Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
This research study is looking at a new treatment called Allo-QuadCAR01-T for people with certain B-cell cancers that haven't responded to other treatments, such as lymphoma. Unlike standard CAR-T therapies that use a patient's own cells, this new approach uses cells from a healthy donor. This means the treatment could be ready more quickly and might be less expensive. The therapy is designed to attack cancer cells by targeting two specific markers, CD19 and CD20, which scientists hope will make it more effective and reduce the chance of the cancer coming back. The study will first check if the treatment is safe and then see how well it works, especially in people with a type of lymphoma called diffuse large B-cell lymphoma. Around 160 patients will take part, receiving one treatment after some preparation chemotherapy, and will be followed for many years.
At a glance
What is this study about?
This study is about a new type of treatment called Allo-QuadCAR01-T for people with difficult-to-treat B-cell cancers, such as certain lymphomas. These cancers can be very challenging, and sometimes standard treatments don't work or stop working. This new therapy is a form of CAR-T cell therapy, which uses specially modified immune cells to find and destroy cancer.
What makes Allo-QuadCAR01-T different is that it's an "off-the-shelf" treatment. This means the cells come from a healthy donor and are ready to use when needed. Current CAR-T therapies usually involve taking a patient's own immune cells, sending them away to be modified, and then giving them back – a process that can take weeks. Using donor cells could make the treatment much quicker and potentially more affordable, offering a new option for patients who need treatment fast.
The therapy is designed to attack cancer cells in a smart way. Cancer cells often have specific 'markers' on their surface. Allo-QuadCAR01-T is made to target two different markers, called CD19 and CD20, at the same time. Scientists hope that targeting two markers will make the treatment more powerful and reduce the chances of the cancer coming back. The study's main goals are to make sure the treatment is safe and to find out how effective it is in shrinking or getting rid of cancer, especially in a type of lymphoma called diffuse large B-cell lymphoma (DLBCL).
Key takeaways
- New 'off-the-shelf' donor cell therapy for hard-to-treat B-cell cancers.
- Targets two cancer markers (CD19 & CD20) for potentially better results.
- Aims to be faster to deliver and potentially less costly than current CAR-T.
- Early phases checking safety and how well it shrinks cancer.
- Patients followed for up to 15 years to understand long-term effects.
Who may be eligible?
To join this study, you generally need to be at least 18 years old and have a B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia that has either come back or not responded to at least two previous treatments. You must be well enough to carry out your daily activities with ease and have healthy organs like your heart, liver, and kidneys. An important requirement is that your body's specific tissue type (called HLA) must match the donor cells being used in the therapy.
There are also some reasons why you might not be able to join. For example, if you have certain active infections, significant brain involvement from your cancer, or have had certain other cell therapies or transplants recently, you might not be eligible. If you have severe allergies to certain medicines, or some specific medical conditions such as active HIV or recent heart problems, you also wouldn't be able to take part.
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 or older?
- Do you have certain B-cell cancers that haven't responded well to at least two previous treatments?
- Are you generally well enough to go about your daily life?
- Do you have healthy organ function (heart, liver, kidneys)?
- Have you not had a recent stem cell transplant or significant active infection?
What does participation involve?
If you decide to take part in this study, you will first go through a screening process to make sure the treatment is right for you. If you qualify, you will receive some chemotherapy, typically for a few days, to prepare your body for the new cells. After this preparation, you will receive a single infusion (like a drip) of the Allo-QuadCAR01-T cells. You will stay in hospital for a period after the infusion so the medical team can closely monitor you for any effects of the treatment.
After leaving the hospital, you'll have regular follow-up visits to check your health, see how the treatment is working, and manage any side effects. These visits will become less frequent over time. The researchers plan to follow patients for a very long time, up to 15 years, to understand the long-term effects of the treatment. The total duration of your active involvement with frequent assessments will depend on your individual response and safety, but the long-term follow-up for health updates is a key part of the study.
Potential risks and benefits
Locations (13)
- University of ChicagoVerified postcodeChicago, United States· Not yet recruiting
- Northwestern UniversityVerified postcodeEvanston, United States· Not yet recruiting
- Brown University HealthVerified postcodeProvidence, United States· Not yet recruiting
- Sarah Cannon Research InstituteVerified postcodeNashville, United States· Recruiting
- MD Anderson Cancer CenterVerified postcodeHouston, United States· Not yet recruiting
- Universitätsklinikum UlmVerified postcodeUlm, Germany· Recruiting
- Universitätsklinikum ErlangenVerified postcodeErlangen, Germany· Recruiting
- Klinikum der Universität MünchenVerified postcodeMunich, Germany· Not yet recruiting
- Universitätsklinikum MarburgVerified postcodeMarburg, Germany· Not yet recruiting
- Uniklinikum ErlangenVerified postcodeEssen, Germany· Not yet recruiting
- Universitätsklinikum DresdenVerified postcodeDresden, Germany· Recruiting
- Charité Universitätsmedizin BerlinVerified postcodeBerlin, Germany· Recruiting
Common questions
What is 'off-the-shelf' CAR-T therapy?
'Off-the-shelf' means the treatment cells come from a healthy donor and are ready to use, rather than being made from your own cells, which saves time.
What types of cancer is this study for?
This study is for people with certain types of B-cell cancers, like lymphomas or chronic lymphocytic leukemia, that have been difficult to treat with other therapies.
How long will I be followed in this study?
Researchers want to follow patients for a long time, up to 15 years, to understand the long-term effects of this new treatment.
What is the main goal of the study?
The main goal is to check how safe the new treatment is and how well it works at getting rid of the cancer, especially by Week 13 after the treatment.
Will I receive other treatments during the study?
You will receive certain chemotherapy medicines to prepare your body before you get the main study treatment, the Allo-QuadCAR01-T cell infusion.
How to find out more
Antje Warth, Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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