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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT03017820
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-Cell Non-Hodgkin Lymphoma
  • Histiocytic and Dendritic Cell Neoplasm
  • Myelodysplastic Syndrome
  • Previously Treated Myelodysplastic Syndrome
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Anaplastic Large Cell Lymphoma
  • Recurrent Angioimmunoblastic T-Cell Lymphoma
  • Recurrent Mycosis Fungoides
  • Recurrent Plasma Cell Myeloma
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Recurrent T-Cell Non-Hodgkin Lymphoma
  • Refractory Acute Myeloid Leukemia
  • Refractory Anaplastic Large Cell Lymphoma
  • Refractory Angioimmunoblastic T-Cell Lymphoma
  • Refractory Mycosis Fungoides
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Refractory Plasma Cell Myeloma
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory T-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor or lymph node biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Cyclophosphamide — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter — BIOLOGICAL
    Given IV
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Ruxolitinib — DRUG
    Given PO
  • Nivolumab — BIOLOGICAL
    Given IV
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration

Study Details

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.

Key Dates

Start date
Apr 4, 2017
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Apr 1, 2032

Study Design

Enrollment
99 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (VSV-hIFNbeta-NIS, ruxolitinib)
    \*\* Group A no longer enrolling \*\* Closed with Amendment 10, 9/18/2025.
  • Experimental: Group B (VSV-hIFNbeta-NIS, ruxolitinib)
    \*\* Group B no longer enrolling \*\* Closed with Amendment 11, 5/21/2026
  • Experimental: Group C (VSV-hIFNbeta-NIS, ruxolitinib, cyclophosphamide)
    \*\* Group C no longer enrolling \*\* Closed with Amendment 10, 9/18/2025.
  • Experimental: Group D (VSV-IFNbeta-NIS, ruxolitinib, nivolumab, ipilimumab) - MM only
    \*\* Group D no longer enrolling \*\* Closed with Amendment 10, 9/18/2025.
  • Experimental: Group E (VSV-IFNbeta-NIS, cemiplimab, ruxolitinib - PTCL only
    PTCL patients receive cemiplimab IV over 30 minutes on day -3 and VSV-hIFNβ-NIS IV over 30-60 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients may receive ruxolitinib PO on days 2-6 for symptom management. Patients also undergo PET/CT at baseline and then as clinically indicated, biopsy, and blood, buccal cell, and urine sample collection throughout the study. Patients undergo echocardiography or MUGA scan during screening as well as optional biopsy of imaging positive area on study.
  • Experimental: Group F (VSV-IFNbeta-NIS, ruxolitinib) - BCL Expansion Cohort
    BCL patients receive VSV-IFNbeta-NIS IV over 30 minutes on day 1 and ruxolitinib PO on days 2-6 in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT during screening and as clinically indicated thereafter, bone marrow aspiration and biopsy, tumor or lymph node biopsy, and collection of blood, buccal cells, and urine throughout the study. Patients undergo echocardiography or MUGA scan during screening as well as optional biopsy of imaging positive area on study.
  • Experimental: Group G (VSV-IFNbeta-NIS, ruxolitinib) - PTCL Expansion Cohort
    PTCL patients receive VSV-IFNbeta-NIS IV over 30 minutes on day 1 and ruxolitinib PO on days 2-6 in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT during screening and as clinically indicated thereafter, bone marrow aspiration and biopsy, tumor or lymph node biopsy, and collection of blood, buccal cells, and urine throughout the study. Patients undergo echocardiography or MUGA scan during screening as well as optional biopsy of imaging positive area on study.

Primary Outcome Measure

Incidence of adverse events of grade 3 or higher [ Time Frame: Up to 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Nathan L. Punwani, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Nora Bennani, M.D. (PRINCIPAL_INVESTIGATOR)
Joselle Cook, M.B.B.S. (PRINCIPAL_INVESTIGATOR)

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