Renal Cell Carcinoma Clinical Trial
Official title:
A Phase 0 Pilot Study of Memory-like Natural Killer (NK) Cell Immune Therapy in Combination With N-803 in Patients With Renal Cell Carcinoma or Urothelial Carcinoma
The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like (CIML) natural killer (NK) cells, a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers, combined with N-803, a medication that increases the activity of Interleukin-15, which is a cytokine that activates immune cells, in advanced clear cell renal cell carcinoma and urothelial carcinoma. Names of the study therapies involved in this study are/is: - CIML NK cell therapy (a NK cell therapy) - N-803 (a type of recombinant human IL-15 superagonist)
The purpose of this research study is to obtain information on the feasibility of the combination of CIML NK cell therapy with N-803 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 NIZ803 (IL-15 superagonist) 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 not approved N-803 as a treatment for renal cell carcinoma or urothelial carcinoma. 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 5 people will take part in this research study. This research is supported by a grant from the Kidney Cancer Association. ImmunityBio is supporting this research by providing the N-803 medication. ;
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