Phase I Study of Intravenous VSV-hIFN-NIS Combined with Cemiplimab for Relapsed or Refractory Peripheral T-cell Lymphoma

What this Trial Is About

This research aims to find the best dose and assess side effects of a modified virus called recombinant vesicular stomatitis virus VSV carrying human sodium iodide symporter and interferon beta genes VSV-hIFN-NIS, combined with cemiplimab, in patients with T-cell lymphoma. The study focuses on relapsed or refractory peripheral T-cell lymphoma and explores how this viral and immunotherapy combination may affect cancer cells and the immune system. Participants receive cemiplimab through an intravenous infusion three days before getting the VSV-hIFN-NIS virus intravenously on day 1, as long as their disease does not progress and side effects are manageable. Some patients may also take ruxolitinib by mouth for symptom relief. Throughout the study, patients undergo various imaging scans such as SPECT, CT, and PET scans. Tumor biopsies, bone marrow biopsies, and blood samples may also be collected. After treatment, patients are monitored closely for 28 days, then every three months for up to one year or until their disease worsens, followed by check-ups every six months for an additional year. Researchers measure side effects of grade 3 or higher and track clinical response, progression-free survival, and overall survival for up to two years. Participants provide consent and biological samples to support research during their involvement, which may last several years.

Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma