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 weeks3 visits

Treatment ~ Varies

Follow Up ~ observation period up to 98 days.

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

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