Intervention of Bladder Cancer by CAR-T (NCT03185468) | Clinical Trial Compass
RecruitingPhase 1/2
Intervention of Bladder Cancer by CAR-T
China20 participantsStarted 2025-08-01
Plain-language summary
This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of 4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have no further treatment available.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)
. Representative tumor specimens as specified by the protocol
. Adequate hematologic and end organ function
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
. Life expectancy greater than or equal to (\>/=) 12 weeks
. Measurable disease, as defined by RECIST v1.1
Exclusion criteria
. Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
. Leptomeningeal disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival rate after receiving 4SCART infusion
Timeframe: 1 year
2
Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion