A phase I/IIa safety, dose finding and feasibility trial of CD30/CEA CART in patients with liver metastases from CEA positive colorectal adenocarcinoma
This clinical trial is testing a new experimental treatment for people with bowel cancer (colorectal cancer) that has spread to the liver. The treatment is a type of immunotherapy known as CAR-T cell therapy. It uses modified immune cells designed to hunt down and attack specific cancer proteins called CEA and CD30. Because this is the first time this specific therapy is being tested in humans, the main goal is safety. Doctors want to find out what dose is safe, learn what side effects occur, and see how well the body handles the treatment. They will also look for early signs that the therapy is helping to shrink or control the cancer. The trial is open to adults aged 18 and older whose cancer produces the CEA protein.
At a glance
What is this study about?
Bowel cancer is one of the most common cancers, and it sometimes spreads to other organs, most often the liver. When cancer spreads like this, it can be much harder to treat with standard options such as chemotherapy or surgery alone. Researchers are working on new, targeted ways to fight advanced cancer by helping the body's own immune system recognise and destroy cancer cells.
In this trial, scientists are studying a new form of CAR-T cell therapy. CAR-T is a treatment where doctors take some of your own immune cells (T-cells) and reprogram them in a laboratory. These reprogrammed cells are given special sensors to track down specific markers found on cancer cells, named CEA and CD30. Once returned to the body, these cells act like trained search dogs to find and attack the tumour.
This trial is an early-stage study, meaning it is the very first time this particular treatment is being tested in people. The main purpose is not yet to prove whether it works better than other therapies, but to make sure it is safe to use and to discover the right dose. By joining, participants help researchers take a crucial step toward developing newer, more effective treatments for advanced bowel cancer.
Key takeaways
- Tests a new CAR-T immune therapy for bowel cancer that has spread to the liver.
- First-in-human trial designed primarily to find a safe dose and identify side effects.
- Requires your tumour to test positive for a specific marker called CEA.
- Uses your own reprogrammed immune cells to target cancer cells.
- Participation includes hospital monitoring, regular clinic visits, and scans.
Who may be eligible?
This study is open to adults aged 18 and older of any gender who have colorectal adenocarcinoma (a common type of bowel cancer) that has spread to the liver. To take part, your cancer cells must test positive for a protein called CEA, which the new treatment is designed to target.
Because this is an early-stage study testing safety, participants will need to have a general health check to ensure their vital organs, like the heart and kidneys, are working well enough to safely cope with the treatment. The trial doctors will also review your past cancer treatments.
People who do not have the CEA protein on their tumours, or those who have severe ongoing medical issues or active infections, may not be able to join. Your hospital doctor or the study team can look at your medical records and perform simple tests to see if you meet all the 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.
- I am aged 18 or older.
- I have been diagnosed with bowel cancer (colorectal adenocarcinoma).
- My cancer has spread to my liver.
- My cancer has tested positive (or can be tested) for the CEA protein.
- I feel well enough to attend regular hospital visits and scans.
What does participation involve?
Taking part in this study begins with screening tests, such as blood samples, scans, and physical exams, to check if the trial is safe for you. If you join, doctors will collect some of your immune cells through a standard blood-filtering process. These cells are sent to a specialist laboratory to be prepared, which can take a few weeks.
Before receiving the new cells back, you may have short courses of medication to prepare your body. You will then receive the CAR-T cells through a drip into a vein. Because this is a new treatment, you will likely stay in hospital for a short period so the medical team can watch closely for any side effects.
Afterwards, you will need to attend regular clinic visits for blood tests and imaging scans (like CT or MRI) to see how the cells are working and check for changes in your tumours. Follow-up visits continue for several months or longer to monitor your long-term health.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is CAR-T cell therapy?
It is a treatment that takes your own immune cells, modifies them in a lab to better recognise cancer cells, and puts them back into your bloodstream.
Why is this called a Phase 1/2 trial?
Phase 1 focuses on finding the safest dose and checking side effects in humans. Phase 2 begins to look more closely at how well the treatment shrinks the cancer.
Will taking part cure my cancer?
This trial is in its earliest stages, so doctors cannot promise it will cure your cancer. The primary aim is to test safety and see if the treatment can slow tumour growth.
Do I have to stay in hospital?
Yes, you will likely need to stay in the hospital for observation when you receive the cells so doctors can quickly treat any immediate side effects.
Can I leave the study if I change my mind?
Yes. You can leave the trial at any point for any reason, and your medical team will continue to offer you the best standard care available.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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