Calibr-Skaggs Institute for Innovative Medicines, the drug discovery division of Scripps Research, announced on Apr. 10 that the U.S. Food and Drug Administration has cleared its investigational new drug application to study switchable chimeric antigen receptor T cell (sCAR-T) therapy in patients with autoimmune conditions. The phase 1 clinical trial will soon begin recruiting patients under the identifier NCT06913608.
This development is significant as it could provide a new treatment option for individuals with chronic autoimmune diseases such as myositis, systemic sclerosis, lupus, and rheumatoid arthritis. These diseases affect millions in the United States and globally, often requiring life-long immune suppressants.
The upcoming trial will assess both safety and efficacy of Calibr-Skaggs' novel CLBR001 + SWI019 sCAR-T therapy. Unlike traditional CAR-T therapies that require lymphodepletion—a chemotherapy process that can increase infection risk and cause severe side effects—this approach is designed to avoid lymphodepletion altogether. This could reduce side effects and expand access to a broader patient population.
According to Chief Medical Officer Chan Beals, "Successfully establishing safety and efficacy of CLBR001 + SWI019 for conditions like lupus and rheumatoid arthritis could pave the way for broader therapeutic use in other autoimmune diseases, offering new hope to many more patients in the future."
The CLBR001 + SWI019 therapy uses two components: a sCAR-T cell (CLBR001) and a protein-based biologic "switch" (SWI019) targeting CD19-positive B cells. Previous studies have shown promising results treating B cell malignancies with this method by shortening adverse effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Preclinical work also demonstrated its effectiveness without lymphodepletion.
Patient enrollment is expected to begin soon, with further information available at calibr.scripps.edu or clinicaltrials.gov using identifier NCT06913608.
