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.
PRIMARY OBJECTIVE: To determine the maximum tolerated dose (MTD) of VSV-hIFNβ-NIS in combination with ipilimumab and cemiplimab in patients with T-cell lymphoma \[Group E\]. Patients undergo computed tomography (CT) scan, position emission tomography (PET) scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study. After completion of study treatment, patients are followed up for 28 days, and then every 3 months for up to 1 year or until progressive disease, then every 6 months for 1 year.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Undergo tumor biopsy
Undergo blood sample collection
Undergo bone marrow biopsy
Undergo SPECT/CT
Undergo PET scan
Given IV
Undergo SPECT/CT
Given IV
Given IV
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
RECRUITINGMayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGIncidence of adverse events of grade 3 or higher
Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: Up to 2 years
Clinical response
Response to treatment will be recorded as stringent Complete Response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), Minimal Response (MR), stable disease (SD), and progressive disease (PD).
Time frame: Up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from study enrollment to disease progression or death due to any cause.
Time frame: Up to 2 years
Overall survival (OS)
OS is defined as the time from study enrollment to death due to any cause.
Time frame: Up to 2 years
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