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Cytokine-Induced Memory-like Natural Killer Cells

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

  • RegistryNCT06321484
  • PhasePhase 1
  • StatusRecruiting
  • ConditionPlatinum-resistant Ovarian Cancer
  • SponsorDana-Farber Cancer Institute
How Intraperitoneal Cytokine-Induced Memory L… works1 min

The drug

What is being tested.

Cytokine Induced Memory-like Natural Killer (CIML NK) Cells Autologous, cytokine induced memory-like natural killer cells, via intraperitoneal (IP) infusion per protocol.

Low dose subcutaneous IL-2 will be administered every other day for 5 doses after CIML NK cell infusion

This is an open-label, single site, phase 1b study 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. Participants will be enrolled to test the safety of intraperitoneal CIML NK cell therapy The U.S. Food and Drug Administration (FDA) has not approved CIML NK cell therapy as a treatment for recurrent, high grade ovarian cancer.

The study

How the trial runs.

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)

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • 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.
  • ECOG performance status of 0 or 1.
  • Participants must meet the following organ and marrow function as defined below:

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

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