Clinical Research Directory

Inclusion Criteria: 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; * 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. Exclusion Criteria: 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; * 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.