This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.
Voluntarily agrees to participate in this study and provides written informed consent prior to the initiation of any study-specific procedures.
Is aged ≥18 years at the time of signing the informed consent form (ICF).
Cohort A: high-risk non-muscle-invasive bladder cancer (NMIBC).
Cohort B: intermediate-risk NMIBC.
Low-risk NMIBC.
Very high-risk NMIBC.
Tumors staged as T2 or higher, or urothelial carcinoma of the upper urinary tract or urethra (renal pelvis, ureter, or urethra).
Predominantly non-urothelial histology, including squamous cell carcinoma, adenocarcinoma, or other non-urothelial carcinomas.