A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
This research study is investigating a new treatment called BCN-CP01 for adults who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has either returned after treatment or hasn't responded to previous therapies. This type of treatment, called CAR T-cell therapy, uses a patient’s own immune cells to fight cancer. This is an early-stage study (Phase I/II), meaning it's one of the first times this treatment is being tested in humans. The main goals are to check if the treatment is safe, what side effects it might cause, and if it can help improve the condition of people with these cancers. It's an important step in finding new ways to treat these difficult-to-treat cancers.
At a glance
What is this study about?
This study is looking into a new way to treat two types of blood cancer: chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These cancers affect a type of white blood cell called lymphocytes. The study is for people whose cancer has either come back after treatment or hasn't responded to other medicines. This new treatment is called BCN-CP01, which is a type of 'CAR T-cell therapy'.
CAR T-cell therapy is a very clever treatment that uses your own body's immune system to fight cancer. It involves taking some of your white blood cells, called T-cells, from your blood. These cells are then sent to a lab where they are specially changed to help them recognise and attack cancer cells more effectively. Once they are ready, these specially trained T-cells are given back to you through a drip.
This particular study is exciting because it uses a new way to make these CAR T-cells closer to where the patient is being treated, known as 'point-of-care manufacturing'. This is an early-stage study (called Phase I/II) to understand if this new treatment is safe, what side effects might happen, and if it could be a helpful option for people with relapsed or refractory CLL or SLL. The study will carefully watch how patients respond to the treatment.
Key takeaways
- This study is for adults with certain blood cancers (CLL/SLL) that have returned or not responded to previous treatments.
- It tests a new type of treatment called CAR T-cell therapy (BCN-CP01).
- It's an early-stage study focused on safety and potential effectiveness.
- The treatment uses your own immune cells to fight cancer.
- Participation involves regular monitoring and hospital visits.
- You can stop participating at any time.
Who may be eligible?
This study is open to adults aged 18 and older. It includes both men and women.
To be considered for this study, you must have been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Importantly, your cancer must have either returned after you've already had treatment, or it must not have gotten better with previous treatments. This is often referred to as 'relapsed or refractory' cancer.
The research team will carry out several checks and tests to make sure that the study treatment is suitable and safe for you, and that you meet all the specific requirements of the study.
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?
- Have you been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)?
- Has your CLL or SLL returned after previous treatment, or did it not get better with previous treatments?
- Are you able to attend regular hospital appointments for monitoring?
What does participation involve?
If you decide to take part in this study, you will first have a number of tests to see if the treatment is suitable for you. If you are eligible, some of your blood will be collected to make the special T-cells for the treatment. You will then receive the BCN-CP01 treatment as a drip into your arm.
Throughout the study, you will have regular hospital visits, especially in the beginning, so the doctors and nurses can closely monitor your health, check for any side effects, and see how you are responding to the treatment. These visits will involve physical examinations, blood tests, and scans. The total duration of your participation in the study, including follow-up visits, will be explained by the study team.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedNetherlands
Common questions
What exactly is CAR T-cell therapy?
It's a treatment where your own immune cells are specially trained in a lab to find and destroy cancer cells in your body.
Why is this study being done?
This study aims to see if a new way of making and giving CAR T-cell therapy (BCN-CP01) is safe and effective for people whose CLL or SLL has come back or not responded to other treatments.
What are CLL and SLL?
They are types of blood cancer that affect white blood cells called lymphocytes.
Will I get better if I join this study?
The study aims to see if the treatment can help, but because it's an early-stage study, we can't guarantee you will get better. We are testing for safety and potential benefits.
Is the treatment painful?
Receiving the treatment involves a drip, similar to a blood transfusion. Any discomfort from tests or side effects will be managed by the medical team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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