

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.
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.
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