Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies
Who is this study for? Adult patients with Locally Advanced or Metastatic Bladder Cancer
What treatments are being studied? 4SCAR-T Cell Therapy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Shenzhen Geno-immune Medical Institute
RECRUITING
Shenzhen
Shenzhen Second People Hospital
RECRUITING
Shenzhen
Contact Information
Primary
Lung-Ji Chang, PhD
c@szgimi.org
86-13671121909
Backup
Aifa Tang, PhD
tangaifa2004@163.com
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 20
Treatments
Experimental: 4SCAR-PSMA
4SCAR PSMA-modified T cells can recognize and kill tumor cells through the recognize of PSMA .This study will evaluate the side effects and effective doses of 4SCAR-PSMA T cells in treating refractory and recurrent solid tumors.
Experimental: 4SCAR-FRa
4SCAR FRa-modified T cells can recognize and kill tumor cells through the recognize of FRa .This study will evaluate the side effects and effective doses of 4SCAR-FRa T cells in treating refractory and recurrent solid tumors.
Related Therapeutic Areas
Sponsors
Leads: Shenzhen Geno-Immune Medical Institute