BCG Vaccine (Chengdu Institute of Biological Products)

Primary objective: Dose escalation: Evaluate the safety and tolerability of SIM0237 alone or in combination with BCG, and determine the recommended dose (RD) for monotherapy or combination therapy. Dose expansion: Evaluate the preliminary efficacy of SIM0237 alone or in combination with BCG. Secondary objectives: Dose escalation: Evaluate the preliminary efficacy of SIM0237 alone or in combination with BCG; further evaluate the safety of SIM0237 alone or in combination with BCG; Dose expansion: Evaluate the safety and tolerability of SIM0237 alone or in combination with BCG; further evaluate the efficacy of SIM0237 alone or in combination with BCG; Dose escalation and expansion: Evaluate the pharmacokinetics (PK) and immunogenicity of SIM0237 intravesical instillation; evaluate the correlation between programmed death ligand 1 (PD-L1) expression level and the anti-tumor activity of SIM0237.