Mechanistic Study of EBV mRNA Vaccine (WGc-043) in EBV-Positive Relapsed/Refractory Lymphoma (NCT06788600) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mechanistic Study of EBV mRNA Vaccine (WGc-043) in EBV-Positive Relapsed/Refractory Lymphoma
China15 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients aged 18 to 75 years (inclusive).
. 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).
. Relapsed/Refractory DLBCL: Must have received at least second-line systemic therapy.
. Relapsed/Refractory Peripheral T-cell Lymphoma: Must have received at least first-line systemic therapy.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ScRNA-seq profiles of tumor tissues before and after injection
Timeframe: If the patient receives personalized treatment, safety follow-up will be conducted 28 days after the last infusion; if not, safety follow-up will be conducted 28 days after the 5th dose.
2
Clinical data from patients with disease remission (CR/PR) and those without remission (SD/PD)
Timeframe: If the patient receives personalized treatment, safety follow-up will be conducted 28 days after the last infusion; if not, safety follow-up will be conducted 28 days after the 5th dose.
.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:
. A lymph node lesion with a maximum long diameter \>15 mm on enhanced CT, MRI, or PET-CT.
. An extranodal lesion with a maximum long diameter \>10 mm. 6.Adequate organ function as evidenced by the following criteria:
Exclusion criteria
. 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.
. Known to have aggressive NK-cell leukemia; central nervous system (CNS) lymphoma or CNS metastases; or associated hemophagocytic syndrome.
. 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.
. 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).
. 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.
. 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.
. 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).
. 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.