Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies
This is a new study looking at an advanced cell therapy called KCAT19. It's for adults between 16 and 65 years old who have certain blood cancers (like some types of lymphoma or leukaemia) that have come back or haven't gotten better with standard treatments. This first-stage study (Phase 1) aims to see if these KCAT19 cells can be made successfully, if they are safe for patients, and to get an early idea of whether they might help fight the cancer. The KCAT19 cells are specially designed in a lab to find and attack cancer cells in the body.
At a glance
What is this study about?
You've been given information about a new research study looking into a special type of cell therapy called KCAT19. This therapy is designed to treat certain advanced blood cancers that haven't responded well to standard treatments or have come back. This is a 'Phase 1' study, which means it's one of the first times this treatment is being tested in people. The main goals are to make sure the therapy is safe and to see if there are early signs that it could be effective against the cancer.
The KCAT19 therapy involves taking T cells, which are a type of immune cell, from a healthy donor (specifically from cord blood). These donor cells are then carefully changed in a lab to help them recognise and attack cancer cells that have a specific marker called CD19. Think of it like giving your body's defence system a new set of 'eyes' to spot and destroy cancer cells more effectively. Once these special KCAT19 cells are ready, they are given back to the patient through a drip.
Before you receive the KCAT19 cells, you will have some preparation treatments, including chemotherapy, to get your body ready. After receiving the KCAT19 cells, you will be closely monitored by the study team. This whole process is done under very careful medical supervision to ensure your safety and to learn as much as possible about how the new treatment works.
Key takeaways
- This is a new cell therapy (KCAT19) for advanced blood cancers.
- It's an early-stage study (Phase 1) focused on safety and early effectiveness.
- The therapy uses specially modified immune cells from a healthy donor.
- You will receive chemotherapy before getting the KCAT19 cells.
- Close hospital monitoring is needed after the treatment.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for adults aged 16 to 65 years old. You might be suitable if you have a specific type of blood cancer (like certain kinds of lymphoma or leukaemia) that has either come back after treatment or hasn't responded to at least two different treatments.
Your cancer cells must also have a specific marker on their surface called CD19. The study needs to confirm this. You would need to be well enough to take part, meaning you don't have certain other serious health conditions like uncontrolled infections, very poor organ function, or an active cancer in your brain or spinal cord.
Important points that might mean you can't join include being pregnant or breastfeeding, having certain serious infections like active Hepatitis B, C, or HIV, or needing high doses of certain steroid medications. Your doctor will carefully review all your medical information to see if this study is right 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 between 16 and 65 years old?
- Do you have a type of blood cancer that has come back or not responded to previous treatments?
- Has your doctor confirmed your cancer cells have the CD19 marker?
- Are you generally well enough to undergo intensive treatment?
- Are you not pregnant or breastfeeding?
- Do you not have certain other serious health issues like active infections or very poor organ function?
What does participation involve?
If you decide to take part, you'll first sign a consent form to show you understand and agree. Then, the special KCAT19 cells will be made in a lab using donor cells. This process takes about 15 days. During this time, you might receive some standard chemotherapy to keep your cancer under control.
Before you receive the KCAT19 cells, you will be admitted to hospital for a few days to have more chemotherapy, which helps prepare your body for the new cells. On 'day 0', you will receive the KCAT19 cells through a drip, just like a normal IV infusion. After this, you will stay in the hospital for at least 14 days so the medical team can closely watch how you are doing and manage any side effects. The study team will explain all the hospital visits, follow-up appointments, and tests you'll need after you leave the hospital, including how long the study will monitor your health.
Potential risks and benefits
Locations (1)
- University College London HospitalVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What are KCAT19 T cells?
They are special immune cells, taken from a healthy donor, that have been changed in a lab to find and attack your cancer cells more effectively.
What is a 'Phase 1' study?
It's the first stage of testing a new treatment in people. The main goals are to check if it's safe and to see early signs if it works.
Will I get chemotherapy during the study?
Yes, you will likely have chemotherapy before receiving the KCAT19 cells to prepare your body for the new treatment.
How long will I be in the hospital?
You will be in hospital for treatment and then for at least 14 days afterwards for close monitoring.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, and it won't affect your future medical care.
How to find out more
David Gear
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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