NCT05011058

An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Viracta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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, 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. Diffuse large B-cell lymphoma (DLBCL) 2. Extranodal natural killer/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS) 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorders (PTLD) 6. Human immunodeficiency virus (HIV)-associated lymphomas (HIV-L) 7. EBV+ lymphomas other than the above The study was terminated prematurely and did not reach its target enrollment.

Conditions

• Epstein-Barr Virus Associated Lymphoma
• EBV-Positive DLBCL, NOS
• EBV-Related Non-Hodgkin Lymphoma
• EBV Related PTCL, NOS
• EBV-Related Hodgkin Lymphoma
• EBV-Related PTLD
• EBV-Related Lymphoproliferative Disorder

Interventions

Type	Name	Description
DRUG	Nanatinostat in combination with valganciclovir	Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles Drug: Valganciclovir, 900 mg orally once daily in 28 day cycles

Timeline

• Start date: 2021-05-28
• Primary completion: 2024-12-26
• Completion: 2025-01-31
• First posted: 2021-08-18
• Last updated: 2025-07-28
• Results posted: 2025-07-28

Locations

62 sites across 14 countries: United States, Australia, Brazil, Canada, France, Germany, Israel, Italy, Malaysia, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study