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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06321484
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytokine-Induced Memory-like Natural Killer Cells — BIOLOGICAL
    Cytokine Induced Memory-like Natural Killer (CIML NK) Cells Autologous, cytokine induced memory-like natural killer cells, via intraperitoneal (IP) infusion per protocol.
  • Interleukin 2 — DRUG
    Low dose subcutaneous IL-2 will be administered every other day for 5 doses after CIML NK cell infusion

Study Details

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)

Key Dates

First listed
Mar 20, 2024
Start date
Oct 9, 2024
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Oct 31, 2031

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 0
    Participants will be enrolled in a staggered fashion into a 3+3 dose de-escalation per protocol to establish a maximum tolerated dose (MTD). Dosage will start at dose level 0. * Baseline visit. * MRIs, PET scans, and/or CT scans every 8 weeks. * Cycle 0: * Day -7 of 8 day cycle: Apheresis for autologous NK cell collection. * Days -6 through -2 of 8 day cycle: Predetermined dose of lymphodepleting chemotherapy per protocol. * Days -5 through -4 of 8 day cycle: * Predetermined dose of lymphodepleting chemotherapy per protocol. * Predetermined dose of premedication per institutional standards. * Day 0 of 8 day cycle: * Predetermined dose of CIML NK cells once * Subcutaneous low-dose IL-2 once * Cycle 1: \- Days 2-8: Subcutaneous low-dose IL-2 every other day for 4 additional doses * Off-Treatment: * Long-term follow up for 5 years after last CIML NK cell infusion.
  • Experimental: Dose Level -1
    3+3 de-escalation to dose level -1 per protocol if DLTs occur in Cohort 1 dose Level 0. * Baseline visit. * MRIs, PET scans, and/or CT scans every 8 weeks. * Cycle 0: * Day -7 of 8 day cycle: Apheresis for autologous NK cell collection. * Days -6 through -2 of 8 day cycle: Predetermined dose of lymphodepleting chemotherapy per protocol. * Days -5 through -4 of 8 day cycle: * Predetermined dose of lymphodepleting chemotherapy per protocol. * Predetermined dose of premedication per institutional standards. * Day 0 of 8 day cycle: * Predetermined dose of CIML NK cells once * Subcutaneous low-dose IL-2 once * Cycle 1: \- Days 2-8: Subcutaneous low-dose IL-2 every other day for 4 additional doses * Off-Treatment: * Long-term follow up for 5 years after last CIML NK cell infusion.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) (Cohort 1) [ Time Frame: 60 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Rebecca Porter, MD, PhD
[email protected]
617-632-2334
Rebecca Porter, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Rebecca Porter, MD, PhD
[email protected]
617-632-2334
Rebecca Porter, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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