Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma (NCT06508463) | Clinical Trial Compass
RecruitingPhase 1
Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
United States21 participantsStarted 2024-01-05
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 le…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding a safe dose of the vesicular stomatitis virus rather than proving it works, what does that mean for my chances of personally benefiting versus the risks I'd be taking on?
2The trial is specifically measuring serious side effects — grade 3 or higher adverse events — so what kinds of serious reactions have been seen with intravenous vesicular stomatitis virus in earlier research, and how would those be managed if they happened to me?
3My specific subtype — whether it's mycosis fungoides, anaplastic large cell lymphoma, or another peripheral T-cell lymphoma — might affect how I respond to this treatment, so would my diagnosis make me a particularly good or poor fit for what this trial is trying to learn?
4Are there approved or standard second-line treatments for my relapsed peripheral T-cell lymphoma that I should consider before enrolling in a Phase 1 virus-based study, and how does my doctor weigh those options against joining this trial now?
5Since this involves an intravenous viral therapy, what would the treatment schedule look like in terms of hospital visits, monitoring requirements, and any isolation precautions — and is that realistic given my current health and daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.