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CAR T cells (brexu-cel) plus the drug, pirtobrutinib, to treat mantle cell lymphoma (MCL) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 2

3 Locations

NCT06553872

Clinical Trial Goal


To find out if CAR T cells (brexu-cel) plus pirtobrutinib, is safe and works well to treat MCL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have MCL that has relapsed or is refractory
  • Do not have lymphoma in your brain or spinal cord
  • Have not been treated with pirtobrutinib for more than 2 months
  • Have not had CAR T-cell therapy 
  • Have not had allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 2 months
  • Have not had autologous (your own cells) BMT in the last 2 months
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Brexu-leucel is a type of CAR T-cell therapy that targets CD19 in certain cells.
CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
Pirtobrutinib is a small molecule inhibitor that blocks BTK in certain cells.

To make CAR T cells, T cells are collected from you by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to you to find and destroy the cancer cells.
 
Before the CAR T-cell infusion, you’ll get:
  • Pirtobrutinib – A pill that you take by mouth 1 time each day for 3 weeks

Then, the CAR T cells are given to you through an IV infusion. The dose of cells you’ll get depends on when you start the trial and how safe it has been.

The clinical trial doctors will watch you closely over 4 years. You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 15 years.

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in combination to treat MCL that has relapsed or is refractory is new and unproven. 

Watch a video about CAR T-Cell Therapy

Contacts


Ruthie Chae, 813-745-3425, ruthie.chae@moffitt.org

Locations


Stanford Cancer CenterNOT_YET_RECRUITING

Stanford, California
Saurabh Dahiya, MD, 650-724-4155

Moffitt Cancer CenterRECRUITING

Tampa, Florida
Ruthie Chae, 813-745-3425, ruthie.chae@moffitt.org

Univ of Miami - Sylvester Comprehensive Cancer CenterRECRUITING

Miami, Florida
Jay Spiegel, MD, 305-243-5302

ClinicalTrials.gov record


NCT06553872. First posted on 8/14/24

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