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

Phase 1

Not yet recruiting

• Conditions: Diffuse Large B Cell Lymphoma Refractory; Diffuse Large B Cell Lymphoma Relapsed; Epstein-Barr Virus (EBV) Infection
• Interventions: Drug: VK-2019

• Registration Number: NCT06789159
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Detailed Description

This is an open label, dose-escalation phase Ib study with biomarker assessments to determine the safety and tolerability of single agent VK-2019 in patients with relapsed or refractory EBV-positive lymphomas.

Each treatment cycle is comprised of a daily dose of VK-2019 administered orally for 28 days with a response assessment every 3 cycles. All subjects will be monitored for survival for 3 years.

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. Should dose cohort 1 result in unacceptable toxicity, the protocol will be amended to include a dose (-1) cohort of VK-2019 given in the same fashion as above.

Patients who achieve at least stable disease (SD, PR, or CR) after completing 3 cycles can continue receiving therapy. Patients who have progressive disease (PD) after cycle 3 will discontinue protocol treatment. All patients will be followed for a total of 3 years.

Protocol therapy will be discontinued at any time if a patient withdraws consent, has progressive disease, unacceptable toxicity, or pregnancy is suspected.

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Study Start: 2025-05-15
• Primary Completion: 2028-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety Dose- Maximum Tolerated Dose	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.	• The maximum tolerated dose (MTD) of single agent VK-2019 based upon treatment emergent AE (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 5.0).

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States