Trial Title:
Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
NCT ID:
NCT06508463
Condition:
Peripheral T Cell Lymphoma
Relapsed Peripheral T-Cell Lymphoma
Peripheral T-Cell Lymphoma, Not Otherwise Specified
Anaplastic Large Cell Lymphoma
Mycosis Fungoides
Relapsed Anaplastic Large Cell Lymphoma
Relapsed Mycosis Fungoides
Conditions: Official terms:
Mycoses
Vesicular Stomatitis
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Mycosis Fungoides
Lymphoma, Large-Cell, Anaplastic
Stomatitis
Iodine
Interferons
Interferon-beta
Ipilimumab
Cemiplimab
Immunoglobulins
Immunoglobulin G
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo tumor biopsy
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Marrow Biopsy
Description:
Undergo bone marrow biopsy
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
Biopsy of Bone Marrow
Other name:
Biopsy, Bone Marrow
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET scan
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Biological
Intervention name:
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Description:
Given IV
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
Oncolytic VSV-hIFNbeta-NIS
Other name:
Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Other name:
Voyager-V1
Other name:
VSV-expressing hIFNb and NIS
Other name:
VSV-hIFNb-NIS
Other name:
VSV-hIFNbeta-NIS
Other name:
VV1
Other name:
VSV-hIFNβ-NIS
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
Medical Imaging, Single Photon Emission Computed Tomography
Other name:
Single Photon Emission Tomography
Other name:
Single-Photon Emission Computed
Other name:
single-photon emission computed tomography
Other name:
SPECT
Other name:
SPECT imaging
Other name:
SPECT SCAN
Other name:
SPET
Other name:
ST
Other name:
tomography, emission computed, single photon
Other name:
Tomography, Emission-Computed, Single-Photon
Intervention type:
Biological
Intervention name:
Cemiplimab
Description:
Given IV
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
1801342-60-8
Other name:
Cemiplimab RWLC
Other name:
Cemiplimab-rwlc
Other name:
Immunoglobulin G4
Other name:
Anti-(Human Programmed Cell Death Protein 1) (Human Monoclonal REGN2810 Heavy Chain)
Other name:
Disulfide with Human Monoclonal REGN2810 kappa-chain
Other name:
Libtayo
Other name:
REGN2810
Intervention type:
Biological
Intervention name:
Ipilimumab
Description:
Given IV
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
Arm group label:
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
Other name:
Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
Other name:
BMS-734016
Other name:
Ipilimumab Biosimilar CS1002
Other name:
MDX-010
Other name:
MDX-CTLA4
Other name:
Yervoy
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.
Detailed 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.
Criteria for 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 pruritis 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 IPILIMUMAB AND
CEMIPLIMAB) ONLY:
- Diagnosis of AML
- Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)
- Hypersensitivity to ipilimumab or its excipients
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Javier L. Munoz, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Kah Whye Peng, Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Nora Bennani, M.D.
Email:
Principal Investigator
Start date:
January 5, 2024
Completion date:
April 1, 2032
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06508463
https://www.mayo.edu/research/clinical-trials
