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

Last updated: August 7, 2024
Sponsor: Radboud University Medical Center
Overall Status: Completed

Phase

1

Condition

Ovarian Cysts

Carcinoma

Treatment

UCB-NK cells

Chemotherapy

Clinical Study ID

NCT03539406
NL60937.000.17
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients suffering from their second recurrence of ovarian, fallopian tube orprimary peritoneal cancer, with an elevated serum level of CA-125 on two successivetime points with 28 days in between, reaching a value of more than 2 times nadir andabove 35 U/ml without gastrointestinal symptoms.

  • Able to undergo laparoscopic IP port placement and IP treatment administration

  • Adequate organ function

  • Age 18 years or older

  • Age under 76 years.

  • Karnofsky performance status >70% (see appendix 2)

  • Life expectancy > 6 months

  • At least 28 days after last anti cancer treatment, before start of preparativeregimen

  • Written informed consent

  • Availability of a partially HLA-matched UCB unit

Exclusion

Exclusion Criteria:

  • Patients on immunosuppressive drugs

  • Patients with active infections (viral, bacterial or fungal) that requires specifictherapy. Acute anti-infectious therapy must have been completed within 14 days priorto study treatment

  • Laparoscopic adhesion score >4 out of 9.

  • Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestiveheart failure or symptomatic ischemic heart disease (appendix 4)

  • Severe pulmonary dysfunction (CTCAE III-IV) (appendix 4)

  • Severe renal dysfunction (MDRD<50) (appendix 4)

  • Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level) (appendix 4)

  • Severe neurological or psychiatric disease

Study Design

Total Participants: 11
Treatment Group(s): 2
Primary Treatment: UCB-NK cells
Phase: 1
Study Start date:
June 04, 2019
Estimated Completion Date:
September 01, 2023

Study Description

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.

Connect with a study center

  • Radboudumc

    Nijmegen,
    Netherlands

    Site Not Available

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