Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT04383067
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2020-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Sheba Medical Center
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: