RecruitingPhase 1NCT06789159

A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)


Sponsor

Thomas Jefferson University

Enrollment

30 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called VK-2019 for people with a specific type of lymphoma — EBV-positive diffuse large B-cell lymphoma (DLBCL). This is an aggressive blood cancer linked to the Epstein-Barr virus (the same virus that causes mononucleosis). The study is for patients whose cancer came back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 years or older - You have EBV-positive DLBCL that has relapsed (come back) or is refractory (not responding) after at least 2 prior treatment regimens - You have exhausted all standard treatment options that might benefit you - You have measurable disease on a scan - Your performance status is ECOG 2 or below (able to carry out some self-care) - Side effects from prior treatment have resolved to mild or stable levels - Your organ function meets required minimums **You may NOT be eligible if...** - You have not tried at least 2 prior treatment regimens - There are still standard treatment options available that could help you - Your prior treatment ended less than 2 weeks ago - You have significant unresolved side effects from prior therapy - Your organ function is not adequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVK-2019

VK-2019 will be administered daily starting on day 1 of cycle 1 (D1C1). Dose cohort A will dose at 600 mg dose cohort B 1200 mg and dose cohort C 1800 mg. Treatment cycles will repeat every 28 days , in the absence of disease progression or unacceptable toxicity.


Locations(1)

Honickman Center

Philadelphia, Pennsylvania, United States

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NCT06789159


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