The Phase 1 trial (NCT03213964), which is currently recruiting participants, was designed to determine the maximum dose of a single FATE-NK100 infusion — the primary endpoint — in women with recurrent ovarian, fallopian tube, and primary peritoneal cancer.
The treatment is administered via an intraperitoneal catheter (a soft tube inserted into the abdomen) in patients who received prior platinum-based chemotherapy and are either platinum-resistant or platinum-sensitive.
Within 30 minutes of the FATE-NK100 infusion, patients receive a subcutaneous interleukin-2 (IL-2) injection at the medical center. The remaining IL-2 doses are given in an outpatient setting, three times a week for a total of six doses.
IL-2 is the only U.S. Food and Drug Administration (FDA)-approved therapy that promotes NK cell activation and survival. The therapy is sold under different brand names, including Proleukin and Aldesleukin.
Researchers will assess the safety of three different doses of FATE-NK100 — 10 million cells per kg body weight, between 10 and 30 million cells per kg, and up to 100 million cells per kg.
Secondary endpoints include objective response rate at 28 days, and progression-free and overall survival at six months after the FATE-NK100 infusion.
FATE-NK100 is an investigational cancer immunotherapy composed of donor-derived NK cells — key cells of the innate immune system — that have been activated in the lab for enhanced anti-tumor activity. The therapy uses a particular subset of NK that show a maturation marker called CD57.
In preclinical studies, FATE-NK100 showed broad anti-tumor action against both solid and liquid tumors. Also, compared to other currently-used NK cell therapies, FATE-NK100 proved better at overcoming tumor-evasion strategies, such as activation of immune checkpoint pathways.
“Women today often are treated with intraperitoneal chemotherapy, and the administration of FATE-NK100 directly within the peritoneal cavity is an exciting therapeutic strategy to restore NK cell function, promote persistence and inhibit tumor growth,” Melissa A. Geller, MD, the trial’s lead investigator at the Masonic Cancer Center, said in a press release.
“Ovarian cancer is a disease of middle-age women, and over 60 percent of women with ovarian cancer initially present with advanced disease,” added Geller, who is also an associate professor in the Division of Gynecologic Oncology at the University of Minnesota.
“For these women, the rate of recurrence is around 70 percent, and there is an urgent need for novel therapeutic strategies since standard treatments in the recurrent setting provide dismal response rates, especially in platinum-resistant disease,” she added.