Loading clinical trials...

Mechanistic Study of EBV mRNA Vaccine (WGc-043) in EBV-Positive Relapsed/Refractory Lymphoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

Mechanistic Study of EBV mRNA Vaccine (WGc-043) in EBV-Positive Relapsed/Refractory Lymphoma

An EBV mRNA Vaccine (WGc-043 Injection) in Patients With EB Virus-positive Relapsed or Refractory Lymphoma: A Phase I Clinical Trial Assessing the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Anti-tumor Activity

NCT06788600•Ruijin Hospital

View on ClinicalTrials.gov

Summary

This exploratory study, based on a pharmaceutical company-initiated clinical trial, aims to investigate the therapeutic effects of the EBV mRNA vaccine (WGc-043 injection) in treating EBV-positive relapsed or refractory lymphoma. The study explores the mechanism of the EBV mRNA vaccine (WGc-043 injection) within the tumor microenvironment in EBV-positive lymphoma, elucidating the vaccine's inhibitory effects on EBV. This research will provide a theoretical foundation for the application of mRNA vaccines, either alone or in combination with other immunotherapies, in the treatment of EBV-positive lymphoma.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patients aged 18 to 75 years (inclusive).
•2. Histologically or cytologically diagnosed as relapsed or refractory EBV-positive lymphoma (confirmed by in situ hybridization (ISH) or fluorescence in situ hybridization (FISH) showing EBER positivity in tumor tissue) that has failed standard treatment and lacks effective treatment options. This includes, but is not limited to, NK/T-cell lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), or other Peripheral T-cell Lymphomas (PTCL).Relapse is defined as the appearance of new lesions in the primary site or elsewhere after achieving complete remission (CR).
•(1)Refractory is defined by any of the following conditions: No partial response (PR) after ≥2 cycles of treatment. No CR after ≥4 cycles of treatment. No complete remission (CR) after autologous hematopoietic stem cell transplantation.
•If the best response or reason for discontinuation is progressive disease (PD), no cycle number requirements apply.
•(2)Prior treatment must include:
•1. Relapsed/Refractory DLBCL: Must have received at least second-line systemic therapy.
•2. Relapsed/Refractory Peripheral T-cell Lymphoma: Must have received at least first-line systemic therapy.
•3. Relapsed/Refractory NK/T-cell Lymphoma: Must have received a regimen based on L-asparaginase (I/II stage diseases as per the nasal NK/T-cell lymphoma CA staging system must have also received radiotherapy).
•3.Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2 points. 4.Expected survival ≥3 months. 5.At least one measurable lesion as defined by the Lymphoma Classification (2014 version), with measurable lesions defined as:
•1. A lymph node lesion with a maximum long diameter \>15 mm on enhanced CT, MRI, or PET-CT.
+12 more criteria

Exclusion Criteria

•1. Patients with a history of other tumors, except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, gastrointestinal mucosal carcinoma, or other malignancies considered acceptable by the investigator, provided these were treated and have not recurred within the last 5 years.
•2. Known to have aggressive NK-cell leukemia; central nervous system (CNS) lymphoma or CNS metastases; or associated hemophagocytic syndrome.
•3. Known to have poorly controlled cardiac clinical symptoms or diseases, such as NYHA Class II heart failure or higher (see Appendix 4, section 16.4), unstable angina, myocardial infarction within the past 6 months, or clinically significant and treatable supraventricular or ventricular arrhythmias.
•4. Any active autoimmune disease or history of autoimmune diseases, including but not limited to immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel diseases including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (except for Type 1 diabetes managed with stable doses of insulin).
•5. Any uncontrolled clinical disease (e.g., respiratory, circulatory, digestive, neurological, hematological, urogenital, endocrine diseases) or mental illness (e.g., depression, schizophrenia) or other significant illnesses that, in the investigator's assessment, could hinder informed consent, interfere with the interpretation of trial results, pose risks to the subject from participation, or otherwise affect the trial's objectives.
•6. History of interstitial lung disease or suspected interstitial lung disease; or presence of pulmonary abnormalities that may interfere with the detection or management of potential drug-related pulmonary toxicity during the trial.
•7. Allergies to the investigational drug (including any excipients). A history of severe allergic reactions to any drugs, foods, or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, or local allergic necrotizing reactions (Arthus reactions).
•8. Any abnormalities at the injection site or permanent body art (e.g., tattoos) that the investigator believes may hinder observation of local reactions at the injection site.
•9. Contraindications to intramuscular injection (see Appendix 5, section 16.5).
•10. Less than 4 weeks since the last anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local-regional therapy) or less than 2 weeks since palliative radiotherapy; patients with treatment-related adverse reactions (excluding hair loss) from previous anti-tumor therapy that have not recovered to NCI CTCAE ≤ 1 level.
+14 more criteria

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 1, 2025

Primary Completion Date

October 31, 2026

Completion Date

October 31, 2026

Last Updated

April 2, 2025

Enrollment

ESTIMATED participants

Conditions

Epstein-Barr Virus Associated Lymphoma

Interventions

EBV mRNA vaccine (WGc-043)

DRUG

Contacts

Weili Zhao

CONTACT

+862164370045 zwl_trial@163.com

Pengpeng Xu

CONTACT

+862164370045 pengpeng_xu@126.com