Spots Global Cancer Trial Database for A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients

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Trial Identification

Brief Title: A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients

Official Title: A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients

Study ID: NCT04383067

Conditions

Metastatic Urothelial Carcinoma

Interventions

Tumor Infiltrating Lymphocytes (TIL)

Proleukin

Study Description

Brief Summary: An autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients.

Detailed Description: This is a phase II single-center study of Tumor Infiltrating Lymphocytes (TIL) in urothelial carcinoma patients who failed at least one line of platinum based chemotherapy and one line of immunotherapy of targeted therapy. Patients will undergo a baseline evaluation including imaging, blood and urine samples, EVG and physical examination to confirm suitability for the study. Eligible patients will undergo surgery to collect a tumor sample for TIL culturing. Patients will receive an autologus TIL infusion once the cells have been properly cultured. Following the infusion, patients will receive a high dose of IL-2. Following the intervention, patients will be monitored to evaluate study endpoints.