Intervention of Bladder Cancer by CAR-T
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShenzhen Geno-Immune Medical Institute
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 4SCAR-PSMA
- 4SCAR-FRa
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov