Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients

Phase 1 Completed 11 enrolled Radboud University Medical Center Dutch Cancer Society · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex vivo-generated allogeneic natural killer (NK) cells with or without preceding non-myeloablative conditioning chemotherapy.

Timeline

Start: 2019-06-04
Primary completion: 2023-05-01
Completion: 2023-09-01

Publications

Hoogstad-van Evert JS, de Jonge PKJD, Zusterzeel PLM, Hobo W, van der Waart AB, Fredrix H, Janssen L, Wuts M, Bosmans L, Spijkers E, Djojoatmo M, Rodriguez VC, de Goede AL, van der Reijden B, van der Meer A, Schaap N, Bekkers R, Jansen JH, Ottevanger N, Dolstra H. Intraperitoneal infusion of stem cell-derived natural killer cells in recurrent epithelial ovarian cancer patients: Results of the phase 1 INTRO-01 trial. Gynecol Oncol. 2026 Jan;204:91-99. doi: 10.1016/j.ygyno.2025.11.006. Epub 2025 Nov 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RNK001	Unknown	1.2e+09 cells	Intrathecal
Subject	RNK001	Unknown	3e+09 cells	Intrathecal
Background	Cyclophosphamide	Other / unclassified	—	—
Background	Fludarabine	Small molecule	—	—

Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients

Summary

Timeline

Publications

Drugs

Indications