Testing a New Bladder Cancer Treatment for Patients Who Didn't Respond to Standard Therapy

Plain-English translation of NCT05126472 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new medication called 2141-V11, which is injected directly into the bladder to help your immune system fight bladder cancer. The study focuses on people whose cancer did not respond to standard BCG treatment (a common first-line therapy for bladder cancer). Researchers want to see if this new approach is safe and whether it helps prevent the cancer from coming back.

Many patients with bladder cancer don't respond well to the standard BCG treatment, and the traditional next step—removing the entire bladder—is a major surgery that some patients cannot have or choose not to have. This trial exists to find a less invasive option that might work for these patients.

Do you qualify?

You likely qualify if…

you have been diagnosed with high-grade bladder cancer that did not respond to adequate BCG therapy
your cancer is either confined to the inner lining of the bladder (Ta or CIS) or has invaded slightly deeper (T1), with urothelial cell type as the main component
you have either chosen not to undergo bladder removal surgery or your doctors have determined you are not a good candidate for it
your most recent bladder procedure (cystoscopy or TURBT) was performed within the last 6 months
you do not have cancer in your upper urinary tract (ureters or kidneys)

You likely don't qualify if…

you have cancer that has invaded deep into the muscle layer of the bladder (except for Cohort C, which specifically includes muscle-invasive disease)
you have non-urothelial types of bladder cancer as your main cancer type
you have active cancer in your upper urinary tract
you have serious cardiovascular disease or other major medical conditions that make surgery too risky
you have not completed adequate BCG therapy before enrolling

What participation looks like

If you enroll in this study, you will receive injections of the medication directly into your bladder during a standard cystoscopy procedure (a camera exam of the bladder). Depending on which group you join, you may receive multiple treatment cycles over several weeks or months. You will have regular follow-up visits with cystoscopy exams to monitor how your bladder is responding, and your doctors will watch closely for any side effects or signs of cancer recurrence.

AI-generated summary from trial data · Jun 13, 2026 · Not medical advice

Trial locations(7 sites)

United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York