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Clinical Trials

Phase I Leukemia (ALL) Cancer Trials

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Pediatric Trials of Genetically Modified T Cells Directed Against CD19 for Relapsed CD19+ Leukemia

Our two open studies use genetically modified autologous T cells to treat patients with relapsed acute lymphoblastic leukemia (ALL) before and after a bone marrow transplant. Studies are relevant for patients with CD19+ leukemia, not other leukemias or other pediatric cancers. The goal of our Phase I trials is to assess the feasibility and safety of patient-derived cellular immunotherapy in patients with relapsed ALL.

Our studies are currently open but have limited openings, so very few patients will be enrolled.

How the Trials Work

Cellular immunotherapy is intended to reprogram the body’s infection-fighting T cells, enabling them to seek out and destroy cancer cells wherever they are hiding in the body. The steps in this process are:

  1. A blood sample from the patient is drawn at Seattle Children’s Hospital and received into the Therapeutic Cell Production Core (TCPC), where immune cells called T cells are purified, reprogrammed with recombinant DNA and grown to billions of cells under FDA guidelines.
  2. The reprogramming instructs the T cells to make an artificial receptor that acts like a Velcro molecule, allowing the T cells to recognize and attack cancer cells as if they were fighting an infection. In addition, the reprogramming instructs the T cells to express a marker molecule that will allow the research team to track the T cells. If necessary, this molecule will serve as a means of potentially eliminating the reprogrammed T cells using the monoclonal antibody cetuximab.
  3. The reprogrammed cells are reintroduced to the body through an IV infusion in the hope that they will immediately go to work, hunting down and eliminating the cancer cells.

You can find more details of these clinical trials on Clinicaltrials.gov.

Special Considerations

It is important to note that this therapy is in a very early phase of safety testing. We regret not being able to offer these studies to larger numbers of patients, but these studies can only enroll a few patients. As with all research, getting to a cure will involve many steps, and our research program is focused on fully developing this therapy to its safest and most effective iteration.

At Children’s we are treating some of the sickest kids in the region with these trials. As with any trials, we will constantly evaluate outcomes to determine appropriate dosing levels that allow us to continue through each cohort and finish the trials.

How to Contact Us

  • To schedule an appointment or request a second opinion, call 206-987-2106 or, toll-free, 866-987-2000.
  • For more information about clinical trials at Children’s, visit our Clinical Trials page.
  • Learn more about the Ben Towne Center for Childhood Cancer Research and the Jensen Lab.

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Administrative Assistant
Leanne Rubin
206-884-2129