Trials / Recruiting
RecruitingNCT06508463
Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 ipilimumab and 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.
Detailed description
PRIMARY OBJECTIVE: To determine the maximum tolerated dose (MTD) of VSV-hIFNβ-NIS in combination with ipilimumab and cemiplimab in patients with T-cell lymphoma \[Group E\]. Patients undergo computed tomography (CT) scan, position emission tomography (PET) scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study. After completion of study treatment, patients are followed up for 28 days, and then every 3 months for up to 1 year or until progressive disease, then every 6 months for 1 year.
Conditions
- Peripheral T Cell Lymphoma
- Relapsed Peripheral T-Cell Lymphoma
- Peripheral T-Cell Lymphoma, Not Otherwise Specified
- Anaplastic Large Cell Lymphoma
- Mycosis Fungoides
- Relapsed Anaplastic Large Cell Lymphoma
- Relapsed Mycosis Fungoides
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biopsy | Undergo tumor biopsy |
| PROCEDURE | Biospecimen Collection | Undergo blood sample collection |
| PROCEDURE | Bone Marrow Biopsy | Undergo bone marrow biopsy |
| PROCEDURE | Computed Tomography | Undergo SPECT/CT |
| PROCEDURE | Positron Emission Tomography | Undergo PET scan |
| BIOLOGICAL | Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter | Given IV |
| PROCEDURE | Single Photon Emission Computed Tomography | Undergo SPECT/CT |
| BIOLOGICAL | Cemiplimab | Given IV |
| BIOLOGICAL | Ipilimumab | Given IV |
Timeline
- Start date
- 2024-01-05
- Primary completion
- 2028-12-31
- Completion
- 2032-04-01
- First posted
- 2024-07-18
- Last updated
- 2026-04-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06508463. Inclusion in this directory is not an endorsement.