Engineered virus targets Hard-to-Treat blood cancers in new trial
NCT ID NCT03017820
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a genetically modified virus (VSV-IFNβ-NIS) alone or with chemotherapy and immunotherapy drugs in people with blood cancers like multiple myeloma, acute myeloid leukemia, and lymphomas that have returned or not responded to treatment. The virus is designed to infect and kill cancer cells while protecting healthy cells. The main goal is to find the safest dose and understand side effects. About 99 adults will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2017
- Expected to finish
-
Apr 2032
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 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) * ADDITIONAL EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY: * 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 * ADDITIONAL EXCLUSION CRITERIA FOR GROUP B (HIGH TUMOR BURDEN) ONLY: * Diagnosis of AML * Diagnosis of Burkitt's lymphoma * ADDITIONAL EXCLUSION CRITERIA FOR GROUP C (COMBINATION WITH CYCLOPHOSPHAMIDE) ONLY: * Diagnosis of AML * Diagnosis of Burkitt's lymphoma * ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY: * Diagnosis of AML * Diagnosis of AITL * ADDITIONAL EXCLUSION CRITERIA FOR GROUP F (BCL EXPANSION COHORT) ONLY: * Diagnosis of Burkitt's lymphoma * ADDITIONAL EXCLUSION CRITERIA FOR GROUP G (PTCL EXPANSION COHORT) ONLY: * Diagnosis of cutaneous TCL
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell non Hodgkin lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Mayo Clinic in Arizona
RECRUITINGScottsdale, Arizona, 85259, United States
Contact Email: •••••@•••••
-
Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Can adding linperlisib to standard chemotherapy improve outcomes in rare T-Cell lymphoma?
- Four-Drug combo aims to push High-Risk myeloma into deep remission
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Two-Drug combo targets tough Non-Hodgkin's lymphoma
- Can a drug and donor cells stop leukemia from returning after transplant?