This is a Phase I trial to determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following minimal prior treatment requirement: * Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy). Platinum resistant is defined as disease that has responded to initial chemotherapy but demonstrates recurrence within a relatively short period of time (\< 6 months) following the completion of treatment. * Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy). Platinum sensitive is defined as the recurrence of active disease in a patient who has achieved a documented response to initial platinum-based treatment and has been off therapy for an extended period of time (≥ 6 months).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
FATE-NK100 Infusion (Day 0) The FATE-NK100 product will be placed in approximately 100 cc of 5% human serum albumin. * Dose Level 1: 1 x 10\^7 cells/kg IP * Dose Level 2: \>1x10\^7 cells/kg to ≤3x10\^7 cells/kg * Dose Level 3: Complete FATE-NK100 bag (≥3 x 10\^7 to ≤ 10 x 10\^7 cells/kg)
Interleukin-2 (begin Day 0): 6 million units three times a week for a total of 6 doses. For patients weighing less than 45 kilograms, the IL-2 will be given at 3 million units/m2 three times a week for 6 doses. The 1st dose will be given immediately (within 30 minutes) after the FATE-NK100 cell infusion on Day 0 as an inpatient. The remaining doses will be given in an outpatient setting.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Maximum Tolerated Doze of FATE-NK100
To determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of FATE-NK100 when administered via intraperitoneal catheter in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.
Time frame: 1 Year
Objective Response Rate
Incidence of objective response rate (ORR) of the FATE-NK100 treatment
Time frame: Day 28
Progression-Free Survival (PFS)
Incidence of progression-free survival of treated patients 6 months post-infusion
Time frame: 6 Months
Overall Survival (OS)
Incidence of overall survival of treated patients 6 months post-infusion
Time frame: 6 Months
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