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Seattle Children's Initiates First U.S. CAR T-Cell Trial for Pediatric Lupus

• Seattle Children's has begun enrolling participants in the first U.S. clinical trial of CAR T-cell therapy for pediatric systemic lupus erythematosus (SLE). • The Phase 1 trial, REACT-01, aims to enroll 12 participants aged 2 to 30 with treatment-resistant lupus, initially focusing on those 17 and older. • CAR T-cell therapy involves genetically altering cells to reset the immune system by targeting B cells, which produce autoantibodies in lupus. • The study offers a potential new treatment avenue for children with SLE who have not responded to conventional therapies.

Seattle Children's has announced the enrollment of participants in the first U.S. clinical trial evaluating CAR T-cell therapy for children with systemic lupus erythematosus (SLE). This Phase 1 trial, known as Reversing Autoimmunity through Cell Therapy (REACT-01), marks a significant step forward in exploring novel treatments for pediatric lupus.
The REACT-01 trial plans to enroll 12 participants between the ages of 2 and 30 who have lupus that is resistant to current treatment regimens. The initial focus will be on participants aged 17 and older. CAR T-cell therapy involves genetically modifying a patient's own T cells to target and eliminate B cells, which are implicated in the production of autoantibodies that drive lupus disease activity.

CAR T-Cell Therapy Mechanism

CAR T-cells are engineered to express a receptor that specifically recognizes a protein on the surface of B cells. Once infused back into the patient, these modified T cells seek out and destroy B cells, aiming to reset the immune system and reduce autoimmune activity. This approach has shown promise in treating certain types of cancer, and researchers are now investigating its potential in autoimmune diseases like lupus.

Significance for Pediatric Lupus

Systemic lupus erythematosus is a chronic autoimmune disease that can affect multiple organ systems. Current treatments often involve immunosuppressive drugs, which can have significant side effects. For children with lupus that is resistant to these treatments, the REACT-01 trial offers a potential new avenue for disease management. The trial's focus on CAR T-cell therapy represents a targeted approach to modulate the immune system and potentially induce long-term remission.

Study Design and Endpoints

The Phase 1 trial will primarily assess the safety and feasibility of CAR T-cell therapy in pediatric lupus patients. Researchers will also monitor for changes in disease activity and immune function. The study will provide valuable data on the potential benefits and risks of this innovative treatment approach in this vulnerable population.
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Reference News

[1]
Seattle Children's Now Enrolling Participants for First U.S. CAR T Cell Clinical Trial for ...
lupus.org · Nov 12, 2024

Seattle Children’s announced enrollment in the first CAR T cell clinical trial for children with systemic lupus erythema...

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