inhibitors |
|
| Standard therapy | Drug | Standard therapy |
|
| 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 |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |