Virus-Immunotherapy combo targets Hard-to-Treat lymphoma
NCT ID NCT06508463
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This early-phase trial tests a genetically modified virus (VSV-hIFNβ-NIS) combined with an immunotherapy drug (cemiplimab) in adults with relapsed or refractory T-cell lymphoma. The virus is designed to kill cancer cells while leaving healthy cells alone, and the immunotherapy helps the immune system attack the tumor. The main goal is to find the best dose and understand side effects. About 21 participants will be enrolled.
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 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- 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: * 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 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 * 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 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 \[atrial fibrillation or supraventricular tachycardia (SVT)\] * 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 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anaplastic large cell 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 adding linperlisib to standard chemotherapy improve outcomes in rare T-Cell lymphoma?
- Pairing a steroid with lymphoma gel may prevent painful skin reactions
- Can a daily mood diary reveal how steroids affect emotions?
- Can blood and skin markers predict lymphoma outcomes?
- Can an eczema cream fight a rare skin cancer?
- Can a powerful combo of drugs and stem cell transplant beat tough lymphomas in kids?