A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.
Phase Ia, an open-label, sequential, dose escalation study to evaluate the tolerability and safety of JL19001 Injection alone in subjects with high risk NMIBC. The investigators plan to test 3 dose levels, 100, 200, and 400 μg in the Phase Ia study. A traditional 3 + 3 dose escalation design will be used. Eligible subjects will be sequentially enrolled and will be observed for DLT(s) during the DLT monitoring period (Day 1 \ 21).
• 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.