Calibr-Skaggs receives FDA approval to test sCAR-T therapy in patients with autoimmune diseases

Calibr-Skaggs Institute for Innovative Medicines, the drug discovery division of Scripps Research, announced today that the FDA has cleared their investigational new drug (IND) application to study switchable chimeric antigen receptor T cell (sCAR-T) therapy (CLBR001 + SWI019) in patients with autoimmune conditions. Patient recruitment for the phase 1 trial will begin soon (NCT06913608). The phase 1 clinical trial will evaluate the safety and efficacy of CLBR001 + SWI019 in patients with myositis, systemic sclerosis, lupus and rheumatoid arthritis, with the potential to expand to other indications in the future. Calibr-Skaggs' novel sCAR-T therapy is designed to reduce side effects and patient burden associated with prior lymphodepletion treatments required for traditional CAR-T approaches-an important issue for rheumatologists and patients.

Autoimmune diseases are often chronic conditions that affect up to ~15 million people in the U.S. and up to 12% of the global population. CAR-T cell therapy has demonstrated curative potential in select autoimmune diseases by creating a system-wide immune 'reset', improving a patient's quality of life, and reducing the need for life-long immune suppressants. However, conventional CAR-T cell therapies require lymphodepletion – a chemotherapy procedure used to eliminate existing immune cells to ensure the CAR-T cells can effectively expand. Further, this procedure can lead to increased risk of infection and severe side effects. CLBR001 + SWI019 was designed to avoid these issues by eliminating the need for lymphodepletion, reducing side effects and potentially making treatment accessible to a broader patient population.

Patients with chronic autoimmune diseases need curative options that do not require life-long immunosuppressive therapy to manage their condition. Our CLBR001 + SWI019 cell therapy has the potential to transform the treatment paradigm for patients by eliminating chemotherapy-associated risks."

Travis Young, vice president of biologics, Calibr-Skaggs

Calibr-Skaggs' Chief Medical Officer Chan Beals says, "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."

Patient enrollment for the clinical trial is anticipated to begin soon. Interested participants or referring clinicians can find more information by visiting calibr.scripps.edu or clinicaltrials.gov (NCT06913608).