Clinical activity of single-dose systemic oncolytic VSV virotherapy in patients with relapsed refractory T-cell lymphoma.
Joselle Cook, Kah-Whye Peng, Thomas E Witzig...
https://pubmed.ncbi.nlm.nih.gov/35175355Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID03017820
Phase I Trial of Vesicular Stomatitis Virus Vaccine Expressing NIS and Human Interferon Beta in Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, and Lymphomas
Led by Mayo Clinic · Updated on 2026-05-28
99
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the best dose and side effects of a vaccine called VSV-hIFNβ-NIS, given alone or combined with cyclophosphamide and immunotherapy drugs ipilimumab, nivolumab, and cemiplimab. This phase I trial focuses on patients with relapsed or refractory multiple myeloma, acute myeloid leukemia, or types of lymphoma. The vaccine is a modified virus designed to target cancer cells while protecting normal cells using interferon beta, and the study aims to find safe and effective treatment combinations for these blood cancers. Participants are assigned to different groups receiving various combinations of the vaccine and other drugs, such as cyclophosphamide intravenously or immunotherapy antibodies intravenously. Treatments are given mostly by intravenous infusion on specific days, with some oral medications taken over several days. Some groups are closed to new enrollment, while others continue with dose escalation or expansion. Patients undergo imaging scans like PET/CT and biopsies of tumors or bone marrow to monitor disease and treatment effects. Throughout the study, participants visit regularly for follow-up assessments, including blood tests, biopsies, and imaging to track viral spread, immune response, and treatment safety. Follow-up occurs on days 15 and 29, at 6 weeks, then every 3 months up to 1 year or until disease progression, followed by every 6 months until 2 years after enrollment. The main measurement is the frequency of serious side effects over two years, alongside tumor response, progression-free survival, and overall survival.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Relapsed or refractory disease including multiple myeloma previously treated with specified drugs
- Relapsed peripheral T-cell lymphoma with failed or ineligible for high-dose therapy
- B-cell lymphoma or histiocytic/dendritic cell neoplasms at any stage (selected groups)
- Measurable disease by specific criteria depending on cancer type
- Adequate liver and kidney function within 15 days prior to registration
- Required blood counts and hemoglobin levels depending on disease type
- No active central nervous system involvement
- Ability to provide informed consent and willingness to follow up
- Life expectancy of at least 12 weeks
- ECOG performance status 0, 1, or 2
- Willingness to provide biological specimens for research
You will not qualify if you...
- Availability of and acceptance of curative therapy
- Uncontrolled infection or active tuberculosis or hepatitis
- Recent chemotherapy or immunotherapy within specified timeframes
- New York Heart Association class III or IV or known symptomatic coronary artery disease or arrhythmias
- Active central nervous system disorder or seizure disorder
- HIV positive or other immunodeficiency
- Concurrent investigational chemotherapy, immunotherapy, or radiotherapy
- Pregnant or nursing women or unwillingness to use contraception
- Current disseminated intravascular coagulation for AML
- Additional exclusions based on specific treatment groups including certain lymphoma diagnoses and hypersensitivity to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 days of treatment drugs administration
Participants receive the VSV-hIFNβ-NIS vaccine intravenously on day 1, with additional drugs depending on their assigned group, including ruxolitinib, cyclophosphamide, ipilimumab, nivolumab, or cemiplimab. Treatment occurs in the absence of disease progression or unacceptable toxicity. Participants also undergo various biopsies and imaging scans during this period.
1 to 2 visits during treatment period depending on group assignment
Follow-up
Duration - Up to 2 years
Participants are followed up after treatment on days 15 and 29, at 6 weeks, then every 3 months until 1 year or until disease progression, whichever is longer, followed by every 6 months until 2 years after registration. During follow-up, participants undergo assessments to monitor safety, disease progression, and survival.
Multiple visits: days 15 and 29, 6 weeks, every 3 months up to 1 year, then every 6 months up to 2 years
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
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Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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Published Research Related To This Trial
Nodal peripheral T-cell lymphoma: Chemotherapy-free management, are we there yet?
Sharina C Macapagal, N Nora Bennani
https://pubmed.ncbi.nlm.nih.gov/36898933