A Pediatric Trial of Genetically Modified Autologous T-Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia
Our new study uses genetically modified autologous T-cells to treat patients with relapsed acute lymphoblastic leukemia (ALL). This study is relevant for patients with B-cell ALL, not other leukemias or other pediatric cancers. The goal of this Phase I trial is to assess the feasibility and safety of autologous cellular immunotherapy in patients with relapsed ALL.
This study is currently open but has limited openings, so very few patients will be enrolled.
Enrollment began in December, 2012. The study will begin with enrolling young adults, aged 18–26, and will open up to younger patients with successive cohorts. The study may enroll up to 15–26 participants.
How the Trial Works
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:
- 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.
- 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 and, if necessary, this molecule will serve as a means of potentially eliminating the reprogrammed T-cells using the monoclonal antibody cetuximab.
- The reprogrammed cells are reintroduced to the body through an IV infusion – and the hope is for the cells to immediately go to work, hunting down and eliminating the cancer cells.
You can find more details on this clinical trial on Clinicaltrials.gov.
It is important to note that this therapy is in a very early phase of safety testing. We regret not being able to offer this study to larger numbers of patients, but this study 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 Seattle Children’s we are treating some of the sickest kids in the region with this trial. As with any trial, we will constantly evaluate outcomes to determine appropriate dosing levels that allow us to continue through each cohort and finish the trial.
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 Seattle 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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