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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJecho Biopharmaceuticals Co., Ltd.

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

Treatment groups

18 Participants
are divided into 3 treatment groups

Locations

This trial has no locations