RecruitingPhase 1NCT06508463

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

MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms


Sponsor

Mayo Clinic

Enrollment

21 participants

Start Date

Jan 5, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a virus-based cancer therapy — vesicular stomatitis virus (VSV), given through an IV — in patients with a type of blood cancer called peripheral T-cell lymphoma (PTCL) that has come back or stopped responding to treatment. The virus is designed to selectively attack and destroy cancer cells. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with relapsed or refractory peripheral T-cell lymphoma (PTCL-NOS, anaplastic large cell lymphoma, or mycosis fungoides) - Your liver enzymes, kidney function, and blood clotting are within acceptable ranges **You may NOT be eligible if...** - Your liver enzymes (ALT/AST) are significantly elevated - Your kidney function (creatinine) or bilirubin levels are too high - You have serious blood clotting abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo SPECT/CT

PROCEDUREPositron Emission Tomography

Undergo PET scan

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

Given IV

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT

BIOLOGICALCemiplimab

Given IV

BIOLOGICALIpilimumab

Given IV


Locations(2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT06508463


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