Intraperitoneal infusion of ex vivo cultured allogeneic Natural Killer cells in recurrent ovarian carcinoma patients.

Intraperitoneal infusion of ex vivo cultured allogeneic Natural Killer cells in recurrent ovarian carcinoma patients. - INTRO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45699

Enrollment

Registered

2017-06-07

Start date

2019-06-07

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian carcinoma

Interventions

Intraperitoneal UCB-NK cell infusion of UCB-NK cells in combination with IL-2 support, with versus without a preceding lymphodepleting conditioning regimen.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient with a second recurrence of ovarian cancer, based on increasing CA-125 levels, without symptoms. Patients are included after palliative chemotherapy for their first recurrence. Patients must have a life expectancy of >6 months and are only enrolled after prior given written informed consent. Patients should be able to undergo a laparoscopy.

Exclusion criteria

Exclusion criteria: Patients with active infections or serious organ failure are excluded. Patients on immunesuppressive drugs and with recent chemotherapy (

Design outcomes

Primary

Measure	Time frame
Safety and toxicity of intraperitoneal UCB-NK cell infusion in combination with IL-2 support, with versus without a preceding lymphodepleting conditioning regimen	—

Secondary

Measure	Time frame
Secondary objectives are in vivo lifespan, proliferation and functional activity of infused NK cells and preliminary effect on peritoneal disease using CA-125 serum levels.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)