AuthorisedTherapeutic exploratory (Phase II)Interventional

Multi-center, single-arm, phase II clinical trial evaluating efficacy and in-vivo homing of adoptively transferred autologous ex-vivo expanded regulatory T cells in adults with ulcerative colitis

This research study is looking at a new way to treat ulcerative colitis, a condition that causes inflammation in the large bowel. It’s for adult patients aged 18 and over. The treatment involves a type of cell therapy where your own special immune cells, called regulatory T cells, are taken from your blood. These cells are then grown in a lab to make more of them, and later given back to you. The main goal is to see if this treatment can help people go into 'remission' – meaning their symptoms like bleeding and frequent stools improve – within 12 weeks of starting the treatment. This is a Phase II trial, meaning researchers are further checking if the treatment is effective and safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaetsklinikum Erlangen AöR

Enrolment target

Start

21 Aug 2025

Ulcerative colitis

What is this study about?

This study is a clinical trial exploring a new potential treatment for ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops tiny ulcers. This can cause tummy pain, diarrhoea, and bleeding.

The new treatment being tested involves using your body's own immune cells. Specifically, researchers are focusing on 'regulatory T cells,' which are like the peacekeepers of your immune system – they help calm down inflammation. In this study, these cells would be taken from your blood, grown in a special lab to increase their numbers, and then given back to you. The idea is that these boosted regulatory T cells could help reduce the inflammation in your bowel.

This is a Phase II study, which means it’s an important step in testing new treatments. The main aim is to see if this cell therapy can help people achieve 'clinical remission,' which means a significant reduction or disappearance of their ulcerative colitis symptoms, within 12 weeks of receiving the treatment. It's a key stage to understand how well the treatment works and if it's safe for patients.

Key takeaways

This study is testing a cell therapy for adults with ulcerative colitis.
It uses your own immune cells to try and reduce inflammation.
The main goal is to see if it helps achieve symptom remission within 12 weeks.
Participation involves clinic visits, blood tests, and receiving an infusion.
It's a Phase II trial, meaning it's assessing effectiveness and safety.
You can stop participating at any time.

Who may be eligible?

This study is open to adults aged 18 years and older who have been diagnosed with ulcerative colitis. Both men and women can take part.

To be eligible, you would generally need to have active ulcerative colitis that hasn't responded well to standard treatments, or if other treatments aren't suitable for you. You would also need to be well enough to safely participate in the study.

The research team will carry out several tests and checks to make sure this study is the right fit for you. They will look at your medical history and current health to confirm if you meet all the specific requirements.

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 a diagnosis of ulcerative colitis?
Are you able to visit the study clinic regularly?
Are you willing for your blood to be taken for cell collection and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several visits to the clinic over a period of time. Initially, you would have tests to check if you are suitable. If you are, some blood would be taken to collect your special immune cells. These cells would then be sent to a lab to be grown.

Once enough cells are ready, you would come back to receive your treatment, which is given by an infusion (like a drip into your arm). After getting the treatment, you would have follow-up appointments over 12 weeks. These visits will involve physical examinations, blood tests, and possibly some bowel checks (like endoscopy) to see how your condition is responding and if the treatment is safe. The total length of your participation, from your first visit to your final follow-up, would be confirmed by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the new cell therapy might help improve your ulcerative colitis symptoms and lead to remission, especially if other treatments haven't worked for you. However, there's no guarantee it will help everyone. Potential risks could include side effects from the cell collection, the cell infusion itself, or possible reactions to the cells once they are in your body. The research team will carefully monitor you for any side effects. You are always free to 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.

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Unverified
Germany

Common questions

What are 'regulatory T cells'?

They are a type of immune cell that helps control and calm down inflammation in your body. In this study, we're testing if boosting their numbers can help with ulcerative colitis.

Is this a new type of treatment?

Yes, this cell therapy is still being researched. It's considered an investigational treatment, meaning it's not yet available as a standard treatment.

How will I receive the treatment?

The treatment will be given to you as an infusion, sometimes called a 'drip,' usually into a vein in your arm, similar to how you might receive other medications.

How long will I need to be in the study?

The main part of the study involves follow-up for 12 weeks after you receive the treatment. The total time from checking if you're suitable to your last visit will involve more time, which the study team will explain.

What does 'clinical remission' mean?

It means that your ulcerative colitis symptoms, like rectal bleeding and frequent stools, have significantly improved or gone away, based on specific medical assessments.