MedTrace Logo

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

NCT07483970 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-06

No results posted yet for this study

Summary

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).

Conditions

  • High Risk Non-muscle Invasive Bladder Cancer

Interventions

DRUG

JL19001 Injection

JL19001 Injection (100, 200, or 400 μg) will be administrated weekly for 6 consecutive weeks during induction treatment period, and then weekly for 3 consecutive weeks at month 3, 6, 9, 12, 18, 24, 30 and 36 during extension treatment period until disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent, lost to follow-up, death, other reasons for withdrawal from treatment, or the end of treatment, whichever occurs earlier.

Sponsors & Collaborators

  • Jecho Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qiang Wei · West China Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2027-03-30
Completion
2028-03-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07483970 on ClinicalTrials.gov