A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies
This study is exploring a new medicine called ALETA-001 for people in the UK who have specific types of B-cell lymphoma, such as diffuse large B-cell lymphoma or mantle cell lymphoma. These are cancers that affect a type of white blood cell. Participants in this study will have already received a particular type of treatment called CD19 CAR T-cell therapy. The main goals are to understand how safe ALETA-001 is, how well it works, and how the body handles it. It's split into two main parts: an early phase to find the best dose and timing, and a later phase to check its effects more thoroughly. This is the first time this medicine is being tested in humans.
At a glance
What is this study about?
This study is testing a new medicine called ALETA-001, which is designed to help your body fight certain types of B-cell lymphoma. These are cancers that affect a type of white blood cell called B-cells. The study is specifically for people who have already been treated with a special type of cell therapy called CD19 CAR T-cell therapy.
The main aim of this research is to see if ALETA-001 is safe to use and how well it works. It's also looking at how often and in what dose the medicine should be given. This is an important step because it's the first time this particular medicine is being given to people. The study is divided into two parts: the first part focuses on finding the safest dose and best way to give the medicine, and the second part will then look more closely at its safety and how effective it is.
Researchers hope that ALETA-001 could potentially be a helpful treatment option for people with B-cell lymphomas who have already had CAR T-cell therapy, especially if their cancer hasn't responded well or has come back. By participating, you could help us learn valuable information about this new treatment.
Key takeaways
- This study is for people with certain B-cell lymphomas who have already had CAR T-cell therapy.
- It's testing a new medicine called ALETA-001 for safety and effectiveness.
- Participation involves receiving ALETA-001 through a drip every two weeks.
- Regular health checks and tests are part of the study monitoring.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
This study is looking for people aged 16 or older who have been diagnosed with certain types of B-cell lymphoma, like diffuse large B-cell lymphoma or mantle cell lymphoma. You would need to have already received a treatment called anti-CD19 CAR T-cell therapy.
Depending on which part of the study you might join, there are some differences in criteria. For some, your cancer would need to show signs of not fully responding or returning after CAR T-cell therapy. For others, you would be joining before starting your CAR T-cell therapy, having been approved for it by a specialist panel.
There are also general health requirements, such as your overall physical ability, and that you do not have other serious health problems that might interfere with the study. The study team will check your medical history and conduct tests to make sure you're a good fit.
- Are you 16 years old or older?
- Do you have a confirmed diagnosis of B-cell non-Hodgkin lymphoma?
- Have you already received anti-CD19 CAR T-cell therapy?
- Are you generally well enough to participate in a study of this kind?
- Are your heart and lung functions within healthy ranges?
- Are you willing and able to cooperate with study procedures and follow-up?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, ALETA-001, through a drip into your vein (intravenous infusion) once every two weeks. The exact number of visits and tests will depend on which part of the study you are in, but they will involve regular check-ups, blood tests, and scans to monitor your health and how the treatment is working. The first part of the study will help determine the best dose and timing for future participants. The total duration of your participation will depend on your response to the treatment and the study plan, but there will be follow-up appointments even after treatment stops.
Potential risks and benefits
Locations (7)
- University Hospital Birmingham NHS Foundation TrustBirmingham, United Kingdom· Recruiting
- Cambridge University HospitalsCambridge, United Kingdom· Recruiting
- St James's University HospitalLeeds, United Kingdom· Recruiting
- University Hospital London HospitalLondon, United Kingdom· Recruiting
- Manchester Royal InfirmaryManchester, United Kingdom· Recruiting
- The Christie HospitalManchester, United Kingdom· Recruiting
- Royal Marsden HospitalSutton, United Kingdom· Not yet recruiting
Common questions
What is a B-cell malignancy?
It's a type of cancer that affects specific white blood cells called B-cells, which are part of your immune system. Lymphoma is a common type of B-cell malignancy.
What is CAR T-cell therapy?
CAR T-cell therapy is a type of treatment where your own immune cells are specially modified in a lab to better find and kill cancer cells.
What does 'Phase I/II' mean?
Phase I is about checking if a new medicine is safe and finding the best dose. Phase II then looks more closely at how well it works and if it has any side effects.
Will I know if I'm getting ALETA-001?
Yes, this is an 'open-label' study, which means both you and the study team will know that you are receiving ALETA-001.
What if I experience side effects?
The study team will closely monitor you throughout the trial. If you experience any side effects, they will provide appropriate medical care and guidance.
How to find out more
Alka Lal
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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