Clinical activity of single-dose systemic oncolytic VSV virotherapy in patients with relapsed refractory T-cell lymphoma.
Joselle Cook, Kah-Whye Peng, Thomas E Witzig...
https://pubmed.ncbi.nlm.nih.gov/35175355Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06508463
MC1684 Phase I Trial of Intravenous Vesicular Stomatitis Virus Expressing Human Interferon Beta and Sodium-Iodide Symporter with Cemiplimab in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
Led by Mayo Clinic · Updated on 2026-05-28
21
Participants Needed
2
Research Sites
169 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
Researchers are evaluating a new treatment combination for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), including subtypes such as anaplastic large cell lymphoma and mycosis fungoides. This phase I trial studies the best dose and side effects of a genetically modified vesicular stomatitis virus (VSV) carrying human interferon beta and sodium iodide symporter genes (VSV-hIFNβ-NIS) alongside cemiplimab. The trial aims to find the maximum tolerated dose of this combination and observe its effects on the immune system and tumor growth. Participants receive intravenous infusions of VSV-hIFNβ-NIS on day 1 and cemiplimab on day -3, each administered over 30 minutes. This treatment is given as long as there is no disease progression or unacceptable side effects. Throughout the study, patients undergo imaging procedures including SPECT, CT, and PET scans. They may also have tumor and bone marrow biopsies and blood sample collections to monitor treatment effects and disease status. During the study, patients are closely followed for side effects and treatment responses. After completing the treatment, they are monitored for 28 days, then every three months for up to one year or until disease progression, followed by check-ups every six months for another year. The main outcome measured is the occurrence of serious adverse events, with secondary outcomes including clinical response, progression-free survival, and overall survival, assessed up to two years.
CONDITIONS
Brief Title
Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Relapsed or refractory peripheral T-cell lymphoma including PTCL-NOS, anaplastic large cell lymphoma, or mycosis fungoides
- Liver enzymes ALT and AST not more than 2 times the upper limit of normal within 15 days before registration
- Creatinine level less than or equal to 2.0 mg/dL within 15 days before registration
- Direct bilirubin less than or equal to 1.5 times the upper limit of normal within 15 days before registration
- INR/PT and aPTT less than or equal to 1.5 times the upper limit of normal within 15 days before registration
- If baseline liver disease, Child Pugh score class A or better within 15 days before registration
- Negative pregnancy test for persons who can become pregnant within 15 days before registration
- Absolute neutrophil count 1,000/microliter or higher within 14 days before registration
- Platelet count 100,000/microliter or higher within 14 days before registration
- Hemoglobin 8.5 g/dl or higher within 14 days before registration
- Measurable disease by CT or MRI with at least one lesion larger than 2 cm or tumor cells in blood over 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 acceptance of curative therapy
- Uncontrolled infection
- Active tuberculosis, hepatitis, or chronic hepatitis
- Chemotherapy within 2 weeks before registration
- Immunotherapy (monoclonal antibodies) within 4 weeks before registration
- Experimental agents for AML or TCL within 4 half-lives of last dose
- New York Heart Association class III or IV heart failure, symptomatic coronary artery disease, or cardiac arrhythmias like atrial fibrillation or supraventricular tachycardia
- Active central nervous system disorder or seizure disorder
- Known CNS disease or neurological symptoms
- HIV positive or other immunodeficiency or immunosuppression
- Concurrent chemotherapy, immunotherapy, radiotherapy, or investigational ancillary therapies (except certain topical treatments for TCL)
- Pregnant or nursing women
- Men unwilling to use condoms during and for 4 weeks after treatment
- Diagnosis of acute myeloid leukemia or angioimmunoblastic T-cell lymphoma
- Hypersensitivity to ipilimumab or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Until disease progression or unacceptable toxicity
Participants receive intravenous VSV-hIFNβ-NIS on Day 1 and cemiplimab on Day -3. They undergo scans and biopsies throughout treatment to monitor their condition.
Multiple visits for scans and biopsies throughout treatment
Follow-up
Duration - Up to 2 years
After completing treatment, participants are followed up for 28 days, then every 3 months for up to 1 year or until progressive disease, and then every 6 months for 1 additional year.
Regular follow-up visits every 3 months for 1 year, then every 6 months for 1 year
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
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Research Team
C
Clinical Trials Referral Office
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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