Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318871
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-12
Brief Title:
Memory-like Natural Killer NK Cell Therapy in Patients with Renal Cell Carcinoma or Urothelial Carcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 0 Pilot Study of Memory-like Natural Killer NK Cell Immune Therapy in Patients with Renal Cell Carcinoma or Urothelial Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like CIML natural killer NK cells a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers combined with low dose IL-2 which is a cytokine that activates immune cells in advanced clear cell renal cell carcinoma and urothelial carcinoma
Names of the study therapies involved in this study areis
CIML NK cell therapy a NK cell therapy
IL-2 a type of cytokine
Names of the study therapies involved in this study areis
CIML NK cell therapy a NK cell therapy
IL-2 a type of cytokine
Detailed Description:
The purpose of this research study is to obtain information on the feasibility of CIML NK cell therapy with IL-2 to treat advanced clear cell renal cell carcinoma and urothelial carcinoma This is the first time that the specific combination of CIML NK cells and IL-2 will be given to humans
The US Food and Drug Administration FDA has not approved CIML NK cells post Maintenance Culture as a treatment for renal cell carcinoma or urothelial carcinoma
The FDA has approved IL-2 as a treatment for renal cell carcinoma but the dose used will be lower than the approved dose as IL-2 is intended to support the CIML NK cells
This research study involves screening for eligibility collection of natural killer NK cells in a process called leukapheresis treatment visits X-rays Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans blood tests urine tests echocardiograms electrocardiograms ECGs and tumor biopsies
Participants will be in this research study for up to 5 years from the CIML NK cell infusion
It is expected that about 5 people will take part in this research study
This research is supported by a grant from the Kidney Cancer Association
The US Food and Drug Administration FDA has not approved CIML NK cells post Maintenance Culture as a treatment for renal cell carcinoma or urothelial carcinoma
The FDA has approved IL-2 as a treatment for renal cell carcinoma but the dose used will be lower than the approved dose as IL-2 is intended to support the CIML NK cells
This research study involves screening for eligibility collection of natural killer NK cells in a process called leukapheresis treatment visits X-rays Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans blood tests urine tests echocardiograms electrocardiograms ECGs and tumor biopsies
Participants will be in this research study for up to 5 years from the CIML NK cell infusion
It is expected that about 5 people will take part in this research study
This research is supported by a grant from the Kidney Cancer Association
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None