Recruiting

Phase 1

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

Sponsor:

Mayo Clinic

Code:

NCT06508463

Conditions

Peripheral T Cell Lymphoma

Relapsed Peripheral T-Cell Lymphoma

Peripheral T-Cell Lymphoma, Not Otherwise Specified

Anaplastic Large Cell Lymphoma

Mycosis Fungoides

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Biospecimen Collection

Bone Marrow Biopsy

Computed Tomography

Positron Emission Tomography

Study Details

Brief 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 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

Study ID

NCT06508463

Start date

Jan 5, 2024

Status verified date

Jun, 2026

Completion date

Apr 1, 2032

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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
ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:

Diagnosis of AML
Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)

Study Design

Enrollment

21 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group E (VSV-IFNβ-NIS, cemiplimab, ruxolitinib) - Peripheral T-cell lymphoma (PTCL) only

PTCL patients receive cemiplimab IV over 30 minutes on day -3 and VSV-IFNβ-NIS IV over 30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients may receive ruxolitinib PO on days 2-6 for symptom management. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.

experimental: Group E (VSV-IFNβ-NIS, cemiplimab, ruxolitinib) - PTCL Expansion Cohort

Interventions

Biopsy

Undergo tumor biopsy

Biospecimen Collection

Undergo blood sample collection

Bone Marrow Biopsy

Undergo bone marrow biopsy

Computed Tomography

Undergo SPECT/CT

Positron Emission Tomography

Undergo PET scan

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

Given IV

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Cemiplimab

Given IV

Ruxolitinib

Given PO

Primary outcome measure

Incidence of adverse events of grade 3 or higher [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Nathan Punwani, M.D.

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Kah Whye Peng, Ph.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-01.