Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-27 @ 3:21 AM
Study NCT ID:
NCT06789159
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA282411 | NIH | None | https://reporter.nih.gov/quic… | View |
| JT 35884 | OTHER | JeffTrial Number | View |