Introduction/Background Median 5 year overall survival for patients with epithelial ovarian cancer(EOC) is poor. New therapeutic options are needed. Allogeneic natural killer (NK)-cell therapy may be such an option. NK cells are tolerant to normal cells, but have killing potential against malignant cells. Our GMP compliant NK-cell product (RNK001) from umbilical cord blood derived hematopoietic stem and progenitor cells is active against ovarian cancer cells in vitro and in vivo.

Methodology The INTRO-study (NCT03539406) is a phase-I clinical trial evaluating the feasibility, safety and toxicity of intraperitoneal (IP) infusion of RNK001 combined with IL2 without or with lymphodepletion by Fludarabine/Cyclophosphamide (Flu/Cy). EOC patients with rising CA-125 at second recurrence were eligible.

Results Six patients without Flu/Cy and 1 patient with Flu/Cy were treated with RNK001. The infusion of RNK001 and IL2 through a IP port is feasible. There were two serious adverse events in different patients: a grade 3 (CTCAE III-IV) rise of liver enzymes, and a grade 3 ileus. After one week we detected 0.24 and 1.02% donor NK cells in the peritoneal fluid of two patients. In 5/7 patients, CA-125 serum levels decreased by 20–53% at day 14 after RNK001 from baseline. One patient had a partial response (according to RECIST) with a progression-free survival (PFS) of 9 months (median PFS of all patients was 3 months).

Conclusion We have shown the feasibility and safety of intraperitoneal infusion of in seven patients. We found a transient decline in CA-125 levels and one patient with a partial response and a PFS of 9 months. Flu/Cy in patients with second recurrence was not feasible due to refusal of the patients. We will continue clinical research with a phase 2 study investigating RNK001 intraperitoneal infusion combined with carboplatin paclitaxel.

Disclosures Authors have nothing to disclose.