Immunotherapy Coordinating Center
Seattle Children’s Immunotherapy Coordinating Center (ICC) – part of the Immunotherapy Integration Hub – conducts all of the functions necessary to guide the immunotherapy treatments created in our laboratories from the pre-clinical stage to the bedside. Having an in-house coordinating center ensures a more seamless and efficient process as we aim to deliver cures to more children and young adults with cancer.
The ICC has three main functions:
The ICC team moves the immunotherapy treatments developed by the Therapeutics Innovation Core (TIC) through the regulatory process. The ICC submits the necessary information and the investigational new drug (IND) applications to the U.S. Food and Drug Administration (FDA) and other regulatory bodies.
The Clinical Trial Management (CTM) group within the ICC writes the protocol (the document that instructs clinical trial sites on how to conduct the study) and ensures each site understands the study requirements and how to collect and record information on their patients’ experiences during treatment with chimeric antigen receptor (CAR) T-cell products.
The CTM group regularly checks with the clinical trial sites to answer questions and makes sure they are following the protocol and that the data they collect meets ethical and regulatory standards.
The ICC includes a Biostatistics and Data Management team that manages clinical data, runs necessary reports for our Data Monitoring Committees and the FDA, analyzes data for presentation and publication, and maintains all necessary data systems.
Current Immunotherapy Clinical Trials
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.
BrainChild-01 and BrainChild-02 are immunotherapy clinical trials for children and young adults with recurrent or refractory brain and spinal cord (central nervous system) tumors who are not likely to survive with standard treatments.
We offer immunotherapy clinical trials for children and young adults with solid tumors.
Our Engineered Neuroblastoma Cellular Immunotherapy (ENCIT-01) clinical trial tests T-cell therapy in children and young adults with recurrent or refractory neuroblastoma.
Our STRIvE-01 clinical trial reprograms a patient’s T cells to recognize and target the protein EGFR, which is expressed by many childhood solid tumors, including sarcomas, kidney tumors and neuroblastoma.
Upcoming Immunotherapy Clinical Trials
We plan to open two new immunotherapy clinical trials and add new clinical trial sites in the United States and Canada in 2019.
- Julie Park, MD, medical director
- Rebecca Gardner, MD, associate medical director and leukemia and lymphoma program lead
- Navin Pinto, MD, solid tumor program lead
- Nicholas Vitanza, MD, brain tumor program lead
- Cristin Gordon-Maclean, director of the ICC
- Leslie Elliott, manager of clinical trial management
- Zahid Hossain, supervisor of regulatory affairs
- Vivy Buntaran, supervisor of clinical data management
- Tracie Van Etten, manager of quality assurance