Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508463
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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 HistiocyticDendritic Cell Neoplasms
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None