RecruitingPhase 1NCT03017820

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

MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms


Sponsor

Mayo Clinic

Enrollment

127 participants

Start Date

Apr 4, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the best dose and side effects of the VSV-hIFNβ-NIS vaccine with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab in treating patients with multiple myeloma, acute myeloid leukemia or lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). VSV-IFNβ-NIS is a modified version of the vesicular stomatitis virus (also called VSV). This virus can cause infection and when it does it typically infects pigs, cattle, or horses but not humans. The VSV used in this study has been altered by having two extra genes (pieces of DNA) added. The first gene makes a protein called NIS that is inserted into the VSV. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in the body (which organs). The second addition is a gene for human interferon beta (β) or hIFNβ. Interferon is a natural anti-viral protein, intended to protect normal healthy cells from becoming infected with the virus. VSV is very sensitive to the effect of interferon. Many tumor cells have lost the capacity to either produce or respond to interferon. Thus, interferon production by tumor cells infected with VSV-IFNβ-NIS will protect normal cells but not the tumor cells. The VSV with these two extra pieces is referred to as VSV-IFNβ-NIS. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, and cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab may be safe and effective in treating patients with recurrent peripheral T-cell lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a modified virus (used as a vaccine) combined with immune-boosting drugs to treat blood cancers — including multiple myeloma, certain leukemias, and lymphomas — that have come back or stopped responding to other treatments. **You may be eligible if...** - You are 18 or older with multiple myeloma, certain T-cell or B-cell lymphomas, or acute myeloid leukemia (AML) that has returned or has not responded to standard therapy - Your liver, kidneys, and blood counts meet the required levels - You are willing to return to the study site for follow-up visits - You are in reasonable physical condition (ECOG performance status 0, 1, or 2) **You may NOT be eligible if...** - A curative treatment option is available to you - You have an active or uncontrolled infection, active tuberculosis, or active hepatitis - You are HIV positive or have an immune deficiency - You are pregnant, breastfeeding, or unwilling to use contraception - You have a serious heart condition (Class III or IV heart failure) - You have active central nervous system (brain) disease or seizures - You received chemotherapy within the past 2 weeks or immunotherapy within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tumor or lymph node biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo SPECT/CT

DRUGCyclophosphamide

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET scan

BIOLOGICALRecombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter

Given IV

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT

BIOLOGICALCemiplimab

Given IV

DRUGRuxolitinib

Given PO

BIOLOGICALipilimumab

Given IV

BIOLOGICALNivolumab

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA scan

PROCEDUREEchocardiography Test

Undergo echocardiography

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration


Locations(2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT03017820


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