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 in recurrent, high grade ovarian cancer (HGOC). Names of the study therapies involved in this study are: CIML NK (cellular therapy) Interleukin-2 (IL-2)
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 in recurrent, high grade ovarian cancer. Participants will be enrolled to test the safety of intraperitoneal CIML NK cell therapy The U.S. Food and Drug Administration (FDA) has not approved CIML NK cell therapy 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 low-dose IL-2, 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Cytokine Induced Memory-like Natural Killer (CIML NK) Cells Autologous, cytokine induced memory-like natural killer cells, via intraperitoneal (IP) infusion per protocol.
Low dose subcutaneous IL-2 will be administered every other day for 5 doses after CIML NK cell infusion
Brigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMaximum Tolerated Dose (MTD) (Cohort 1)
The MTD of the use of cytokine induced memory-like natural killer (CIML NK) cell therapy is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for DLT definition.
Time frame: 60 days
Dose Limiting Toxicity (DLT) (Cohort 1)
A DLT is defined as an adverse event that is related to CIML NK cell therapy with an attribution of possible, probable, or definite, and meets the criteria defined in protocol section 5.4.
Time frame: 60 days
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who achieved partial response or complete response during study treatment based on RECIST 1.1 and immune-related RECIST criteria.
Time frame: Up to 5 years
Median Progression Free Survival (PFS)
PFS is defined as the time from registration to the earlier of progression (PD) or death due to any cause based on Kaplan-Meier methodology. Participants alive without disease progression are censored at date of last disease evaluation.
Time frame: Up to 5 years
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants who achieved a complete response, partial response, or had stable disease for 6 months or more based on RECIST 1.1 and immune-related RECIST criteria.
Time frame: Up to 5 years
Duration of Response (DOR)
DOR is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first data that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation.
Time frame: Up to 5 years
6 months Progression Free Survival (PFS6)
PFS6 is the percent probability estimate at 6 months based on the Kaplan-Meier method. PFS is defined as the time from registration to the earlier of progression (PD) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
Time frame: 6 months
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