Clinical Trial Goal
To find out if cema-cel is safe and works well to treat LBCL with MRD
You may be able to join this trial if you:
- Are 18 years old or older
- Have one of the following:
- Diffuse large B-cell lymphoma (DLBCL)
- High-grade B-cell lymphoma
- Primary mediastinal B-cell lymphoma (PMBCL)
- Have been treated with first line therapy, such as R-CHOP chemotherapy (chemo), and minimal residual disease (MRD) . 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
ALLO-647 is a monoclonal antibody that targets CD52 on 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.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
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.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – cema-cel
- Group 2 – cema-cel plus ALLO-647
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
To make CAR T cells, T cells are collected from a donor 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 the following to prepare your body for the CAR T cells:
- ALLO-647 - Group 2 only - Given as an intravenous (IV) infusion
- Cyclophosphamide – Given as an IV infusion
- Fludarabine - Given as an IV infusion
Then, the CAR T cells (cema-cel) are given to you through an IV infusion.
You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has approved cema-cel, cyclophosphamide and fludarabine for the treatment of LBCL. ALLO-647 has not been FDA approved.
Watch a video about CAR T-Cell Therapy
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Locations
Sponsors
collaborator: Foresight Diagnostics, Inc., lead: Allogene Therapeutics
