The Food and Drug Administration (FDA) has granted clearance for the investigational new drug (IND) application of Calibr-Skaggs Institute for Innovative Medicines, US, for a Phase I trial of switchable chimeric antigen receptor T cell (sCAR-T) therapy CLBR001 + SWI019 in subjects with autoimmune conditions.
Calibr-Skaggs Institute for Innovative Medicines is Scripps Research’s drug discovery division.
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Subject recruitment for the trial is set to commence shortly, aiming to assess the efficacy and safety of the therapy in treating rheumatoid arthritis, systemic sclerosis, lupus, and myositis, with a possibility of extending to additional indications in the future.
This sCAR-T therapy is tailored to alleviate the side effects and the individual’s burden related to previous lymphodepletion treatments, which are necessary for the traditional CAR-T approach.
According to the institute, CAR-T cell therapy has shown potential in providing a system-wide immune “reset” in certain autoimmune conditions, enhancing the quality of life for individuals and decreasing the dependency on “lifelong” immune suppressants.
Yet, traditional therapies necessitate lymphodepletion, a chemotherapy process to remove current immune cells, which can result in a heightened infection risk and severe side effects, noted the institute.
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By GlobalDataThis sCAR-T cell therapy has been engineered to circumvent these challenges by obviating the lymphodepletion need, thus diminishing side effects.
Calibr-Skaggs’ approach claims to vary from the conventional ones by utilising a two-component system: a sCAR-T cell, CLBR001, and SWI019, a protein-based biologic “switch” that specifically aims at B cells which are cluster of differentiation 19 (CD19)-positive.
Calibr-Skaggs Institute for Innovative Medicines biologics vice-president Travis Young said: “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.”
Calibr-Skaggs Institute, utilising Scripps Research’s scientific framework, has developed a portfolio of drug candidates leveraging Scripps’ technologies.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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