RecruitingPHASE1, PHASE2INTERVENTIONAL

A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC

This research study is an early-stage trial (Phase 1/2a) looking into a new treatment called CC-38. This treatment uses a special type of immunotherapy, which involves taking some of your own immune cells, called T-cells, and growing them in the lab to make them stronger at fighting cancer. These specially prepared cells are then given back to you. The study includes people with bowel cancer that has spread (metastatic colorectal cancer) or prostate cancer that has spread or is locally advanced. The main goal is to check how safe this new treatment is and if it can help fight these types of cancer, which haven't been widely studied with this kind of T-cell therapy before. We also want to see if giving these cells more than once helps them stay in your body longer and attack the cancer more effectively.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Curacell Holding AB

Enrolment target

Start

13 Nov 2025

Estimated completion

01 Apr 2029

Metastatic Colorectal Cancer Prostate Cancer Metastatic Prostate Cancer Locally Advanced

What is this study about?

This study is an early investigation into a new cancer treatment. It's called a 'First-In-Human' trial, meaning it's one of the first times this specific treatment method is being used in people. The treatment is a type of immunotherapy, which essentially uses your body's own immune system to find and destroy cancer cells. In this case, it involves taking a small piece of your tumour. From this piece, special immune cells called T-cells are extracted. These T-cells are then grown and made stronger in a lab (this specially prepared treatment is called CC-38).

Once they are ready, these powerful T-cells are given back to you as a treatment. The study is specifically looking at people who have advanced bowel cancer (colorectal cancer that has spread) or prostate cancer (that has spread or is locally advanced). While similar T-cell treatments have shown promise in other cancers like melanoma, they haven't been widely tested for bowel or prostate cancer yet. That's why this study is so important.

The main idea behind this study is to see if giving these specially prepared T-cells, potentially more than once, can help them stay in your body for a longer time. The hope is that if these T-cells stay active for longer, they will be more likely to find and attack the cancer cells, leading to a better outcome for patients. The researchers will be closely watching for any side effects and how well the treatment works.

Key takeaways

Tests a new immune cell therapy (CC-38) for advanced bowel or prostate cancer.
Uses your own T-cells, grown stronger in a lab, to fight cancer.
Aims to see if the treatment is safe and helps fight cancer.
Includes people whose standard treatments haven't worked well.
You will need a tumour sample, likely through surgery, to participate.
This is an early-stage trial, so not all effects are known.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have signed a consent form. You also need to live within about 30 miles of a hospital that can provide the necessary care during the study.

The study is for people with certain types of advanced cancer: either bowel cancer that has spread (stage IV) and cannot be removed by surgery, or prostate cancer that is advanced locally (stage III) or has spread (stage IV) and cannot be removed by surgery. You must have already tried all standard treatments for your cancer that are available through the NHS and they either didn't work well enough, or you couldn't have them, or chose not to.

Researchers will need a sample of your tumour tissue to create the special immune cells for the treatment. This might involve having some surgery, either for a tumour you were already planning to have removed, or specifically to get this tissue. You also need to be generally well enough to undergo the procedures, with a good overall health status and a life expectancy of at least six months.

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 advanced bowel cancer (that has spread) or advanced prostate cancer (that has spread or is locally advanced)?
Have you already tried standard treatments for your cancer, and they didn't work well enough?
Can you travel to a hospital within about 30 miles for your care?
Are you able to have a small surgery to remove a piece of your tumour?
Do you feel generally well enough for a study like this?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several steps. First, you'll have some tests to confirm you're eligible. Then, a small piece of your tumour will be removed, either during planned surgery or a new procedure, so your immune cells can be prepared in the lab (this can take some time). Once your personalised treatment is ready, you will receive infusions of the CC-38 immune cells. You may also receive other medications, such as Pembrolizumab, Cyclophosphamide, Interleukin-2, and Uromitexan, which are commonly used alongside this type of therapy. You will have regular check-ups, scans, and blood tests to monitor how you're responding to the treatment and to check for any side effects. The study involves different phases, and the total duration in the study will depend on how you respond and the study protocol, but it will involve ongoing assessments and follow-up to track your health and the effects of the treatment over time.

Potential risks and benefits

Participating in an early-stage clinical trial like this means you might be among the first to receive a new treatment that could potentially help fight your cancer, especially if standard treatments haven't worked. However, there are also risks. Because this is a new treatment, not all side effects are known, and some could be serious. You will be closely monitored for any reactions. There's no guarantee the treatment will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Krankenhaus Nordwest
Verified postcode
Frankfurt, Germany· Recruiting

Common questions

What is 'immunotherapy'?

Immunotherapy is a type of treatment that uses your body's own immune system to fight cancer.

What are 'T-cells'?

T-cells are special immune cells that help your body recognise and destroy harmful cells, like cancer.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started to other parts of your body.

Will I need surgery if I join this study?

Yes, you will likely need surgery to remove a piece of your tumour so that the special immune cells can be prepared for your treatment.

Is this a cure for cancer?

This is an early-stage study to see if the new treatment is safe and if it can help fight cancer. It's not yet known if it will cure cancer.

How to find out more

Dragan Kiselicki, Dr.

probetility@ikf-khnw.de 0069 7601 4420 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.