Intervention of Bladder Cancer by CAR-T
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra) 2. Representative tumor specimens as specified by the protocol 3. Adequate hematologic and end organ function 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Life expectancy greater than or equal to (\>/=) 12 weeks 6. Measurable disease, as defined by RECIST v1.1 Exclusion Criteria: 1. Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment 2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment 3. 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 4. Leptomeningeal disease 5. Malignancies other than UBC within 5 years prio