Memory-like Natural Killer (NK) Cell Therapy in Patients With Renal Cell Carcinoma or Urothelial … (NCT06318871) | Clinical Trial Compass
RecruitingEarly Phase 1
Memory-like Natural Killer (NK) Cell Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma
United States10 participantsStarted 2024-08-28
Plain-language 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)
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.
* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of CIML NK cells in participants \<18 years of age, children are excluded from this study, but would be eligible for future pediatric trials.
* Participants with clear cell RCC or UC must have progression after prior treatment failure with at least one PD-1/PD-L1 immune checkpoint inhibitor that is FDA approved for treatment of UC or RCC as of the date of informed consent.
* Patients with renal cell carcinoma should also have prior treatment failure with at least one prior VEGFR TKI, or contraindication to VEGFR TKIs as determined by the treating clinician. Patients with urothelial carcinoma should have either prior treatment failure with…