← Back to Search

Cell Therapy

NK Cells + N-803 for Kidney and Bladder Cancer

Phase < 1
Recruiting
Led By Wenxin Xu, MD
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 observation period up to 98 days.
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test the safety and effectiveness of using a combination of special immune cells called CIML NK cells and a medication called N-803 to treat advanced clear cell renal cell carcinoma and uro

Who is the study for?
This trial is for adults with advanced renal cell carcinoma or urothelial carcinoma. Participants must have measurable disease and be able to provide a sample of their tumor tissue. They should not have had any other cancer treatments like chemotherapy, radiation, or surgery within the last 4 weeks.
What is being tested?
The study tests CIML NK cell therapy combined with N-803 in patients. CIML NK cells are immune cells treated to target cancer better, while N-803 boosts these cells' activity. The aim is to see if this combo is safe and how well it works against kidney and bladder cancers.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, flu-like symptoms such as fever and chills, fatigue, changes in blood pressure or heart rate, allergic reactions, and possible effects on normal organ functions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~observation period up to 98 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and observation period up to 98 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility Failure Rate (FFR)

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 0: CIML NK + low dose IL-2Experimental Treatment2 Interventions
Participants will be enrolled in a staggered fashion into a 3+3 dose de-escalation design per protocol to establish a maximum tolerated dose (MTD) of CIML NK Cells. Dose will start at Dose Level 0. * Baseline visit. * Day -7: Apheresis for autologous NK cell collection. * Days -6 through -2: Predetermined dose of standard of care lymphodepleting chemotherapy per protocol. * Days 0: Predetermined dose of CIML NK Cell Therapy infusion 1x daily administered in-clinic or hospital. * Days 1 through 8: Low dose IL-2 every other day * Day 28 and then ever 2-3 months: CT/MRI/PET * In-clinic visit every 3 months with CT, MRI, or PET scan. * End of Treatment: in-clinic visit * Follow Up: every 4 months in-clinic, by telephone, or remotely. * If 2 or more out of 5 participants experience dose-limiting toxicities (DLTs), subsequent dose will be de-escalated to Dose Level -1.
Group II: Dose Level -1: CIML NK + low dose IL-2Experimental Treatment2 Interventions
Participants will complete: * Baseline visit. * Day -7: Apheresis for autologous NK cell collection. * Days -6 through -2: Predetermined dose of standard of care lymphodepleting chemotherapy per protocol. * Days 0: Predetermined dose of CIML NK Cell Therapy infusion 1x daily administered in-clinic or hospital. * Days 1 to 8: low dose IL-2 every other day * Day 28 and then ever 2-3 months: CT/MRI/PET * In-clinic visit every 3 months with CT, MRI, or PET scan. * End of Treatment: in-clinic visit * Follow Up: every 4 months in-clinic, by phone, or remotely. * If 1 or less DLTs are observed, this will be the maximum tolerated dose. If 2 or more DLTs are observed, accrual will stop.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-2 (IL-2)
2017
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Kidney Cancer AssociationUNKNOWN
Dana-Farber Cancer InstituteLead Sponsor
1,107 Previous Clinical Trials
357,118 Total Patients Enrolled
ImmunityBio, Inc.Industry Sponsor
66 Previous Clinical Trials
4,754 Total Patients Enrolled
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top