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

NCT06789159 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-09-02

No results posted yet for this study

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.

Conditions

  • Diffuse Large B Cell Lymphoma Refractory
  • Diffuse Large B Cell Lymphoma Relapsed
  • Epstein-Barr Virus (EBV) Infection

Interventions

DRUG

VK-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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Wistar Institute

    collaborator OTHER

  • Pierluigi Porcu

    lead OTHER

Principal Investigators

  • Pierluigi Porcu, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-21
Primary Completion
2028-10-01
Completion
2028-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789159 on ClinicalTrials.gov