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# FDA OKs CAR-T Trial in Children for Lupus
- URL: https://www.fdaweb.com/fda-oks-car-t-trial-in-children-for-lupus/
- Published: 2024-04-10T12:00:00.000Z
- Updated: 2026-09-14T14:28:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156746

FDA has authorized Seattle Children’s to launch the first chimeric antigen receptor (CAR) T-cell clinical trial in the U.S. for children under age 18 with the most common form of lupus. “Despite recent advances in lupus management, many patients have lupus that is resistant to current treatment regimens,” a Seattle Children’s [statement](https://pulse.seattlechildrens.org/seattle-childrens-set-to-launch-first-us-car-t-cell-clinical-trial-for-children-with-lupus/?ref=fdaweb.com) says. “Even among treatment-responsive subjects, available medications need to be taken chronically with little or no expectation of durable remission off therapy.”

The statement says the Reversing Autoimmunity through Cell Therapy (REACT-01) study will be 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.