The Caliber Skaggs Institute for Innovative Medicines, a drug discovery arm of Scripps Research, today announced that the FDA has approved its investigational new drug (IND) application to study switchable chimeric antigen receptor T-cell (sCAR-T) therapy (CLBR001 + SWI019) in patients with autoimmune diseases. Patient recruitment for the Phase 1 trial will begin soon (NCT06913608). A Phase 1 clinical trial will evaluate the safety and efficacy of CLBR001 + SWI019 in patients with myositis, systemic sclerosis, lupus, and rheumatoid arthritis, with potential expansion to other indications in the future. Calibr-Skaggs’ new sCAR-T therapy is designed to reduce the side effects and patient burden associated with upfront lymphodepletion treatments required with traditional CAR-T approaches, an important issue for rheumatologists and patients.
Autoimmune diseases are often chronic conditions, affecting up to 15 million people in the United States and up to 12% of the world’s population. CAR-T cell therapy has demonstrated curative potential in some autoimmune diseases by causing a system-wide immune ‘reset’, improving patients’ quality of life and reducing the need for lifelong immunosuppressive drugs. However, traditional CAR-T cell therapy requires lymphodepletion, a chemotherapy procedure used to remove existing immune cells so that CAR-T cells can effectively proliferate. Additionally, this procedure can increase the risk of infection and cause serious side effects. CLBR001 + SWI019 was designed to avoid these issues by eliminating the need for lymphodepletion, reducing side effects, and making the treatment accessible to a broader patient population.
Patients with chronic autoimmune diseases need treatments that do not require lifelong immunosuppressive therapy to manage their condition. Our CLBR001 + SWI019 cell therapy has the potential to transform the treatment paradigm for patients by eliminating the risks associated with chemotherapy. ”
Travis Young, Vice President, Biologics, Caliber Skaggs
“Success in establishing the safety and efficacy of CLBR001 + SWI019 for diseases such as lupus and rheumatoid arthritis could pave the way for broader therapeutic use in other autoimmune diseases, potentially bringing new hope to more patients in the future,” said Chan Beers, chief medical officer at Calibr-Skaggs.
Patient enrollment for the clinical trial is expected to begin soon. Interested participants or referring clinicians can find more information by visiting calibr.scripps.edu or clinicaltrials.gov (NCT06913608).
About CLBR001 + SWI019 switchable CAR-T
Calibr-Skaggs’ CLBR001 + SWI019 switchable CAR-T cell therapy differs from traditional CAR-T approaches by leveraging two components: sCAR-T cells (CLBR001) and a protein-based biological “switch” that targets CD19+ B cells (SWI019). CLBR001 + SWI019 has already demonstrated promising results in the treatment of patients with B-cell malignancies, with the ability to reduce the duration of side effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and preclinical studies have demonstrated a unique ability to exert efficacy without lymphocyte depletion. In early-stage trials, CLBR001 cells proliferated to higher levels and demonstrated strong persistence in patients’ peripheral blood compared to approved CAR-T cell products.
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Scripps Research Institute
