Memory-like Natural Killer (NK) Cell Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma

Description

The purpose of this research study is to obtain information on the feasibility of CIML NK cell therapy with IL-2 to treat advanced clear cell renal cell carcinoma and urothelial carcinoma. This is the first time that the specific combination of CIML NK cells and IL-2 will be given to humans.

The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells post Maintenance Culture as a treatment for renal cell carcinoma or urothelial carcinoma.

The FDA has approved IL-2 as a treatment for renal cell carcinoma but the dose used will be lower than the approved dose, as IL-2 is intended to support the CIML NK cells.

This research study involves screening for eligibility, collection of natural killer (NK) cells in a process called leukapheresis, treatment visits, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, urine tests, echocardiograms, electrocardiograms (ECGs), and tumor biopsies.

Participants will be in this research study for up to 5 years from the CIML NK cell infusion.

It is expected that about 10 people will take part in this research study.

This research is supported by a grant from the Kidney Cancer Association.