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

Start date
Oct 9, 2024
Status verified
Mar 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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