A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lym… (NCT06789159) | Clinical Trial Compass
RecruitingPhase 1
A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)
United States30 participantsStarted 2026-06
Plain-language summary
This is a Phase Ib in adult patients with relapsed or refractory EBV-positive DLBCL using daily oral dosing of VK-2019 in three dose escalation cohorts: 600 mg/day, 1200 mg/day, 1800 mg/day for 28 days (cycle), until progression or toxicity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed consent obtained prior to any protocol mandated assessment.
. Age ≥ 18 years.
. Patient must have relapsed or refractory EBV-positive DLBCL after a minimum of 2 prior regimens of systemic therapy.
. Patient must have exhausted all available standard of care treatment options that could potentially provide clinical benefit.
. Toxicities related to prior therapy must have returned to Grade 1 or less, or if chronic must be stable. Peripheral neuropathy must be Grade 2 or less
. Prior anti-cancer treatment must have been completed greater than 2 weeks prior to study day 1.
. Patients must have measurable disease, as defined by IWG 2007 criteria.
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.
1Since this is a Phase 1 trial focused on finding the maximum tolerated dose of VK-2019, what does that mean for what's currently known about its safety and whether it's likely to help my specific type of lymphoma?
2My lymphoma has been confirmed as EBV-positive — is that the kind of testing my care team has already done, or would I need additional testing to even be considered for a study like this?
3This trial isn't recruiting yet — given how quickly relapsed or refractory DLBCL can progress, is waiting for this study to open realistic, or should we be prioritizing other treatment options right now?
4Are there standard salvage therapies or other trials already enrolling that I should consider before or alongside looking into a Phase 1 study like this one?
5If this trial does open and I were to discuss enrolling, what would the treatment schedule and monitoring visits likely look like, and is that something that would be manageable given my current situation?
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
Safety Dose- Maximum Tolerated Dose
Timeframe: At the end of Cycle 1 (each cycle is 28 days), until disease progression or unacceptable toxicity. All Patients will be followed for a total of 3 years.
. Patients with severe or active symptomatic cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders; patents with effectively treated conditions (e.g. stenting for CAD) are eligible.
. Patients with metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain or leptomeningeal involvement.
. Concurrent administration of herbal preparations.
. A serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.
. Patients currently taking drugs that inhibit or induce OATP1B1 or OATP1B3 within 5 half- lives of that agent. Examples are included in Appendix B.
. Patients currently taking drugs that are proton pump inhibitors (PPIs) within 5 half- lives of that agent. Examples are included in Appendix B.
. Patients who have received a prior organ allograft or allogeneic bone marrow transplant are eligible but must have no evidence of active GVHD and be off immunosuppressive drugs.
. Current non-prescription drug or alcohol dependence;