This phase I trial studies the side effects and the best dose of allogeneic CD3- CD19- CD57+ NKG2C+ NK cells FATE-NK100 (FATE-NK100) when given together with aldesleukin after fludarabine and cyclophosphamide in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FATE-NK100, which is made from cells collected from the blood of a relative who is considered a “donor”, may enhance anti-tumor activity. Aldesleukin may stimulate white blood cells including natural killer cells to kill tumor cells. Giving fludarabine, cyclophosphamide, FATE-NK100, and aldesleukin may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03213964.
PRIMARY OBJECTIVES:
I. 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.
SECONDARY OBJECTIVES:
I. To assess the objective response rate (ORR) of this treatment 28 days after the infusion of the FATE-NK100.
II. To estimate progression-free survival (PFS) and overall survival (OS) at 6 months post-infusion.
TERTIARY OBJECTIVES:
I. To determine the proportion of patients with FATE-NK100 expansion within the peritoneum.
II. To assess whether FATE-NK100 is present in the blood and peritoneum.
III. To quantify the number of cells of FATE-NK100 in the blood and peritoneum.
IV. To measure function of in vivo expanded adoptively transferred FATE-NK100.
V. To correlate disease response with in vivo expansion of FATE-NK100.
OUTLINE: This is dose-escalation study of FATE-NK100.
Patient receive fludarabine intravenously (IV) over 1 hour and cyclophosphamide IV over 2 hours on days -6 and -5. Patients receive FATE-NK100 intraperitonealy (IP) and within 30 minutes, patients receive aldesleukin IP on day 0. Patients then continue to receive aldesleukin IP on days 2, 5, 7, 9, and 12.
After completion of study treatment, patients are followed up every 3 months for up to 12 months.
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorMelissa A. Geller