A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Ri… (NCT07483970) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.
18 participantsStarted 2026-03-30
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with reported Dose-limiting toxicity (DLT)
Timeframe: Within 21 days after the first administration
2
Rate of adverse events
Timeframe: Up to 3 years
3
Determine the recommend dose for combination for JL19001 injection
. 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.