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

Summary

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 ipilimumab and 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.

Conditions

• Peripheral T Cell Lymphoma
• Relapsed Peripheral T-Cell Lymphoma
• Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Anaplastic Large Cell Lymphoma
• Mycosis Fungoides
• Relapsed Anaplastic Large Cell Lymphoma
• Relapsed Mycosis Fungoides

Interventions

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo SPECT/CT

PROCEDURE

Positron Emission Tomography

Undergo PET scan

BIOLOGICAL

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

Given IV

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

BIOLOGICAL

Cemiplimab

Given IV

BIOLOGICAL

Ipilimumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Kah Whye Peng, PhD · Mayo Clinic in Rochester

• Nora Bennani, MD · Mayo Clinic in Rochester

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-05

Primary Completion

2028-12-31

Completion

2032-04-01

FDA Drug

Yes

Countries

• United States

Study Locations