Actively Recruiting
Intervention of Bladder Cancer by CAR-T
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2025-09-08
20
Participants Needed
2
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intervention of Bladder Cancer by CAR-T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic urothelial bladder cancer (including renal pelvis, ureters, urinary bladder, and urethra)
- Availability of representative tumor specimens as required by the protocol
- Adequate blood counts and organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Measurable disease according to RECIST v1.1 criteria
You will not qualify if you...
- Received any approved anti-cancer therapy within 3 weeks before study treatment
- Participated in another clinical trial with therapeutic intent or received investigational agents within 28 days prior to enrollment
- Active or untreated central nervous system metastases
- Presence of leptomeningeal disease
- Other cancers within 5 years prior to the study start
- Pregnant or breastfeeding women
- Significant heart disease
- Severe infections within 4 weeks before infusion
- Major surgery (other than biopsy) within 4 weeks before infusion
- History of severe allergic reactions to antibodies or related therapies
- History of autoimmune diseases
- Prior allogeneic stem cell or organ transplants
- History or evidence of certain lung diseases or active pneumonitis
- Positive for HIV, active hepatitis B or C, or tuberculosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Shenzhen Second People Hospital
Shenzhen, Gongdong, China
Actively Recruiting
2
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
Lung-Ji Chang, PhD
CONTACT
A
Aifa Tang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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