CAR T-Cell Immunotherapy Clinical Trials for Solid Tumors

Seattle Children’s doctors and researchers are leaders in developing investigational chimeric antigen receptor (CAR) T-cell immunotherapies for children and young adults with relapsed or refractory solid tumors.

T-cell immunotherapy is an experimental cancer treatment that stimulates the immune system to fight disease.

Read more about how T-cell immunotherapy for solid tumors works.

Food and Drug Administration-authorized trials at Seattle Children’s are testing T-cell therapy in children and young adults with relapsed or refractory solid tumors who are not likely to survive with current treatments.

These phase 1 trials, developed by Seattle Children's Therapeutics, are known as STRIvE and ENLIGHTen.

How is CAR T-cell therapy used for patients with solid tumors?

Seattle Children’s is testing CAR T-cell therapy in children and young adults with relapsed or refractory solid tumors who are not likely to survive with standard treatments.

In the STRIvE-01 trial, the patient’s own T cells are reprogrammed to recognize and target the protein EGFR, which is expressed by many childhood solid tumors, including sarcomas, kidney tumors and neuroblastoma. 

The study began in August 2018 and is currently enrolling patients. 

• Read more about the STRIvE-01 protocol at clinicaltrials.gov.
• Learn more about this and other clinical trials at Seattle Children’s.
• For more information, call 206-987-2106 or send us an email.

What is the goal of this solid tumor CAR T-cell study? 

STRIvE-01 is a phase 1 clinical trial. Phase 1 trials focus on finding out how much of a therapy to give, how to give it, how often to give it and when side effects occur. Through the STRIvE studies, researchers are working to answer these questions:

• Is T-cell therapy safe to give to children, teens and young adults with relapsed or refractory solid tumors?
• What is the best dose of CAR T cells for children, teens and young adults with solid tumors?
• Does T-cell therapy work against solid tumors? 

Who can join this solid tumor CAR T-cell study? 

The STRIvE-01 study is for children, teens and young adults who:

• Have relapsed or refractory solid tumors
• Have a tumor that expresses EGFR
• Are ages 1 to 30 years old 

Researchers use many other factors to decide whether a patient can take part in a study (inclusion criteria) or cannot take part (exclusion criteria). The study team at Seattle Children’s can explain what these factors mean for you or your child.

Who is leading this solid tumor T-cell clinical trial? 

Dr. Catherine (Katie) Albert is leading the STRIvE-01 clinical trial. Albert is a doctor in the Cancer and Blood Disorders Center at Seattle Children’s Hospital and an investigator in the Ben Towne Center for Childhood Cancer and Blood Disorders Research at Seattle Children’s Research Institute.

T-cell trials at Seattle Children’s use methods developed by Seattle Children's Therapeutics at Seattle Children’s Research Division. 

Are there CAR T-cell clinical trials for other childhood cancers?

STRIvE-01 is one of our many T-cell immunotherapy trials focused on using the immune system to offer better treatment options for children, teens and young adults with cancers, including: 

• Leukemia and lymphoma (PLAT)
• Brain and central nervous system tumors (BrainChild)
• Osteosarcoma (ENLIGHTen-01)

Contact Us

For more information, call 206-987-2106 or send us an email. 

Learn More 

• Learn more about our Bone Tumor and Sarcoma Clinic.
• Find other cancer clinical trials at Seattle Children’s:
  • On our Research Studies page.
  • On ClinicalTrials.gov. Read our guide about searching for trials on ClinicalTrials.gov (PDF).
• Learn about Seattle Children's Therapeutics. 

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

Updated July 2023.