An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)

Prior treatment

• Systemic anticancer therapy or CAR 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.

Other illness

• Presence or history of central nervous system (CNS) involvement by lymphoma.
• 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.

• Adult patients age ≥18 years or as permitted by applicable local regulations at the time of providing informed consent. Patients must be able to swallow whole tablets. a. For patients with PTLD: Age ≥12 years and weighing ≥40 kg
• Measurable disease per Lugano 2007.
• ECOG performance status 0, 1, 2.
• Adequate bone marrow function.
• EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
• Patients must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy
• Hodgkin lymphoma: Must have received at least one course of antracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
• For patients with ENKTL: Relapsed/refractory disease following 1 or more prior systemic therapies. Patients must have failed an a sparaginase-containing regimen.
• For patients with PTCL (PTCL, NOS and AITL): relapsed or refractory disease following 1 (2 for France) or more prior systemic therapies with a curative intent.
• For patients with PTLD: Patients with relapsed or refractory EBV+ PTLD who have received at least one prior therapy must have received at least one course of an antiCD20 immunotherapy such as rituximab. For solid-organ transplant (SOT) patients, prior therapy also includes chemotherapy, administered concurrently or sequentially, unless chemotherapy is inappropriate.
• 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.