Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer

This study is investigating a new way to treat non-muscle invasive bladder cancer, which is a type of bladder cancer that has not grown into the deeper muscle layers of the bladder wall. Researchers are combining an established treatment called BCG (Bacillus Calmette-Guerin) with an experimental drug known as N-803. The main goal is to find out if using N-803 alongside BCG is more effective at clearing the cancer from the bladder compared to BCG alone. They will be checking how many people become free of cancer after treatment and for how long. The study is particularly interested in seeing if this new combination can offer a better outcome for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Immunitybio Inc.

Enrolment target

Start

26 Aug 2025

Non-Muscle Invasive Bladder Cancer

What is this study about?

This study is looking into a new treatment approach for a type of bladder cancer called non-muscle invasive bladder cancer. This means the cancer is only on the surface lining of the bladder and hasn't spread into the deeper muscle layer. Existing treatments work well for many people, but researchers are always trying to find even better options.

The study involves two existing treatments. One is called BCG (Bacillus Calmette-Guerin), which is a common and effective treatment for this type of bladder cancer. It's given directly into the bladder using a small tube. The other treatment is an experimental drug known as N-803. Researchers want to see if combining N-803 with BCG can improve how well the treatment works.

There are two main groups of people in this study. For some, the study will compare people who receive the new combination of N-803 plus BCG with those who only receive BCG. For others, both groups will receive a combination treatment and the study will track how long participants remain cancer-free over time. The overall aim is to identify if this new combination can lead to a higher number of people becoming cancer-free and staying that way for longer.

Key takeaways

This study is testing a new combined treatment for bladder cancer.
It's for bladder cancer that hasn't spread into the muscle.
The new treatment combines standard BCG with an experimental drug called N-803.
The main goal is to see if this combination works better at getting rid of the cancer.
You would receive treatment directly into your bladder.

Who may be eligible?

To be able to join this study, you would generally need to be an adult, aged 18 or over. This study is open to both men and women.

The specific details about your bladder cancer, such as how it was diagnosed and previous treatments you've had, will be important for deciding if you can take part. There might be some other medical conditions or medications you are taking that would mean you can't join for your safety or to make sure the study results are clear.

A doctor or nurse involved in the study would carefully review your medical history and current health to confirm if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have non-muscle invasive bladder cancer?
Have you discussed this study with your doctor?
Are you able to attend regular hospital or clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive treatments that are given directly into your bladder using a thin tube (this is called 'intravesical instillation' or 'bladder instillation'). You would have regular appointments at the hospital or clinic for these treatments and to have check-ups. These check-ups will involve doctors examining you and possibly having scans or procedures to see how your bladder cancer is responding to the treatment. The research team would explain the exact schedule of visits and what each visit would involve, including how often you would receive the medication and for how long. The whole study might involve follow-up for several months or even a few years.

Potential risks and benefits

Participating in a study like this could potentially offer benefits, such as receiving a new combination treatment that might be more effective than standard care, or receiving closer monitoring of your condition. However, there are also potential risks involved, as with any medical treatment. The new drug N-803 might have side effects that are not yet fully known, or it could interact with the BCG in ways we don't fully understand. The research team would explain all known side effects of both treatments. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany

Common questions

What is 'non-muscle invasive bladder cancer'?

It's a type of bladder cancer that is only in the lining of the bladder and hasn't spread into the deeper muscle layers.

What is BCG?

BCG is a common type of immunotherapy treatment for bladder cancer, given directly into the bladder.

What is N-803?

N-803 is an experimental drug being tested in combination with BCG to see if it can improve bladder cancer treatment.

Will I definitely receive the new combination treatment?

The study is comparing different approaches, so you might receive the new combination, or you might receive BCG alone, depending on which group you are in.

How long will the study last if I join?

The study involves treatment and follow-up over several months, possibly up to a few years, to track your progress over time.