Immunotherapy Integration Hub

Meet Us

Our Vision

We are committed to transforming the way pediatric cancers are treated by speeding up progress toward immunotherapies that can cure the disease without the long-term effects that diminish survivors’ quality of life.

Cancer Immunotherapy Research at Seattle Children’s

Seattle Children’s is an international leader in the effort to better treat cancer in children, adolescents and young adults by equipping the immune system with the ability to recognize cancer cells as targets. This type of therapy is called immunotherapy and works differently than using traditional radiation or chemotherapy treatments. Immunotherapy includes ways to activate and increase the number of anticancer immune cells within the body.

Our most exciting advances have featured chimeric antigen receptor (CAR) T cells. Our Immunotherapy Integration Hub (IIH) – a department of Seattle Children’s Research Institute – has made fundamental contributions to the establishment of this approach by arming a child’s immune system with cancer-fighting CAR T cells, which are engineered to hunt down and destroy cancer cells in the body.

We have the most comprehensive CAR T-cell immunotherapy research program for pediatric patients in the nation, meaning we offer clinical trials of CAR T cells for more types of pediatric cancer than any other facility. We currently have nine active and enrolling CAR T-cell immunotherapy clinical trials at Seattle Children’s. Several of these trials are also available at a few clinical sites across the country.

To date, we have had more than 200 enrollments in our CAR T-cell immunotherapy clinical trials, bringing potentially lifesaving treatments to patients who would otherwise be out of treatment options.

Through this research, we are continuously learning about how CAR T cells fight different types of cancers. We currently provide treatments for a wide range of recurrent or refractory pediatric cancers, including:

  • Acute leukemia or lymphoma
  • Brain and spinal cord (central nervous system) tumors
  • Solid tumors

What is the Immunotherapy Integration Hub at Seattle Children’s?

Seattle Children’s IIH is a team that brings together all of the resources and expertise needed to develop new immunotherapies for pediatric cancer. This includes:

  • Laboratory-based research to find novel ways to target tumors
  • Development, implementation and management of clinical trials
  • Correlative laboratory studies to investigate the impact of the therapies on patients and to provide feedback to the research team

Immunotherapy products are manufactured in Seattle Children’s Therapeutics Cell Manufacturing facility.

How the Immunotherapy Integration Hub Works

The IIH’s Therapeutics Innovation Core (TIC) is our laboratory research and development team focused on creating new CAR T-cell immunotherapy treatments. Our Correlative Studies Laboratory (CSL) within the TIC processes many of the trial-related correlative specimens needed to meet the requirements of the clinical trial protocols. By evaluating patient samples in-house, the CSL team provides real-time data to clinical investigators and researchers in the TIC, creating an essential feedback loop to support trial development and the design of more effective therapies.

Once we develop the CAR T-cell products, our Immunotherapy Coordinating Center (ICC) then designs a clinical research study for each new treatment, including developing the trial protocol and obtaining authorization for an investigational new drug (IND) with the U.S. Food and Drug Administration (FDA). New studies (phase 1) are first opened for enrollment by the clinical research team at Seattle Children’s Cancer and Blood Disorders Center (CBDC). Additional clinical sites may collaborate with us if the trial transitions to phase 2.

For patients enrolled in our clinical trials, cell products are manufactured at our on-site TCPC, one of very few pediatric-dedicated facilities in the U.S. that follows the FDA’s Good Manufacturing Practices for making therapeutic cell products designated for early phase IND clinical trials. The TCPC works closely with the TIC during development and with the clinical team at the clinical trial sites as they prepare the patient for treatment.

Seattle Children’s is also a founding member of CureWorks – an international collaborative of leading academic children’s hospitals across North America determined to accelerate the discovery and development of new cures for pediatric cancer. Visit the CureWorks website to learn more.

What makes Seattle Children’s Immunotherapy Integration Hub unique?

  • Seattle Children’s has the largest, broadest CAR T-cell immunotherapy program for pediatric patients in the nation. This means we treat more types of pediatric cancer using CAR T-cell treatment than any other facility.

    Currently, we have developed and manufactured CAR T-cell treatments and launched clinical trials for a wide range of recurrent or refractory pediatric cancers, including:

    • Acute leukemia or lymphoma
      • PLAT-02: A Phase 1/2 Feasibility and Safety Study of CD19-CAR T-Cell Immunotherapy for CD19+ Leukemia
      • PLAT-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22-CAR T-Cell Immunotherapy for CD19+CD22+ Leukemia and Lymphoma
    • Brain and spinal cord (central nervous system) tumors
      • BrainChild-01: CAR T-Cell Therapy for Brain and Central Nervous System Tumors Clinical Trial
      • BrainChild-02: Phase 1 Study of EGFR806-Specific CAR T-Cell Locoregional Immunotherapy for EGFR-Positive Recurrent or Refractory Pediatric Central Nervous System Tumors
    • Solid tumors
      • ENCIT-01: Engineered Neuroblastoma Cellular Immunotherapy
      • STRIvE-01: Phase I Study of EGFR806 CAR T Cell Immunotherapy for Relapsed or Refractory Solid Tumors in Children and Young Adults

    We have nine active CAR T-cell clinical trials open at Seattle Children’s. Several of these trials are also available at other clinical sites – Children’s Hospital Los Angeles, UCSF Benioff Children’s Hospital Oakland and Children’s National Medical Center. To date, we have had more than 200 enrollments in our immunotherapy clinical trials.

    Over the last two years alone, we’ve developed and received FDA approval for seven clinical trial protocols. We plan to open several new immunotherapy clinical trials and add new clinical trial sites in the United States and Canada in 2019.

  • Since our manufacturing facility is wholly owned by Seattle Children’s Research Institute, we do not have to wait in line behind other organizations to manufacture our immunotherapy products. This means we can deliver treatments quickly to patients enrolled in clinical trials at Seattle Children’s and at our collaborating sites.

    Our CSL processes all trial-related correlative specimens required by the clinical trial protocols at Seattle Children’s and other participating clinical trial sites. The CSL team evaluates patient samples through our in-house laboratory on a daily basis and provides real-time data to clinical investigators and researchers in the TIC, creating an essential feedback loop to support trial development and the design of more effective therapies.

    In traditional drug development, it can take several years – even up to a decade – from conceptualization of a new drug to opening a clinical trial. At the IIH, we have all of the components of the “bench-to-bedside” translational process coordinated through one organization to accelerate this timeline.

  • Since launching our first CAR T-cell clinical trial for acute leukemia in 2012, we quickly transformed what we learned early on into additional trials. We have opened five more trials for leukemia, all building on each other and with the hope of even better success rates. Over the last few years, we have broadened our work to include CAR T-cell clinical trials for certain types of lymphomas, solid tumors and brain and spinal cord tumors.

How to Participate in an Immunotherapy Clinical Trial at Seattle Children’s

If you are looking for a clinical trial for your child, please work with your child’s provider to see if a trial is open for your child’s type of cancer. You can read about the cancer immunotherapy clinical programs at Seattle Children’s here:

How to Join Our Team

To learn more about working for us or to see if your skills match our current needs, visit our careers site.

How to Support Our Work 

If you are interested in supporting the advancement of immunotherapy and cancer research at Seattle Children’s, please visit our donation page.