Actively Recruiting
Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
Led by Mayo Clinic · Updated on 2026-04-13
21
Participants Needed
2
Research Sites
429 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �318 years
- Relapsed or refractory peripheral T-cell lymphoma including peripheral T-cell lymphoma-NOS, anaplastic large cell lymphoma, and mycosis fungoides
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2 times upper limit of normal within 15 days prior to registration
- Creatinine less than or equal to 2.0 mg/dL within 15 days prior to registration
- Direct bilirubin less than or equal to 1.5 times upper limit of normal within 15 days prior to registration
- INR/PT and aPTT less than or equal to 1.5 times upper limit of normal within 15 days prior to registration
- Child Pugh score not exceeding class A if baseline liver disease within 15 days prior to registration
- Negative pregnancy test for persons of child-bearing potential within 15 days prior to registration
- Absolute neutrophil count (ANC) greater than or equal to 1,000/microliter within 14 days prior to registration
- Platelets greater than or equal to 100,000/microliter within 14 days prior to registration
- Hemoglobin greater than or equal to 8.5 g/dL within 14 days prior to registration
- Measurable disease by CT or MRI with at least one lesion larger than 2 cm or tumor cells in the blood greater than 5 x 10^9/L
- No active central nervous system involvement
- Ability to provide written informed consent
- Willingness to return to Mayo Clinic for follow-up
- Life expectancy of at least 12 weeks
- ECOG performance status 0, 1, or 2
- Willing to provide mandatory biological specimens for research purposes
You will not qualify if you...
- Availability of and patient acceptance of curative therapy
- Uncontrolled infection
- Active tuberculosis or hepatitis, or chronic hepatitis
- Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) within 2 weeks prior to registration
- Immunotherapy (monoclonal antibodies) within 4 weeks prior to registration
- Experimental agent for AML or T-cell lymphoma within 4 half-lives of last dose
- New York Heart Association class III or IV heart failure, symptomatic coronary artery disease, or cardiac arrhythmias such as atrial fibrillation or supraventricular tachycardia
- Active central nervous system disorder, seizure disorder, known CNS disease or symptoms
- HIV positive or other immunodeficiency or immunosuppression
- Concurrent chemotherapy, immunotherapy, radiotherapy, or investigational ancillary therapy not FDA approved
- Pregnant or unwilling to use effective contraception if of reproductive potential
- Nursing women
- Men unwilling to use condoms during treatment and for 4 weeks after
- Diagnosis of acute myeloid leukemia
- Diagnosis of angioimmunoblastic T-cell lymphoma
- Hypersensitivity to ipilimumab or its excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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