AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Rituximab for Treatment of Checkpoint Inhibitor Induced Immune Related Adverse Events

This study is testing a drug called rituximab in people who have developed side effects from a type of cancer treatment known as "checkpoint inhibitors" (or immunotherapy). Sometimes, these powerful cancer treatments can cause the body's immune system to overreact and attack healthy parts of the body, leading to unwanted side effects. Researchers are using rituximab, a drug that works on the immune system, to see if it can help calm down these reactions and reduce the side effects. This is a very early-stage study, meaning it's one of the first times rituximab is being looked at specifically for these side effects in humans. The goal is to find out if it's safe and if it shows any promise in helping patients feel better.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Region Hovedstaden

Enrolment target

Start

30 Mar 2026

All CTCAE (v. 6.0) grade 2-4 immune-related adverse events

What is this study about?

This study is about a medicine called rituximab, and how it might help people who have developed side effects from a specific type of cancer treatment. These cancer treatments, often called 'immunotherapy' or 'checkpoint inhibitors,' work by boosting your body's own immune system to fight cancer. While very effective against cancer, sometimes this boosted immune system can become overactive and start to attack healthy parts of your body. When this happens, it's called an 'immune-related adverse event,' and it can cause a range of symptoms, from mild to quite serious.

The researchers want to see if rituximab can help manage these unwanted side effects. Rituximab is a medicine that targets certain immune cells, which could potentially help to calm down an overactive immune system. This study is an early-stage trial, which means it's one of the first times this approach is being tested in humans specifically for these side effects.

The main aim is to understand if rituximab is safe to use for these side effects and to see if it shows any signs of working to improve patients' symptoms. Findings from this study will help doctors learn more about how to best care for people experiencing these types of treatment side effects.

Key takeaways

This study is exploring a new way to treat side effects from cancer immunotherapy.
It uses a medicine called rituximab, which affects the immune system.
It's an early-stage study, meaning researchers are checking safety and early signs of effectiveness.
Participants must be adults experiencing certain levels of side effects from immunotherapy.
The goal is to find better ways to help patients manage these challenging side effects.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.

Critically, you must be experiencing side effects from your cancer immunotherapy treatment. These side effects should be of a certain level of severity, meaning they are noticeable and potentially causing discomfort or problems in your daily life. They are called 'grade 2-4' side effects, which your doctor will be able to explain more about.

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?
Are you currently having side effects from cancer immunotherapy?
Has your doctor told you these side effects are of a specific grade (2, 3, or 4)?
Are you able to attend study appointments as needed?

Answer every question to see your result.

What does participation involve?

The detailed plan for taking part in this study is not provided, but typically in early-stage studies like this, you would have several visits to the clinic. These visits usually involve check-ups with the doctors and nurses, blood tests, and other assessments to monitor your health and how you are responding to the rituximab. You would receive the rituximab medicine as part of the study.

There would also be regular follow-up appointments to track any changes in your side effects and overall health. The total time you would be involved in the study would depend on how long you receive the medication and how long the researchers need to follow your progress, but it generally involves regular monitoring over a period of time.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that rituximab might help to reduce or manage the difficult side effects you are experiencing from your cancer immunotherapy. However, there's no guarantee it will work for everyone, as this is an early-stage study. Potential risks could include side effects from rituximab itself, such as allergic reactions or infections, which the study team will monitor closely. You are always free to leave the study at any time, for any reason, without it affecting your usual care.

Locations (1)

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

—
Unverified
Denmark

Common questions

What kind of side effects is this study looking at?

This study is for side effects caused by cancer immunotherapy treatments. These can be various things, but they are important enough to need medical attention.

What is rituximab?

Rituximab is a medicine that works on your immune system. Researchers want to see if it can help calm down an overactive immune response happening as a side effect of cancer treatment.

Is this a new medicine?

Rituximab has been used for other conditions, but this study is looking at it for the first time specifically for these types of immunotherapy side effects in humans.

Who is running this study?

This is a clinical trial, meaning it's organised by medical researchers and doctors to find new ways to help patients.

Will I still get my cancer treatment?

The information provided doesn't specify, but usually, studies like this are designed to work alongside your existing cancer care. Your doctor can give you more details.