First U.S. CAR T-cell Clinical Trial for Children with Lupus Now Enrolling Patients at Seattle Children’s

Seattle Children’s is now enrolling patients in the first chimeric antigen receptor (CAR) T-cell clinical trial in the U.S. for children with systemic lupus erythematosus.

Systemic lupus erythematosus is a chronic autoimmune disorder that affects multiple organ systems, resulting in significant morbidity and mortality. Approximately 20% of lupus patients have disease onset during childhood, and children with lupus are at particular risk for severe disease and worse long-term outcomes. For reasons that are not well understood, the incidence and severity of lupus is also increased in historically disadvantaged patient populations in the U.S., including Black and Latino communities.

Despite recent advances in lupus management, many patients have lupus that is resistant to current treatment regimens. Even among treatment-responsive subjects, available medications need to be taken chronically with little expectation of durable remission off therapy.

The phase 1 trial, known as the Reversing Autoimmunity through Cell Therapy, or REACT-01 study, is led and administered by Seattle Children’s Therapeutics, a novel non-profit therapeutics development enterprise, devoted to envisioning and testing next-generation cell and gene therapies for pediatric diseases so children have the medicines they deserve.

“Our hope is that this therapy holds the potential to put patients with systemic lupus erythematosus into true remission without the need for ongoing medications,” said Dr. Shaun Jackson, principal investigator for the study.

The study plans to enroll 12 participants ages 2 to 30, and the first three patients to enroll must be age 17 or older. If you have a patient you’d like to refer to the trial, please contact shaun.jackson@seattlechildrens.org.