FDA authorizes first CAR T-cell trial for children with lupus
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Key takeaways:
- Reversing Autoimmunity through Cell Therapy (REACT-01) is expected to launch this summer.
- The trial will be led out of Seattle Children’s Therapeutics, which works on next-gen pediatric therapies.
The FDA has authorized the first chimeric antigen receptor T-cell clinical trial for children with systemic lupus erythematosus.
The trial, called Reversing Autoimmunity through Cell Therapy (REACT-01), will be led out of Seattle Children’s and is expected to launch this summer, according to a blog post from the hospital.
“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,” Shaun W. Jackson, MD, PhD, the study’s principal investigator, said in the post.
The trial comes as CAR T-cell investigations are burgeoning across a range of autoimmune diseases and are seen as marking a potential new era in treatment. Earlier this year, data in The New England Journal of Medicine demonstrated single injections of CD19 CAR T cells bringing long-lasting remission to 15 patients with three different autoimmune diseases.
The REACT-01 trial will be administered by Seattle Children’s Therapeutics, a “novel nonprofit therapeutics development enterprise” focused on new gene and cell therapies for pediatric diseases, according to the blog post.
“Seattle Children’s is excited to launch this first-in-the-country trial that has the potential to offer life-changing relief for patients,” Vittorio Gallo, PhD, senior vice president and chief scientific officer at Seattle Children’s, said in the post. “We are committed to utilizing research to pioneer breakthrough therapies and provide access to cutting-edge clinical trials in pediatric health care.”
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