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 ovarian cancer (OC).
A clinical pilot study including 6 patients with advanced OC 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 administration of the immune-stimulating cytokine, interleukin-2 (IL-2), in accordance with the decrescendo regimen.
UPDATE NOVEMBER 2016: Patient inclusion has stopped and a phase I/II study is planned in 2017.
(Clinicaltrials.gov ID NCT02482090)