NCT04383067

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Urothelial Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Tumor Infiltrating Lymphocytes (TIL)	Patient with metastatic urothelial carcinoma will undergo a autologous lymphocyte transplantation. Patient will undergo surgery to remove either the primary tumor or a tumor metastasis. The cells collected in this surgey will be cultured and reintroduced to the patient. Following the cell infusion, patient will receive a high-dose bolus of IL-2.
DRUG	Proleukin	high-dose (720,000 IU/kg) IL-2 will be administered every 8 hours, to tolerance. A maximum of 10 doses will be administered

Timeline

• Start date: 2020-05-12
• Primary completion: 2022-06-01
• Completion: 2023-06-01
• First posted: 2020-05-11
• Last updated: 2021-02-11

Locations

1 site across 1 country: Israel