Testing a new gene therapy for bladder cancer resistant to standard treatment

Plain-English translation of NCT06545955 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing a new treatment called , which is a type of gene therapy delivered directly into the bladder. The medication is being studied on its own or combined with chemotherapy drugs to help people whose bladder cancer has stopped responding to the standard BCG treatment. The goal is to see if this new approach can help more patients avoid bladder removal surgery.

Many people with high-grade bladder cancer stop responding to BCG treatment, which is currently the best option available. This medication represents a new way to fight the cancer that may work better for patients when standard treatments no longer help.

Do you qualify?

You likely qualify if…

you have been diagnosed with carcinoma in situ (CIS) or high-grade bladder cancer (Ta or T1 stage)
your bladder cancer has not responded to at least 2 courses of BCG treatment within the last 12 months
you have had all visible tumors surgically removed from your bladder before entering the trial
you are 18 years or older and in reasonably good overall health
you are able to attend all trial visits and willing to try this new treatment instead of bladder removal surgery
you have a life expectancy of more than 2 years

You likely don't qualify if…

you have cancer in your upper urinary tract or in the prostatic urethra
you have advanced or locally spread bladder cancer
you are pregnant or unwilling to use effective birth control
you have had fewer than 2 full courses of BCG treatment
you have muscle-invasive bladder cancer (cancer that has grown into the muscle layer)

What participation looks like

If you join, you will receive the new gene therapy instilled directly into your bladder, either alone or combined with chemotherapy drugs given either into the bladder or through an IV infusion. You will need to attend regular visits for monitoring, bladder exams, and tests to see how well the treatment is working. The trial will track your progress over time to measure whether this new approach helps prevent cancer recurrence and keeps your bladder intact.

AI-generated summary from trial data · Jul 16, 2026 · Not medical advice

Testing a new gene therapy for bladder cancer resistant to standard treatment

What is this trial?

Do you qualify?

What participation looks like

Trial locations