Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

This research study is looking at a new type of treatment called rapcabtagene autoleucel (pronounced rah-pca-tab-gene auto-loo-sell), also known as YTB323, for several kinds of blood cancer. These include Chronic Lymphocytic Leukaemia (CLL), certain types of Large B-cell Lymphoma (DLBCL, LBCL), and Acute Lymphoblastic Leukaemia (ALL). The study has two main parts: Phase 1 checks if the treatment is safe and finds the right dose. Phase 2 then looks at how well it works. For some cancers, like CLL, it's being tested alongside another drug called ibrutinib. For others, like certain lymphomas and leukaemias, it's being given on its own. The goal is to see if this new cell therapy could be a good option for people who haven't responded to previous treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

217

Start

26 Jun 2019

Estimated completion

31 May 2028

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diffuse Large B-cell Lymphoma Acute Lymphoblastic Leukemia Large B-cell Lymphoma

What is this study about?

This study is testing a new treatment called rapcabtagene autoleucel. This is a type of cell therapy, which means it uses your own body's cells, changed in a laboratory, to fight cancer. The researchers want to find out if this therapy is safe and effective for people with specific blood cancers, including different forms of lymphoma and leukaemia. They'll also be trying to find the best dose to give.

There are two main parts to the study. The first part, called Phase 1, is like a careful first step. It focuses on safety and finding the best amount of the treatment to give. Once that's figured out, the study moves to Phase 2, which looks more closely at how well the treatment actually works against the cancer. For some types of leukaemia, this new cell therapy will be tested alongside another existing medication called ibrutinib. For other types of lymphoma and leukaemia, it will be given on its own.

Essentially, this study is about exploring a new way to treat these specific cancers, especially for patients who haven't had success with other treatments. By carefully studying how rapcabtagene autoleucel works, doctors hope to learn if it can become a helpful new option for people needing treatment.

Key takeaways

This study is testing a new cell therapy for specific blood cancers.
It's for people who have already tried other treatments.
The study aims to check safety and how well the treatment works.
Some patients might also receive another drug called ibrutinib.
Participation involves close monitoring with tests and scans.

Who may be eligible?

To join this study, people generally need to be aged between 18 and 100 years old. You'll need to have been diagnosed with one of the specific types of blood cancer being studied, such as Chronic Lymphocytic Leukaemia (CLL), certain forms of Large B-cell Lymphoma (DLBCL, LBCL), or Acute Lymphoblastic Leukaemia (ALL).

For most parts of the study, you would have already tried other treatments that either didn't work or stopped working. For example, some people with CLL would have been on ibrutinib for at least six months. People with certain lymphomas would have had two or more rounds of chemotherapy. If you have a specific type of high-risk Large B-cell Lymphoma, you would have had two cycles of a standard treatment and your scans would show that the treatment is either keeping the cancer stable or reducing it a bit.

There are also reasons why someone might not be able to join. For instance, if you've already had certain other cell therapies or specific organ transplants, you might not be eligible. If your cancer has spread to your brain or spinal cord, that would also usually exclude you. The study team will review all your medical information carefully to see if this study is the right fit for you.

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 to 100 years old?
Do you have CLL, specific DLBCL/LBCL, or ALL?
Have you already had other treatments for your cancer?
Is your ECOG performance status 0-1 (for ALL and DLBCL) or 0-2 (for LBCL)?
Have you previously had a stem cell transplant from a donor (not your own cells)? (If yes, you might not be eligible)
Has your cancer spread to your brain or spinal cord? (If yes, you might not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first go through a screening process to make sure the study is right for you. This will involve various tests and appointments. Depending on which group you're in, you might receive rapcabtagene autoleucel on its own, or in combination with the drug ibrutinib.

The treatment itself involves carefully preparing your own cells and then giving them back to you. The study team will monitor you very closely throughout this process and for a period afterwards to check for any side effects and see how the treatment is working. This will mean regular hospital visits for check-ups, blood tests, and scans. The exact number of visits and tests will depend on your specific situation within the study. The total time you're involved in the study will vary, but you can expect long-term follow-up to track your health.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. The main potential benefit of this study is that you might receive a new treatment that could help your cancer, especially if other treatments haven't worked or stopped working. However, this treatment is still in development, so there's no guarantee it will be effective for you. As with any medical treatment, there are potential side effects and risks, which the study team will explain in detail. These can range from mild to serious, and the researchers will be carefully monitoring you for any of these. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

University of California LA
Verified postcode
Los Angeles, United States
Stanford University Medical Center
Verified postcode
Stanford, United States
H Lee Moffitt Cancer Center and Research Institute
Verified postcode
Tampa, United States
Uni of Chi Medi Ctr Hema and Onco
Verified postcode
Chicago, United States
University of Kansas Cancer Center
Verified postcode
Westwood, United States
Mass Gen Hosp Cancer Center
Verified postcode
Boston, United States
University of Pennsylvania Clinical
Verified postcode
Philadelphia, United States
Tennessee Oncology
Verified postcode
Nashville, United States
Sarah Cannon Research Institute
Verified postcode
Nashville, United States
St Davids South Austin Medical Ctr
Verified postcode
Austin, United States
Uni Of TX MD Anderson Cancer Cntr
Verified postcode
Houston, United States
Medical College of Wisconsin
Verified postcode
Milwaukee, United States

Common questions

What is rapcabtagene autoleucel?

It's a new type of cell therapy that uses your own specially modified cells to fight cancer.

What types of cancer is this study for?

It's for certain blood cancers, including specific types of Chronic Lymphocytic Leukaemia (CLL), Large B-cell Lymphoma (DLBCL, LBCL), and Acute Lymphoblastic Leukaemia (ALL).

Do I need to have tried other treatments first?

Yes, for most parts of this study, you would have already received other treatments for your cancer that were not successful or stopped working.

Will I get ibrutinib too?

Some patients, particularly those with CLL, might receive ibrutinib alongside the new cell therapy, while others will get the cell therapy on its own.

How long does the study last?

The study involves initial treatment followed by a period of close monitoring and long-term follow-up, so the total duration can be quite long.