Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321484
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-10-30
Brief Title:
Intraperitoneal Cytokine-Induced Memory Like CIML Natural Killer NK Cells in Recurrent Ovarian Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 1b Study of Cytokine-Induced Memory Like CIML Natural Killer NK Cell Therapy in Combination With N-803 Il-15 Superagonist in Recurrent Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 evaluate the safety and effectiveness of the use of cytokine-induced memory-like CIML natural killer NK cell therapy combined with IL-15 superagonist N-803 in recurrent high grade ovarian cancer HGOC
Names of the study therapies involved in this study are
CIML NK cellular therapy
N-803 a novel immune-cell stimulator
Names of the study therapies involved in this study are
CIML NK cellular therapy
N-803 a novel immune-cell stimulator
Detailed Description:
This is an open-label single site phase 1b study to evaluate the safety and effectiveness of the use of cytokine-induced memory-like CIML natural killer NK cell therapy combined with IL-15 superagonist N-803 in recurrent high grade ovarian cancer
Participants will be enrolled to test the safety of CIML NK cell therapy with N-803
The US Food and Drug Administration FDA has not approved CIML NK cell therapy as a treatment for recurrent high grade ovarian cancer
The FDA has not approved N-803 IL-15 superagonist as a treatment for recurrent high grade ovarian cancer
The research study procedures include screening for eligibility collection of natural killer NK cells in a process called leukapheresis lymphodepleting chemotherapy infusion of CIML NK cell therapy into the abdominal cavity intraperitoneal administration of immunotherapy study drug N-803 Computerized Tomography CT scans Magnetic Resonance Imaging MRI or Positron Emission Tomography PET scans blood tests urine tests electrocardiograms ECGs and echocardiograms
Participants in this research study will be followed for up to for 5 years after start of study treatment
It is expected that about 12-18 people will take part in this research study
The PHASE ONE Foundation Community Research Grant is providing funding for this research study Immunity Bio is supporting this study by providing N-803
Participants will be enrolled to test the safety of CIML NK cell therapy with N-803
The US Food and Drug Administration FDA has not approved CIML NK cell therapy as a treatment for recurrent high grade ovarian cancer
The FDA has not approved N-803 IL-15 superagonist as a treatment for recurrent high grade ovarian cancer
The research study procedures include screening for eligibility collection of natural killer NK cells in a process called leukapheresis lymphodepleting chemotherapy infusion of CIML NK cell therapy into the abdominal cavity intraperitoneal administration of immunotherapy study drug N-803 Computerized Tomography CT scans Magnetic Resonance Imaging MRI or Positron Emission Tomography PET scans blood tests urine tests electrocardiograms ECGs and echocardiograms
Participants in this research study will be followed for up to for 5 years after start of study treatment
It is expected that about 12-18 people will take part in this research study
The PHASE ONE Foundation Community Research Grant is providing funding for this research study Immunity Bio is supporting this study by providing N-803
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