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Cellular Therapy

Dose Level 0 for Ovarian Cancer

Phase 1

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity (DLT) (Cohort 1)

Maximum Tolerated Dose (MTD) (Cohort 1)

Secondary outcome measures

6 months Progression Free Survival (PFS6)

Clinical Benefit Rate (CBR)

Duration of Response (DOR)

+2 more

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. Cycle 1: - Days 1, 8 and 15 of 21-day cycle: Predetermined dose of N-803 1x weekly. Cycle 2 - End of Treatment - Predetermined dose of N-803 1x every 3 weeks until disease progression. 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. Cycle 1: - Days 1, 8 and 15 of 21-day cycle: Predetermined dose of N-803 1x weekly. Cycle 2 - End of Treatment - Predetermined dose of N-803 1x every 3 weeks until disease progression. Off-Treatment: Long-term follow up for 5 years after last CIML NK cell infusion.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,930 Total Patients Enrolled

39 Trials studying Ovarian Cancer

4,512 Patients Enrolled for Ovarian Cancer

ImmunityBio, Inc.Industry Sponsor

63 Previous Clinical Trials

5,118 Total Patients Enrolled

1 Trials studying Ovarian Cancer

Rebecca Porter, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

35 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participation in this clinical study?

"Individuals aged between 18 and 85 with a confirmed diagnosis of ovarian cancer are eligible for enrollment in this research. A total of 18 participants will be sought for the study."

Answered by AI

Is the enrollment for this medical study currently open?

"Per information on clinicaltrials.gov, the current status of this research project is not open for participant enrollment. The trial was first listed on May 1st, 2024 and most recently revised on March 13th, 2024. Presently, there are a total of 3882 ongoing trials actively seeking individuals to participate."

Answered by AI

What is the safety profile of Dose Level 0 in individuals receiving treatment?

"According to our evaluation at Power, Dose Level 0 was rated as a safety score of 1 on the scale from 1 to 3. This determination is based on the early Phase 1 trial status, indicating scarce data supporting both safety and efficacy."

Answered by AI

Is there an age restriction for potential participants under 50 years old in this research trial?

"As per the trial's eligibility criteria, individuals aged 18 to 85 are eligible for enrollment in this clinical study."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary objective within this study, to be assessed over a 60-day period, is determining the Maximum Tolerated Dose (MTD) in Cohort 1. Secondary endpoints include evaluating the 6-month Progression-Free Survival (PFS6), which quantifies the proportion of patients who survive without disease progression at the half-year mark using Kaplan-Meier analysis. Additionally, Median Progression-Free Survival (PFS) will be examined employing Kaplan-Meier statistics to determine time from registration until either disease advancement or mortality irrespective of cause; participants demonstrating no progression are censored at their last evaluation. Lastly, Duration of"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Rebecca Porter, MD, PhD 2024. "Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06321484.

All > Recurrent Ovarian Cancer