Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorDana-Farber Cancer Institute

About this trial

The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy in recurrent, high grade ovarian cancer (HGOC).

Names of the study therapies involved in this study are:

CIML NK (cellular therapy) Interleukin-2 (IL-2)

Eligibility criteria

Qualifiers

Participants must have histologically or cytologically confirmed recurrent epithelial ovarian cancer. Eligible histologies include high grade serous, high grade endometrioid and clear cell ovarian carcinoma.

Participants must have measurable cancer defined by RECIST 1.1 criteria.

Patients must have received at least 1 lines of prior systemic therapy and be deemed platinum resistant/intolerant by their treating oncologist. Patients with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment. Prior receipt of immune checkpoint blockade is allowed if grade 3 or higher toxicities were not experienced.

Age ≥18 years and <85 years old.

Disqualifiers

Participants who have had anti-tumor chemotherapy or other investigational agents within two weeks prior to NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 6 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior.

Participants with a bowel obstruction within the last 3 months or high risk for bowel obstruction (in the opinion of the investigator) or current need for parenteral nutrition or dependence on intravenous fluids.

Participants who are receiving any other investigational agents.

Solid organ transplant (allograft) recipients.

Trial design

Treatments tested in this trial

  • Cytokine-Induced Memory-like Natural Killer Cells
  • Interleukin 2

Treatment groups

18 Participants
are divided into 2 treatment groups

Sponsors and collaborators