A drug, acalabrutinib, plus CAR T cells (CD19) to treat mantle cell lymphoma (MCL) that has come back (relapsed) or has not gotten better with treatment (refractory)

To find out if the combination of acalabrutinib and CAR T cells is safe and works well to treat MCL that has relapsed or is refractory

Acalabrutinib is a small molecule inhibitor that blocks BTK 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. This CAR T-cell therapy targets CD19 on 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 continue treatment with acalabrutinib, a pill that you take by mouth 2 times each day for 5 days.

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

You'll continue taking acalabrutinib for 6 months.

Then, you may get a second IV infusion of the CAR T cells. The clinical trial doctors will decide who gets this based on how the lymphoma has responded to the other treatment.

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 acalabrutinib to treat MCL. The FDA has not yet approved this CAR T-cell therapy to treat MCL.

Watch a video about CAR T-Cell Therapy