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The Calibr-Skaggs Institute for Innovative Medicines, a branch of Scripps Research focused on drug innovation, has received clearance from the FDA for its investigational new drug (IND) application. This approval will allow for the exploration of switchable chimeric antigen receptor T cell (sCAR-T) therapy, specifically CLBR001 in combination with SWI019, in patients suffering from various autoimmune diseases. Recruitment for the upcoming phase 1 clinical trial, registered as NCT06913608, is expected to commence shortly. This study will assess the safety and effectiveness of the therapy in individuals diagnosed with myositis, systemic sclerosis, lupus, and rheumatoid arthritis, with possible future applications for other autoimmune disorders.
Autoimmune diseases are prevalent chronic conditions, impacting approximately 15 million individuals in the United States and around 12% of the global population. CAR-T cell therapies have shown promise in potentially curing certain autoimmune disorders by enabling a comprehensive reset of the immune system, thus improving patients’ quality of life while decreasing their reliance on long-term immunosuppressive medications. However, traditional CAR-T therapies necessitate lymphodepletion, a chemotherapy regimen aimed at depleting existing immune cells to promote the effective expansion of CAR-T cells. This process can expose patients to heightened infection risks and significant side effects. The innovative CLBR001 + SWI019 therapy aims to circumvent these challenges by removing the need for lymphodepletion, thereby minimizing side effects and potentially broadening accessibility for a wider array of patients.
Travis Young, vice president of biologics at Calibr-Skaggs, stated, “Patients with chronic autoimmune diseases require curative therapies that do not entail lifelong immunosuppressive regimens to control their conditions. Our CLBR001 + SWI019 cell therapy holds the potential to shift the treatment landscape by removing the risks associated with chemotherapy.”
Chan Beals, the Chief Medical Officer of Calibr-Skaggs, commented, “Demonstrating the safety and efficacy of CLBR001 + SWI019 for conditions such as lupus and rheumatoid arthritis could lead to broader therapeutic applications in a variety of autoimmune diseases, offering renewed hope to many patients in the future.”
Enrollment for the clinical trial is expected to start in the near future.
About CLBR001 + SWI019 Switchable CAR-T
The CLBR001 + SWI019 switchable CAR-T cell therapy from Calibr-Skaggs distinguishes itself from traditional CAR-T treatments by employing two components: the sCAR-T cell (CLBR001) and a biologic “switch” (SWI019) that targets CD19-positive B cells. This innovative therapy has already shown encouraging results in managing B cell malignancies, particularly in mitigating adverse effects like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Preclinical studies indicate its unique capability to function without lymphodepletion. In initial trials, CLBR001 cells demonstrated a capacity for greater expansion and persistence in patients compared to standard CAR-T products.
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