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CAR T cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes) to treat central nervous system (CNS) lymphoma

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18 and older

Phase 1

1 Location

NCT05625594

Clinical Trial Goal


To find out:
  • The highest dose of CAR T cells that's safe to give
  • If CAR T cells are safe and work well to treat CNS lymphoma 

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have primary or secondary CNS lymphoma
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Cyclophosphamide and fludarabine are drugs that block the growth of cancer 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.

To make CAR T cells, T cells are collected from [you][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 chemotherapy (chemo) with 2 standard drugs:
  • Clyclophosphamide – Given as intravenous (IV) infusions
  • Fludarabine - Given as IV infusions

Then, the CAR T cells are given to you intracerebroventricularly (ICV). ICV is an injection technique that delivers the CD19-CAR T cells directly into the cerebrospinal fluid. 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 15 years.

The Food and Drug Administration (FDA) has not yet approved CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes.

Watch a video about CAR T-Cell Therapy
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Locations


City of Hope Medical CenterRECRUITING

Duarte, California
Tanya Siddiqi, 626-803-3458, tsiddiqi@coh.org

ClinicalTrials.gov record


NCT05625594. First posted on 11/23/22

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