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

Last updated: December 5, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Lymphoproliferative Disorders

Non-hodgkin's Lymphoma

Treatment

Biospecimen Collection

Cemiplimab

Biopsy

Clinical Study ID

NCT06508463
MC1684 Arm E
P30CA015083
R01CA262613
MC1684
16-005474
NCI-2017-00049
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age >= 18 years

  • Relapsed or refractory:

  • Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the followinghistologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)

  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 times upperlimit 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 partialthromboplastin time (aPTT) =< 1.5 x ULN (obtained =< 15 days prior to registration)

  • If baseline liver disease, Child Pugh score not exceeding class A (obtained =< 15days prior to registration)

  • Negative pregnancy test for persons of child-bearing potential (obtained =< 15 daysprior 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 toregistration)

  • 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): musthave at least one lesion that has a single diameter of > 2 cm or tumor cells in theblood > 5 x 10^9/L; NOTE: skin lesions can be used if the area is > 2 cm in at leastone diameter and photographed with a ruler and the images are available in themedical record

  • Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollmentlumbar 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

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 priorto registration

  • Immunotherapy (monoclonal antibodies) =< 4 weeks prior to registration

  • Experimental agent in case of Acute Myeloid Leukemia (AML) or TCL within 4half-lives of the last dose of the agent

  • New York Heart Association classification III or IV, known symptomatic coronaryartery disease, or symptoms of coronary artery disease on systems review, or knowncardiac arrhythmias [atrial fibrillation or supraventricular tachycardia (SVT)]

  • Active CNS disorder or seizure disorder or known CNS disease or neurologicsymptomatology; in case of AML active CNS involvement as detected by lumbar punctureor neuro-imaging (only to be done if clinically indicated)

  • Human immunodeficiency virus (HIV) positive test result or other immunodeficiency orimmunosuppression

  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapyconsidered 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, aceticacid soaks, etc. to control pruritis and prevent infection; no topicalchemotherapy is allowed (no topical nitrogen mustard)

  • Any of the following because this study involves an investigational agent whosegenotoxic, mutagenic and teratogenic effects on the developing fetus and newborn areunknown:

  • Pregnant women or women of reproductive ability who are unwilling to useeffective contraception

  • Nursing women

  • Men who are unwilling to use a condom (even if they have undergone a priorvasectomy) while having intercourse with any woman, while taking the drug andfor 4 weeks after stopping treatment

  • ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH IPILIMUMAB ANDCEMIPLIMAB) ONLY:

  • Diagnosis of AML

  • Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)

  • Hypersensitivity to ipilimumab or its excipients

Study Design

Total Participants: 20
Treatment Group(s): 9
Primary Treatment: Biospecimen Collection
Phase: 1
Study Start date:
January 05, 2024
Estimated Completion Date:
April 01, 2032

Study Description

PRIMARY OBJECTIVE: To determine the maximum tolerated dose (MTD) of VSV-hIFNβ-NIS in combination with ipilimumab and cemiplimab in patients with T-cell lymphoma [Group E].

Patients undergo computed tomography (CT) scan, position emission tomography (PET) scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.

After completion of study treatment, patients are followed up for 28 days, and then every 3 months for up to 1 year or until progressive disease, then every 6 months for 1 year.

Connect with a study center

  • Mayo Clinic in Arizona

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.