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CAR T cells (LV20.19), in combination with pirtobrutinib, to treat B-cell non-Hodgkin lymphoma (NHL) that has come back (relapsed) or not gotten better with treatment (refractory)

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Phase 1

1 Location

NCT05990465

Clinical Trial Goal


To find out if the combination of pirtobrutinib and LV20.19 is safe and works well to treat B-cell NHL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 - 81 years old
  • Have B-cell NHL. Some examples include:
    • Burkitt lymphoma 
    • Diffuse large B-cell lymphoma (DLBCL)
    • Follicular lymphoma
    • Mantle cell lymphoma (MCL)
    • Marginal zone lymphoma (MZL)
  • Do not have lymphoma in your brain or spinal cord
  • Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
  • Have not had a CAR T-cell therapy that targets CD19 or CD20 in the last 3 months. Your doctor can tell you this
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


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.
LV20.19 is a type of CAR T-cell therapy that targets CD19 and CD20 on certain 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 2 weeks

Next, you'll get chemotherapy (chemo) with standard drugs. 

Then, the CAR T cells are given to you through an IV infusion.

The clinical trial doctors will watch you closely over 1 year. 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 pirtobrutinib to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).  The FDA has not yet approved LV20.19. 

Watch a video about CAR T-Cell Therapy

Contacts


Medical College of Wisconsin Cancer Center Clinical Trials Office, 866-680-0505, cccto@mcw.edu

Locations


Froedtert & the Medical College of WisconsinRECRUITING

Milwaukee, Wisconsin
Nirav Shah, MD, 414-805-4400, nishah@mcw.edu

ClinicalTrials.gov record


NCT05990465. First posted on 8/14/23

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