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

Metastatic Urothelial Carcinoma Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Metastatic Urothelial Carcinoma

• NCT number: NCT04383067
• Study type: Interventional
• Source: Sheba Medical Center
• Contact: Ronnie Shapira, MD.
• Phone: +972-3-5308414
• Email: Ronnie.Shapira@sheba.health.gov.il
• Status: Recruiting
• Phase: Phase 2
• Start date: May 12, 2020
• Completion date: June 1, 2023