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

About

Brief Summary

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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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 ENKTL and PTCL patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. ENKTL 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).

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