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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus (VSV) carrying the human (h) sodium iodide symporter (NIS) and Interferon (IFN) beta (β) genes (VSV-hIFNβ-NIS) in combination with cemiplimab in patients with T-cell lymphoma. A virus, called VSV-hIFNβ-NIS, which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells. Immunotherapy with ipilmumab and cemiplimab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

Eligibility criteria

Qualifiers

Age >= 18 years

Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 times upper limit of normal (ULN) (obtained =< 15 days prior to registration)

Creatinine =< 2.0 mg/dL (obtained =< 15 days prior to registration)

Disqualifiers

Availability of and patient acceptance of curative therapy

Uncontrolled infection

Active tuberculosis or hepatitis, or chronic hepatitis

Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =< 2 weeks prior to registration

Trial design

Treatments tested in this trial

  • Biopsy
  • Biospecimen Collection
  • Bone Marrow Biopsy
  • Computed Tomography
  • Positron Emission Tomography
  • Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
  • Single Photon Emission Computed Tomography
  • Cemiplimab
  • Ruxolitinib

Treatment groups

21 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator