Clinical Trial Goal
To find out:
- The highest dose of CAR T cells (CD19/CD20/CD22) that's safe to give
- If CAR T cells (CD19/CD20/CD22) are safe and work well to treat leukemia or lymphoma that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years or older
- Have one of the following diseases that has relapsed or is refractory:
- Acute lymphoblastic leukemia (ALL)
- B-cell prolymphocytic leukemia (B-PLL)
- Burkitt lymphoma
- Chronic lymphocytic leukemia (CLL)
- Diffuse large B-cell lymphoma (DLBCL)
- Follicular lymphoma
- Mantle cell lymphoma (MCL)
- Other B-cell non-Hodgkin lymphoma (NHL)
- Small lymphocytic lymphoma (SLL)
- Have cancer cells that have CD19 (CD19+), CD20 (CD20+) or CD22 (CD22+) markers. Your doctor can tell you this
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 2 months
- Do not have active graft versus host disease (GVHD)
- Do not have lymphoma cells in your brain or spinal cord
- 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/CD20/CD22) target CD19, CD20 and CD22 on certain cells.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer 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 chemo with 2 standard drugs:
CAR T cells (CD19/CD20/CD22) target CD19, CD20 and CD22 on certain cells.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer 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 chemo with 2 standard drugs:
- Cyclophosphamide - Given as intravenous (IV) infusions 1 time
- Fludarabine - Given as IV infusions 3 times
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 1 year. 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 15 years.
The Food and Drug Administration (FDA) has not yet approved CAR T(CD19/CD20/CD22).
Watch a video about CAR T-Cell Therapy
YMVkPF1tUG8
The Food and Drug Administration (FDA) has not yet approved CAR T(CD19/CD20/CD22).
Watch a video about CAR T-Cell Therapy
YMVkPF1tUG8
Contacts
The Ohio State University Comprehensive Cancer Center, 800-293-5066, OSUCCCClinicaltrials@osumc.edu
Locations
Nationwide Children's HospitalRECRUITING
Columbus, Ohio
Contacts:
- Kennedy Thompson, 614-722-5043, Kennedy.thompson@nationwidechildrens.org
- Lori Jewell, BA, 614-722-6576, Lori.Jewell@nationwidechildrens.org
Ohio State University Comprehensive Cancer CenterRECRUITING
Columbus, Ohio
Sumithira Vasu, MD, 614-293-8197, Sumithira.Vasu@osumc.edu
Sponsors
collaborator: National Cancer Institute (NCI), lead: Sumithira Vasu
