A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
This study is a clinical trial looking at a new treatment called Prizlo-Cel. It's for adults whose B-cell non-Hodgkin lymphoma has either come back after previous treatments or hasn't responded well to them. It's also for some people with a specific type of high-risk lymphoma called diffuse large B-cell lymphoma. Prizlo-Cel is a type of cell therapy where doctors take some of your own immune cells, modify them in a lab to better fight cancer, and then give them back to you. The main goal of this study is to find out if Prizlo-Cel is safe and if it can effectively treat these types of lymphoma. This research is important because it could lead to new options for people with difficult-to-treat lymphomas.
At a glance
What is this study about?
This study is investigating a new and advanced treatment for certain types of lymphoma, which is a cancer that starts in the white blood cells called lymphocytes. Specifically, it's focusing on B-cell non-Hodgkin lymphoma, which is the most common type. The new treatment being tested is called Prizloncabtagene autoleucel, or Prizlo-Cel for short. This is a special type of 'living drug' or cell therapy, where your own immune cells, called T-cells, are taken from your blood and then specially trained in a lab to recognise and attack cancer cells. Once they're ready, these modified cells are given back to you.
The study is designed to explore how safe and effective Prizlo-Cel is. It's aimed at adults whose lymphoma has either come back after past treatments (what doctors call 'relapsed') or hasn't responded well to those treatments ('refractory'). It also includes some people with a specific type of aggressive lymphoma called diffuse large B-cell lymphoma, especially those whose cancer is considered high-risk. This trial is in different stages (Phase 1b and Phase 2), which means the researchers are carefully establishing the correct dose and then testing if the treatment works.
Finding new ways to treat lymphoma is really important, especially for people who haven't had success with standard treatments. By taking part in this study, volunteers are helping scientists learn more about Prizlo-Cel and hopefully contribute to developing new and better ways to fight lymphoma in the future. The information gathered will help us understand if this new cell therapy could become a valuable option for patients.
Key takeaways
- This study evaluates a new cell therapy (Prizlo-Cel) for specific types of lymphoma.
- It's designed for adults whose B-cell non-Hodgkin lymphoma is difficult to treat.
- Prizlo-Cel uses your own immune cells, specially trained to fight cancer.
- The study aims to understand if the treatment is safe and effective.
- Participation involves cell collection, treatment, and regular follow-up appointments.
- You can discuss with your doctor if this trial might be a suitable option for you.
Who may be eligible?
To join this study, participants must be at least 18 years old. Doctors will need to confirm that your lymphoma cells have specific markers (proteins called CD19 and/or CD20) on their surface, as the treatment is designed to target these. Also, your lymphoma must be a B-cell type and either have come back or not responded well to at least two previous treatments. You must also have measurable signs of the disease and be generally well enough to participate, as assessed by a doctor.
There are also some reasons why you might not be able to join. For example, if you've had certain serious heart problems, a stroke, or a major blood clot in the past six months, you might not be eligible. Also, if you have certain brain or nerve conditions, active infections, or specific liver illnesses, the study might not be suitable for you. This is to make sure the study is as safe as possible for everyone involved.
- Are you 18 years old or older?
- Has your lymphoma been confirmed as CD19 and/or CD20 positive?
- Has your lymphoma either returned or not responded well to at least two prior treatments?
- Do you have measurable signs of your lymphoma?
- Are you generally well enough for a clinical trial (ECOG performance status 0-2)?
- Have you *not* had serious heart problems, stroke, or major blood clots in the last 6 months?
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, the first step involves a process called 'apheresis'. This is where some of your blood is taken, and your T-cells (a type of immune cell) are separated and collected. This is similar to donating blood, but only your T-cells are kept. These cells are then sent to a special lab where they are modified to become Prizlo-Cel.
Once your Prizlo-Cel cells are ready, you will receive them through an infusion, which is like a drip into your vein. Before and after this infusion, you will have regular hospital visits for check-ups. These visits will include physical examinations, blood tests, and scans (like CT scans) to see how you are responding to the treatment and to monitor for any side effects. The exact number and frequency of visits will depend on how you are doing, but there will be frequent checks in the beginning, becoming less often over time. The total duration of follow-up will vary, but participants in these types of studies are often monitored for several years to track long-term safety and effectiveness.
Potential risks and benefits
Locations (32)
- City of HopeDuarte, United States· Recruiting
- Colorado Blood Cancer InstituteDenver, United States· Recruiting
- University of Iowa Hospital and ClinicsIowa City, United States· Recruiting
- University of Kentucky Medical CenterLexington, United States· Recruiting
- Rutgers Cancer Institute of New JerseyPiscataway, United States· Recruiting
- Levine Cancer InstituteCharlotte, United States· Recruiting
- University Hospitals Cleveland Medical CenterCleveland, United States· Recruiting
- University of Pittsburgh Medical CenterPittsburgh, United States· Recruiting
- Greco Hainesworth Tennessee Oncology Centers for ResearchNashville, United States· Recruiting
- Sarah Cannon Research InstituteNashville, United States· Recruiting
- St. David's South Austin Medical CenterAustin, United States· Recruiting
- MD Anderson Cancer CenterHouston, United States· Recruiting
+20 more sites — see the official record for the full list.
Common questions
What is Prizlo-Cel?
It's a new type of cell therapy that uses your own specially modified immune cells to fight cancer.
Who is this study for?
It's for adults with specific types of B-cell non-Hodgkin lymphoma that has returned or is hard to treat, or some high-risk diffuse large B-cell lymphoma.
What does 'relapsed or refractory' mean?
It means your cancer has come back after treatment or hasn't responded well to previous treatments.
Will I have to stay in the hospital?
You will likely need to be in the hospital for the cell infusion and for close monitoring afterwards, with regular outpatient visits following that.
Can I leave the study at any time?
Yes, you can choose to stop participating in the study whenever you want to, without any impact on your medical care.
How to find out more
Study Contact, M.D.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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