Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 18 and up

Using a modified virus to treat patients with T-cell lymphoma

Official title: MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms

Run by Mayo Clinic · NCT06508463 · Data updated 2026-11-12

This study is testing a modified virus combined with immunotherapy to see if it can safely treat patients with different types of T-cell lymphoma.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment21 (estimated)
SponsorMayo Clinic
Academic / other
Drugs / interventionsCEMIPLIMAB, Chemotherapy, Immunotherapy, ipilmumab
Locations2 sites (Scottsdale, Arizona and 1 other locations)
StatusRecruiting
StartedJanuary 5, 2024
Main results expectedDecember 31, 2028
Study endsApril 1, 2032
Registry record updatedJuly 1, 2026
Trial IDNCT06508463 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with relapsed peripheral T-cell lymphoma or specific histologies such as anaplastic large cell lymphoma and mycosis fungoides.

Probably not a fit

Patients with active liver disease beyond Child Pugh class A or those with other significant comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I trial investigates the safety and optimal dosage of a modified vesicular stomatitis virus (VSV-hIFNβ-NIS) combined with immunotherapy agents ipilimumab and cemiplimab in patients with various forms of T-cell lymphoma. The study aims to determine the maximum tolerated dose while monitoring side effects and assessing the virus's ability to selectively target and kill cancer cells. Patients will undergo imaging scans and may have biopsies to evaluate treatment response throughout the study. Follow-up will occur for up to one year after treatment completion to monitor for disease progression.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with relapsed or refractory T-cell lymphoma.

How similar studies have gone: While the use of oncolytic viruses in cancer treatment is an emerging field, this specific combination of VSV with immunotherapy is novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Mayo Clinic in Arizona
    Scottsdale, Arizona, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Non-Hodgkin Lymphoma Sample Collection for MRD Testing

    This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.

    Recruiting Natera, Inc. · Austin, Texas · NCT07750886

  • Treatment of relapsed or refractory peripheral T-cell lymphoma with Chidamide and Duvalisib

    This study is testing if a new combination of two drugs, Chidamide and Duvalisib, can help people with hard-to-treat peripheral T-cell lymphoma feel better and live longer.

    Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT06151106

  • Registry for individuals with T-cell lymphoma

    This study is gathering information from people with T-cell lymphoma to help researchers learn more about the disease and improve treatments.

    Recruiting at 6 sites Memorial Sloan Kettering Cancer Center · Duarte, California and 25 other locations · NCT05978141

  • Testing a new treatment for relapsed T-cell non-Hodgkin lymphoma

    This study is testing a new treatment called ST-001 to see if it can help people with relapsed T-cell non-Hodgkin lymphoma feel better and have fewer side effects.

    Recruiting at 10 sites Phase 1 SciTech Development, Inc. · Scottsdale, Arizona and 9 other locations · NCT04234048

  • XNW5004 with CHOP/CHOEP in Untreated Peripheral T-Cell Lymphoma

    This study tests XNW5004 together with CHOP or CHOEP in adults with newly diagnosed peripheral T-cell lymphoma to see if the combination is safe and active.

    Recruiting Phase 1/2 Evopoint Biosciences Inc. · Shanghai, Shanghai Municipality · NCT07730515

  • Adaptive dual-target CAR-T therapy for relapsed or refractory blood cancers

    This trial will test whether matching a patient's cancer markers to one of several dual-target CAR-T therapies can work and be safe for adults whose blood cancer has come back or not responded.

    Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07523555

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.