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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06508463
Phase
PHASE1
Status
Recruiting
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Conditions

  • Anaplastic Large Cell Lymphoma
  • Mycosis Fungoides
  • Peripheral T Cell Lymphoma
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Relapsed Anaplastic Large Cell Lymphoma
  • Relapsed Mycosis Fungoides
  • Relapsed Peripheral T-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter — BIOLOGICAL
    Given IV
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Ruxolitinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jan 5, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Apr 1, 2032

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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
    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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Nathan Punwani, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Kah Whye Peng, Ph.D. (PRINCIPAL_INVESTIGATOR)
Nora Bennani, M.D. (PRINCIPAL_INVESTIGATOR)

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