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Study of VSV-hIFNβ-NIS and Cemiplimab for T-cell Lymphoma

This study is testing a new approach for people with relapsed or difficult-to-treat peripheral T-cell lymphoma (PTCL), including specific types like PTCL-NOS, anaplastic large cell lymphoma (ALCL), and mycosis fungoides (MF). It's looking at the safety and best dose of a modified virus called VSV-hIFNβ-NIS, which is designed to target cancer cells, when given with cemiplimab. Cemiplimab is an immunotherapy that works by changing your body's immune system to fight cancer. The study aims to see how well these treatments work together and what side effects might occur. You may be able to join if you are 18 or older and have relapsed or refractory PTCL, with specific liver function test results.

Study design
This is a Phase 1 interventional study aiming to enroll 21 participants. It is designed to find the maximum tolerated dose of the treatments.
What's involved
You would undergo procedures like CT scans, PET scans, and potentially tumor biopsies, bone marrow biopsies, and blood sample collections throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed for 28 days, then every 3 months for up to 1 year or until your disease progresses, and then every 6 months for another year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06508463

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~21 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionBone Marrow BiopsyComputed TomographyPositron Emission TomographyRecombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events of grade 3 or higher
Measured over Up to 2 years

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

Explore related trials

Anaplastic Large Cell LymphomaMycosis FungoidesPeripheral T-Cell Lymphoma, Not Otherwise Specified

NCT06508463

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Arizona

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kah Whye Peng, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
  • Nora Bennani, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

Age \>= 18 years
Relapsed or refractory:
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)
Direct bilirubin =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
If baseline liver disease, Child Pugh score not exceeding class A (obtained =\< 15 days prior to registration)
Negative pregnancy test for persons of child-bearing potential (obtained =\< 15 days prior to registration)
FOR T-Cell Lymphoma (TCL)/B-Cell Lymphoma (BCL) ONLY: Absolute Neutrophil Count (ANC) \>= 1,000/microliter (μL) (obtained =\< 14 days prior to registration)
FOR TCL/BCL ONLY: Platelets \>= 100,000/μL (obtained =\< 14 days prior to registration)
FOR TCL/BCL ONLY: Hemoglobin \>= 8.5 g/dl (obtained =\< 14 days prior to registration)
FOR TCL/BCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \> 2 cm or tumor cells in the blood \> 5 x 10\^9/L; NOTE: skin lesions can be used if the area is \> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record
Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory
Ability to provide written informed consent
Willingness to return to Mayo Clinic for follow-up
Life expectancy \>= 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Willing to provide mandatory biological specimens for research purposes

Exclusion

Availability of and patient acceptance of curative therapy
Uncontrolled infection
Active tuberculosis or hepatitis, or chronic hepatitis
Any of the following prior therapies:
Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\< 2 weeks prior to registration
Immunotherapy (monoclonal antibodies) =\< 4 weeks prior to registration
Experimental agent in case of Acute Myeloid Leukemia (AML) or TCL within 4 half-lives of the last dose of the agent
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \[atrial fibrillation or supraventricular tachycardia (SVT)\]
Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)
Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \[FDA\] approved indication and in the context of a research investigation);
NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
Pregnant women or women of reproductive ability who are unwilling to use effective contraception
Nursing women
Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
Diagnosis of AML
Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)

What this trial measures

  • Incidence of adverse events of grade 3 or higherUp to 2 years

    Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.