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)
Participants must have histologically or cytologically confirmed recurrent epithelial ovarian cancer. Eligible histologies include high grade serous, high grade endometrioid and clear cell ovarian carcinoma.
Participants must have measurable cancer defined by RECIST 1.1 criteria.
Patients must have received at least 1 lines of prior systemic therapy and be deemed platinum resistant/intolerant by their treating oncologist. Patients with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment. Prior receipt of immune checkpoint blockade is allowed if grade 3 or higher toxicities were not experienced.
Age ≥18 years and <85 years old.
Participants who have had anti-tumor chemotherapy or other investigational agents within two weeks prior to NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 6 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior.
Participants with a bowel obstruction within the last 3 months or high risk for bowel obstruction (in the opinion of the investigator) or current need for parenteral nutrition or dependence on intravenous fluids.
Participants who are receiving any other investigational agents.
Solid organ transplant (allograft) recipients.
Sequential
Cytokine-Induced Memory-like Natural Killer Cells
Biological/VaccineCytokine Induced Memory-like Natural Killer (CIML NK) Cells Autologous, cytokine induced memory-like natural killer cells, via intraperitoneal (IP) infusion per protocol.
Interleukin 2
DrugLow dose subcutaneous IL-2 will be administered every other day for 5 doses after CIML NK cell infusion
Maximum 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.
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.
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.
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.
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.
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.
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