VSV-hIFNβ-NIS Vaccine with Immunotherapies for Relapsed/Refractory Cancers
This study is testing a vaccine called VSV-hIFNβ-NIS, sometimes with cyclophosphamide, and combinations of ipilimumab, nivolumab, and cemiplimab. It's for adults whose multiple myeloma, acute myeloid leukemia, or lymphoma has returned or isn't responding to treatment. The main goal is to find the safest dose of the VSV-hIFNβ-NIS vaccine and to see how well these treatments work. You may be eligible if you are 18 or older and have relapsed or refractory disease, with specific prior treatments for multiple myeloma or certain types of T-cell lymphoma. The study is currently unclear about its recruitment status and plans to enroll 99 participants.
- Study design
- This is a phase I interventional study aiming to determine the maximum tolerated dose of the VSV-hIFNβ-NIS vaccine, alone or in combination with other drugs, in approximately 99 participants.
- What's involved
- You would undergo procedures such as tumor or lymph node biopsies, blood sample collection, bone marrow biopsies, and SPECT/CT scans. Cyclophosphamide, if part of your treatment, would be given intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track adverse events (side effects) of grade 3 or higher for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03017820
A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~99 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionBone Marrow BiopsyComputed TomographyCyclophosphamidePositron Emission Tomography
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events of grade 3 or higher
Measured over Up to 2 years
Conditions
Where it's being run
2 sites across 2 statesArizona1
Minnesota1
Study leadership
- Nora Bennani, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
- Joselle Cook, M.B.B.S. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>= 18 years
Relapsed or refractory disease as follows:
Groups A, B, C or D: Multiple myeloma (MM) previously treated with an immunomodulatory imide drug (IMID), a proteosome inhibitor, and an alkylating agent
All Groups except D: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and mycosis fungoides (MF). Patients should have failed standard therapy and in the case of PTCL-NOS, AITL, and ALCL either have failed or be ineligible for high-dose therapy with autologous stem cell transplant
Group B and C only: B-cell lymphoma (other than Burkitt's lymphoma), or histiocytic/dendritic cell neoplasms (HCN) at any stage
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)
Group F only: Expansion Cohort for B-cell lymphoma (other than Burkitt's lymphoma) with low tumor burden
Group G only: Expansion Cohort for peripheral T cell lymphoma (PTCL) with low tumor burden
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 MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:
Serum monoclonal protein \>= 1.0 g/dL by protein electrophoresis
\>= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
Serum immunoglobulin free light chain \>= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
FOR MULTIPLE MYELOMA ONLY: Absolute neutrophil count (ANC) \>= 1000/uL (obtained =\< 14 days prior to registration)
FOR MULTIPLE MYELOMA ONLY: Platelet (PLT) \>= 100,000/uL (obtained =\< 14 days prior to registration)
FOR MULTIPLE MYELOMA ONLY: Hemoglobin \>= 8.5 g/dl (obtained =\< 14 days prior to registration)
FOR AML ONLY: No ANC restriction (obtained =\< 14 days prior to registration)
FOR AML ONLY: PLT \>= 10,000/uL (transfusion to get platelets \>= 10,000 is allowed) (obtained =\< 14 days prior to registration)
FOR AML ONLY: Hemoglobin \>= 7.5 g/dl (obtained =\< 14 days prior to registration)
FOR AML ONLY: Absence of uncompensated disseminated intravascular coagulation (DIC- as diagnosed by standard International Society on Thrombosis and Hemostasis \[ISTH\] criteria)
FOR TCL/BCL ONLY: ANC \>= 1,000/uL (obtained =\< 14 days prior to registration)
FOR TCL/BCL ONLY: PLT \>= 100,000/uL (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
FOR HCN ONLY: ANC \>= 1,000/uL obtained =\< 15 days prior to registration
FOR HCN ONLY: PLT \>= 100,000/uL obtained =\< 15 days prior to registration
FOR HCN ONLY: Hemoglobin \>= 8.0 g/dl obtained =\< 15 days prior to registration
FOR HCN ONLY: Measurable disease by CT or MRI: Must have at least one lesion that has a single diameter of \>= 1.5 cm or tumor cells in the blood \>5 x10\^9/L. NOTE: Skin lesions can be used if the area is \>= 1.5 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
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 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 AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol;
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
AML ONLY: Current disseminated intravascular coagulopathy (DIC)
Diagnosis of AML
Multiple myeloma only: \> 25% plasma cells or plasmacytoma \> 5cm in largest diameter
Lymphoma or HCN only: Any mass \>5cm
Diagnosis of Burkitt's lymphoma
Diagnosis of AML
Diagnosis of Burkitt's lymphoma
Diagnosis of AML
Diagnosis of Burkitt's lymphoma
Diagnosis of AML
Diagnosis of AITL
Diagnosis of Burkitt's lymphoma
Diagnosis of cutaneous TCL
What this trial measures
- Incidence of adverse events of grade 3 or higherUp to 2 years
Assessed by the Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by cohort and overall). Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with a 95% exact binomial confidence.