A Phase 0 Pilot Study of Memory-like Natural Killer (NK) Cell Immune Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma
Dana-Farber Cancer Institute
Summary
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 low dose IL-2, 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) * IL-2 (a type of cytokine)
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 intende…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed, advanced or metastatic clear cell renal cell carcinoma, translocation renal cell carcinoma, chromophobe renal cell carcinoma, or urothelial carcinoma. The presence of rhabdoid or sarcomatoid differentiation is permitted if a clear cell or urothelial carcinoma component is also present. * Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by ches…
Interventions
- BiologicalCytokine Induced Memory-like Natural Killer (CIML NK) Cells
Autologous, cytokine induced memory-like natural killer cells, via intravenous (into the vein) infusion per protocol.
- DrugInterleukin-2 (IL-2)
Interleukin-2 (aldesleukin, IL-2) will be used to support natural killer cell proliferation and activity
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts