An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viracta Therapeutics, Inc.
• Treatments: Valganciclovir

Criteria

Key Inclusion Criteria:

• EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies

• EBV+ DLBCL, NOS: Must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy

• PTLD: Must have received immunotherapy with an anti-CD20 agent.

• Hodgkin lymphoma: Must have received at least one course of anthracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.

• For extranodal NK/T-cell lymphoma patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. Patients must have failed an asparaginase-containing regimen.

• No available therapies in the opinion of the Investigator

• Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy

• Measurable disease per Lugano 2007

• ECOG performance status 0, 1, 2

• Adequate bone marrow function

Key Exclusion Criteria:

• Presence or history of CNS involvement by lymphoma

• Systemic anticancer therapy or CAR-T within 21 days

• Antibody (anticancer) agents within 28 days

• Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant

• Less than 90 days from prior allogeneic transplant.

• Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1

• Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.

• Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).