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

Description

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomasPatients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas: 1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS) 2. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL 3. Post-transplant lymphoproliferative disorder (PTLD) 4. EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (E

Trial Eligibility

Key Inclusion Criteria: * EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent. * For EBV+ PTLD patients: Relapsed/refractory disease following 1 prior therapy and must have received at least 1 course of an anti-CD20 immunotherapy. For patients with EBV+ PTLD only, age 12 years and older and weighing greater than 40 kg (Adolescent, Adult, Older Adult) are allowed * For other EBV+ relapsed/refractory lymphoma: Following at least 1 course of an anit-CD20 immunotherapy and at least 1 course of anthracycline-based chemotherapy (unless contraindicated) * 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 Cheson 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).

Study Info

Interventions

Locations Recruiting

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