About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
1. Individuals who are allergic to any component of the investigational product.
Trial design
Treatments tested in this trial
- JL19001 Injection