T cell therapy is an experimental personalized immunotherapy where tumor-infiltrating lymphocytes are isolated from the patient's own tumor tissue, expanded in vitro to billions of cells and then administered to the individual patient with the purpose of eliminating the remaining cancer cells. In malignant melanoma, the treatment has had a profound clinical effect in 50% of patients of which 20% seems to be cured. Recent studies suggest that T-cell therapy might work in other types of cancer, including renal cell carcinoma (RCC).
A clinical pilot study including 6 patients with advanced renal cell carcinoma will be performed. The primary objective is to evaluate the tolerability and safety of the treatment. The secondary objective is to characterize antitumor immune responses (immune monitoring) as well as to assess the clinical effect of the treatment by use of the objective response rate (using RECIST 1.1). In addition, overall survival (OS) and progression-free survival (PFS) will be described, but not included as endpoints. The pilot study will be followed by a phase II trial, if the treatment proves to be feasible and tolerable.
The treatment involves infusion of tumor-infiltrating lymphocytes (TILs) isolated from the patient's own tumor tissue as well as administration of lymphodepleting chemotherapy and subsequent high-dose bolus administration of the immune-stimulating cytokine, interleukin-2 (IL-2).
(Clinicaltrials.gov ID NCT02926053)