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New treatment option for Peripheral T Cell Lymphoma
Official title Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
ClinicalTrials.gov ID: NCT06508463
What this study is testing
What is Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter?
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peripheral t cell lymphoma.
Also referred to as Oncolytic VSV-hIFNbeta-NIS, Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2 times upper limit of normal (ULN) (obtained =\< 15 days prior to...
- Creatinine =\< 2.0 mg/dL (obtained =\< 15 days prior to registration)
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
- ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:
- Diagnosis of AML
- Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.