A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.

Inclusion criteria

• ✓. Subjects should voluntarily sign the informed consent, and agree to comply with all protocol-specified procedures .
• ✓. Male or female patients ≥18 years of age at the time of signing the ICF.
• ✓. Life expectancy ≥ 2 years.
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• ✓. Previous pathological biopsy was diagnosed as high-risk NMIBC.
• ✓. Cystoscopy showed complete resection of the lesion or the residual lesion is only CIS within 6 weeks prior to initial administration; For T1 lesions, postoperative pathological results must show the presence of bladder muscle layer.
• ✓. After fully understanding the benefits, risks, and alternatives of radical cystectomy, the subject voluntarily chooses not to undergo the surgery; or the subject is deemed unsuitable for radical cystectomy by the researcher
• ✓. Subjects with fertility and their partner should use contraception during the study treatment period and within 12 weeks after the end of the study treatment period. Non-surgical sterilized female subjects of reproductive age must be negative for serum HCG within 7 days prior to initial administration and must be non-lactating.