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)

  • STATUS
    Recruiting
  • End date
    Dec 9, 2027
  • participants needed
    140
  • sponsor
    Viracta Therapeutics, Inc.
Updated on 9 March 2022
stem cell transplantation
measurable disease

Summary

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

Description

Patients 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, 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:

This is an open-label, multicenter, multinational single-arm, Phase 2 basket design study, utilizing Simon's 2-stage design. The study will include 7 cohorts of patients with the following EBV+ relapsed/refractory lymphomas:

  1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)
  2. Extranodal NK/T-cell lymphoma (ENKTL)
  3. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
  4. Hodgkin lymphoma (HL)
  5. Post-transplant lymphoproliferative disorder (PTLD)
  6. HIV-associated lymphomas (Plasmablastic, Burkitt, Hodgkin, DLBCL)
  7. EBV+ lymphoproliferative disorders other than the above

Details
Condition Epstein-Barr Virus Associated Lymphoproliferative Disorder, EBV-Related PTLD, EBV Related Non-Hodgkin's Lymphoma, Extranodal NK/T-cell Lymphoma, EBV-Positive DLBCL, Nos, EBV Associated Lymphoma, EBV-Related Hodgkin Lymphoma, EBV Related PTCL, Nos
Treatment Nanatinostat in combination with valganciclovir
Clinical Study IdentifierNCT05011058
SponsorViracta Therapeutics, Inc.
Last Modified on9 March 2022

Eligibility

Yes No Not Sure

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

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)
Clear my responses

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