Clinical Trial Goal
To find out:
- The highest dose of CAR T cells (CD19/CMV-specific) that's safe to give with CMV vaccine
- If the combination of CAR T cells (CD19/CMV-specific) and CMV vaccine is safe and works well to treat B-cell NHL that has relapsed or is refractory in patients who have CMV
You may be able to join this trial if you:
- Are 18 years or older
- Are Cytomegalovirus (CMV) positive
- Have B-cell NHL that has relapsed or is refractory. Some examples include:
- Burkitt lymphoma
- Chronic lymphocytic leukemia (CLL)
- Diffuse large B-cell lymphoma (DLBCL)
- Follicular lymphoma
- Mantle cell lymphoma (MCL)
- Small lymphocytic lymphoma (SLL)
- Transformed NHL
- Have disease/cancer cells with mutation/marker CD19. Your doctor can tell you this
- Do not have lymphoma in your brain or spinal cord
- Have not had an autologous (your own cells) or an allogeneic (cells from a donor) blood or marrow transplant (BMT)
- 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.
CAR T cells (CD19/CMV-specific) target CD19 and CMV.
Carmustine, cytarabine, etoposide and melphalan are chemotherapy drugs that block the growth of cancer cells.
CMV vaccine is a vaccine that researchers believe may reduce the risk of developing complications related to CMV infection.
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:
Chemo with 4 standard drugs:
CAR T cells (CD19/CMV-specific) target CD19 and CMV.
Carmustine, cytarabine, etoposide and melphalan are chemotherapy drugs that block the growth of cancer cells.
CMV vaccine is a vaccine that researchers believe may reduce the risk of developing complications related to CMV infection.
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:
Chemo with 4 standard drugs:
- Carmustine
- Cytarabine
- Etoposide
- Melphalan
Then, you'll get:
- Autologous BMT - Your blood-forming cells will be collected from you by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. On transplant day, your own blood-forming cells are given back to you through an IV infusion.
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.
After you receive the CAR T cells, you'll get:
- CMV vaccine - A shot given into your muscle
The clinical trial doctors will watch you closely. 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 carmustine, cytarabine, etoposide and melphalan. The FDA has not yet approved CAR T cells (CD19/CMV-specific) or CMV vaccine.
Watch a video about CAR T-Cell Therapy
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Locations
Sponsors
collaborator: National Cancer Institute (NCI), lead: City of Hope Medical Center
