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Cellular Therapy

CIML NK Cells + N-803 for Ovarian Cancer

Phase 1

Recruiting

Led By Rebecca Porter, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of a combination therapy involving CIML NK cell therapy and N-803 in patients with recurrent, high grade ovarian cancer.

Who is the study for?

This trial is for individuals with high-grade ovarian cancer that has come back after treatment. Participants should have a certain level of physical fitness and adequate organ function. Specific details about who can or cannot participate are not provided here.

What is being tested?

The study is testing the combination of CIML NK cell therapy, which uses immune cells designed to remember and attack cancer, with N-803, an agent that boosts the immune system's response against ovarian cancer.

What are the potential side effects?

While specific side effects are not listed here, treatments like CIML NK cell therapy and IL-15 superagonists may cause flu-like symptoms, fatigue, allergic reactions, and could potentially overstimulate the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicity (DLT) (Cohort 1)

Maximum Tolerated Dose (MTD) (Cohort 1)

Secondary study objectives

6 months Progression Free Survival (PFS6)

Clinical Benefit Rate (CBR)

Duration of Response (DOR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Level 0Experimental Treatment2 Interventions

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.

Group II: Dose Level -1Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Interleukin 2

2014

Completed Phase 4

~330

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