A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects with Relapsed/Refractory Large B Cell Lymphoma (LBCL).
This research is a Phase 1/2 study looking into a new treatment for adults with Large B-Cell Lymphoma (LBCL). This is a type of blood cancer where standard treatments haven't been successful. The new treatment involves a special cell therapy called ALLO-501A, which uses specially modified immune cells to fight the cancer, combined with another drug called ALLO-647. The main goal of this study is to carefully check how safe these treatments are and how well they work at shrinking or getting rid of the cancer. Researchers will also be looking at how the body handles these new drugs and how they affect the immune system. This study is an important step in finding new ways to help people with this challenging cancer.
At a glance
What is this study about?
This study is investigating a new approach to treating a type of blood cancer called Large B-Cell Lymphoma (LBCL). This cancer affects certain white blood cells and can be very serious, especially when standard treatments haven't worked or the cancer has returned. The new treatment being tested involves something called CAR T-cell therapy, specifically a product named ALLO-501A. CAR T-cell therapy is a fancy name for a treatment where a patient's own immune cells (T-cells) are collected, modified in a lab to better recognise and fight cancer, and then given back to the patient.
What's different about ALLO-501A is that it's an "allogeneic" CAR T-cell therapy. This means the T-cells come from a healthy donor, not the patient themselves. This could make the treatment quicker and more widely available. The study is also looking at ALLO-647, which is another drug given alongside the CAR T-cell therapy. This drug helps prepare the patient's body for the new T-cells and makes them more effective.
The main purpose of this study, which is in its Phase 1/2 stages, is to understand how safe this combination of treatments is for patients, what kinds of side effects might occur, and how well it works at reducing or eliminating the cancer. Researchers will also be closely watching how the body reacts to these new cells and drugs, which is important for developing better treatments in the future for people with LBCL.
Key takeaways
- New cell therapy (ALLO-501A) for Large B-Cell Lymphoma.
- Specifically for cancer that hasn't responded to previous treatments.
- Cells come from a donor, not the patient.
- Study checks safety and how well the treatment works.
- Includes another drug (ALLO-647) to help the main therapy.
- This is an early-stage study (Phase 1/2).
Who may be eligible?
To join this study, you must be an adult aged 18 or older. We are looking for both men and women to participate.
This study is for people who have Large B-Cell Lymphoma, specifically if your cancer has come back after previous treatments or if those treatments didn't work. Before you can join, the study team will need to check your medical history and carry out some tests to make sure this study is right for you and that you meet all the health 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.
- Are you 18 years old or older?
- Have you been diagnosed with Large B-Cell Lymphoma?
- Has your lymphoma returned or not responded to past treatments?
- Are you able to attend regular hospital visits and appointments?
What does participation involve?
If you decide to take part in this study, you'll be given a combination of new drugs including ALLO-501A and ALLO-647, along with some other medicines to help manage reactions and prevent infections. You will have regular visits to the hospital for various assessments, which will likely include blood tests, physical exams, and scans to monitor your health and how your cancer is responding to the treatment. The research team will explain the full schedule of visits and tests. There will also be follow-up appointments to track your progress after the main treatment period. The total duration of your participation could range from several months to a few years, depending on the study's monitoring plan.
Potential risks and benefits
Locations (2)
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is Large B-Cell Lymphoma?
It's a type of cancer that affects a specific kind of white blood cell, which are part of your immune system. It can grow quickly.
What is CAR T-cell therapy?
It's a treatment where special immune cells are given to you to help your body find and fight cancer cells.
Are the cells used in this treatment from me?
No, in this specific study, the immune cells for the treatment come from healthy donors, not your own body.
What does 'Phase 1/2' mean?
It means the study is in early stages, first checking for safety and the right dose (Phase 1), then looking at how well the treatment works (Phase 2).
Will I get other medications in the study?
Yes, you will receive ALLO-501A and ALLO-647, plus other medications to manage side effects, prevent infections, and prepare your body for treatment.
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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