Clinical Trial

Disease: Muscle-Invasive Bladder Cancer, MIBC, (NCT02863913)

Disease info:

The bladder is a muscular organ in the lower abdomen that stores urine until it can be removed (excreted) from the body.

Bladder cancer is a disease in which certain cells in the bladder become abnormal and multiply uncontrollably to form a tumor.

The most common type of bladder cancer, called non-muscle invasive bladder cancer (NMIBC), involves cells lining the inside of the bladder. NMIBC generally does not spread to other tissues (metastasize), but it often does recur after it has been treated.

The other type, called muscle-invasive bladder cancer (MIBC), involves cells of the muscle wall of the bladder. MIBC generally does metastasize and is often life-threatening.

Bladder cancer occurs four times more often in men than in women. In the United States about 60,000 men and 18,000 women are diagnosed with the condition each year.
Official title:
A Dose-escalation Phase I Trial of PD-1 Knockout Engineered T Cells for the Treatment of Muscle-invasive Bladder Cancer

China, Beijing

Department of Urology Peking University First Hospital, Beijing, Beijing, China, 100034

Study start:
Sep. 1, 2016
0 participants
Gene editing method:
Type of edit:
Gene knock-out
Programmed cell death protein 1 (PDCD1)
Delivery method:
- Ex-vivo
Withdrawn due to lack of funding.
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Suspended


This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.

Last updated: Dec. 28, 2023
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