A Phase 1 interventional study of UCB-NK cells and Chemotherapy in Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma and Recurrent Primary Peritoneal Carcinoma, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Radboud University Medical Center · Phase 1, Interventional, and Treatment
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.
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.
This study is a phase I safety and feasibility study in a series of 12 patients who are suffering from recurrent ovarian, fallopian tube or primary peritoneal cancer. Prior to NK cell infusion, a laparoscopy is performed to place a catheter in the peritoneal cavity. The first cohort of three patients will receive an intraperitoneal infusion of allogeneic UCB-NK cells generated ex vivo from CD34+ hematopoietic progenitor cells obtained from an allogeneic UCB unit without a preparative regimen. In the second group of three patients the same UCB-NK cell dosage will be given with a preparative regimen of four days non-myeloablative immunosuppressive conditioning regimen with cyclophosphamide and fludarabine (CyFlu). If no severe toxicity is seen in these 6 patients, an extension cohort of 6 patients will be included to answer the secondary objective.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 11 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
NK-cells without preparative regimen
Biological: UCB-NK cells
NK-cells with preparative regimen
Biological: UCB-NK cells · Drug: Chemotherapy
Intraperitoneal allogeneic UCB-NK cells infusion
Cyclofosfamide/fludarabine treatment
Incidence of treatment emergent adverse events
Incidence of treatment emergent adverse events (following CTCAE criteria)
Time frame: 6 months
in vivo lifespan of the infused UCB-NK cells
determination of NK cell percentage in blood and peritoneal fluid
Time frame: 28 days
in vivo expansion of the infused UCB-NK cells
determination of NK cell percentage in peritoneal fluid and blood
Time frame: 28 days
Measurement of in vitro cytolytic activity of infused NK cells
in CFSE base killing assays a percentage of dead cells (K562 cells) will be measured.
Time frame: 28 days
the effect of NK cell infusion on measurable disease
CA-125 testing in blood (in E/mL)
Time frame: 6 months
the effect of NK cell infusion on measurable disease
CT-scan (measurement of visible leasions in cm)
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center