RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 28 days, 1 year
  • Procedures mentioned: CT scans, Blood draws, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests the best dose and side effects of a changed virus called VSV-hIFNβ-NIS, given through a vein with cemiplimab. The virus may kill cancer cells, and cemiplimab helps the immune system fight cancer. The study is for adults with certain T-cell lymphomas, cancers of immune cells, that have come back or have not improved with treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have lymphoma that has come back or resisted treatment. Group E requires peripheral T-cell lymphoma-NOS, anaplastic large cell lymphoma, or mycosis fungoides that has come back.
  • Meet required liver, kidney, and blood-clotting test limits. If you have liver disease, it must be in the mildest Child-Pugh class, class A.
  • For T-cell or B-cell lymphoma: have enough infection-fighting white blood cells, platelets that help stop bleeding, and hemoglobin that carries oxygen.
  • For T-cell or B-cell lymphoma: have a tumor larger than 2 cm on a scan, a skin tumor larger than 2 cm photographed with a ruler, or enough tumor cells in the blood.
  • Have no active cancer in the brain or spinal cord. Be able to care for yourself and be out of bed for at least half the day, and be expected to live at least 12 weeks.
  • Have a negative pregnancy test if you could become pregnant.
  • Give written consent, agree to provide required research samples, and return to Mayo Clinic for follow-up.

Who can't join

  • Have an available treatment that could cure the cancer and agree to receive it.
  • Have an uncontrolled infection, active tuberculosis, active or long-term hepatitis, HIV, or another condition that weakens or suppresses the immune system.
  • Had chemotherapy within 2 weeks or antibody-based immune treatment within 4 weeks before signing up. Recent experimental drugs may also exclude you, depending on how long they stay in the body.
  • Have severe heart failure, heart artery disease with symptoms, or certain abnormal heart rhythms.
  • Have an active brain or spinal cord disorder, a seizure disorder, known brain or spinal cord disease, or symptoms of nervous system problems.
  • Are receiving other chemotherapy, immune treatment, radiation, or experimental treatment. Some skin treatments for itching and infection prevention are allowed for T-cell lymphoma, but skin chemotherapy is not.
  • Are pregnant, breastfeeding, or able to become pregnant but unwilling to use effective birth control. Men must use condoms during sex with women during treatment and for 4 weeks after, even after a vasectomy.
  • For Group E with cemiplimab: have acute myeloid leukemia (AML), a blood cancer, or angioimmunoblastic T-cell lymphoma (AITL).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

AZ

MN