Phase I Study of VSV-hIFNbeta-NIS Vaccine Alone or With Cyclophosphamide and Immunotherapy for Relapsed or Resistant Blood Cancers Including Multiple Myeloma, Leukemia, and Lymphoma

What this Trial Is About

Researchers are evaluating the best dose and side effects of a modified vesicular stomatitis virus vaccine called VSV-hIFNb2-NIS, alone or combined with cyclophosphamide and immunotherapy drugs ipilimumab, nivolumab, and cemiplimab. This phase I trial focuses on patients with relapsed or refractory multiple myeloma, acute myeloid leukemia, or lymphoma that has returned or not responded to previous treatments. The study aims to find the maximum tolerated dose and assess safety, clinical response, and survival outcomes for these patients. Participants are assigned to one of several groups receiving different combinations of treatments. These include intravenous infusions of VSV-hIFNb2-NIS, cyclophosphamide, cemiplimab, nivolumab, ipilimumab, and oral ruxolitinib on specific days. The study also involves advanced imaging techniques like PETCT and SPECTCT scans, biopsies of tumors or lymph nodes, and collection of blood, urine, and buccal cell samples. Some groups have closed enrollment, while others continue with expansion cohorts. During the trial, participants undergo screening with scans and lab tests, then receive treatments as scheduled. Follow-up visits occur on days 15 and 29, at 6 weeks, and then every 3 months up to one year or until disease progression, followed by visits every 6 months until 2 years after registration. Researchers monitor adverse events, clinical responses, progression-free survival, overall survival, viral distribution, immune cell responses, and pharmacodynamics through various laboratory and imaging assessments throughout the study.

A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma