Intraperitoneal infusion of stem cell-derived natural killer cells in recurrent epithelial ovarian cancer patients: Results of the phase 1 INTRO-01 trial
Epithelial ovarian cancer (EOC) patients exhibit a poor 5-year overall survival rate of approximately 40 %, underscoring the urgent need for innovative therapies. Allogeneic natural killer (NK) cell therapy presents a promising and safe therapeutic option, given its ability to discriminate between normal and malignant cells with potent cytotoxic effects against malignant cells. We present the first-in-human study exploiting the safety of the NK cell product designated RNK001, derived ex vivo from umbilical cord blood-derived hematopoietic stem and progenitor cells. This phase 1 INTRO-01 trial (NCT03539406) was initiated to assess the feasibility, safety, and toxicity of intraperitoneal (IP) infusion of RNK001 in EOC patients exhibiting elevated CA125 levels at the second recurrence. RNK001 infusion was supported by IP IL-2 in six patients, and was preceded in one patient by lymphodepleting chemotherapy with cyclophosphamide/fludarabine. RNK001 consisted of 1.2 to 3.0 × 10 These findings suggest that intraperitoneal RNK001-based immunotherapy can be safely administered to recurrent EOC patients without inducing severe toxicity, while clinical and biochemical responses warrant further development.