Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT07297667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours
Sponsor:
Canadian Cancer Trials Group
Organization:
Study Overview
Official Title:
A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed/Refractory GPNMB-Expressing Solid Tumours
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
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:
This study is being done to answer the following questions:
* Is the new cell therapy, GCAR1, safe to use, and what effects does it have on cancer?
* What is the right dose of the treatment which could be used in future studies?
* Is the new cell therapy, GCAR1, safe to use, and what effects does it have on cancer?
* What is the right dose of the treatment which could be used in future studies?
Detailed Description:
GCAR1 is an autologous chimeric antigen receptor (CAR-T) cell therapy. Autologous means that it is made from a specific person's own white blood cells. These white blood cells are collected from the person and are modified in a laboratory to be able to better find and destroy cancer cells.
We are doing this study because to find out if this approach is better or worse than the usual approach for cancer. The usual approach is defined as care most people get for this type of cancer.
The usual approach for patients who are not in a study is treatment with chemotherapy or other anti-cancer drugs. The drugs chosen will depend on the type of cancer. If there is kidney or breast cancer, radiation therapy may also be used. The study doctor can explain which treatment may be best. These treatments can reduce symptoms and may stop the tumour from growing for a few months or longer.
We are doing this study because to find out if this approach is better or worse than the usual approach for cancer. The usual approach is defined as care most people get for this type of cancer.
The usual approach for patients who are not in a study is treatment with chemotherapy or other anti-cancer drugs. The drugs chosen will depend on the type of cancer. If there is kidney or breast cancer, radiation therapy may also be used. The study doctor can explain which treatment may be best. These treatments can reduce symptoms and may stop the tumour from growing for a few months or longer.
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?: