Calibr-Skaggs to Initiate Clinical Trial of Switchable CAR-T Therapy for Autoimmune Diseases
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Calibr-Skaggs Biomedical, Inc. is preparing to launch a clinical trial evaluating the safety and efficacy of its innovative switchable CAR-T cell therapy, CLBR001 + SWI019, in patients with lupus and rheumatoid arthritis. This marks a significant step towards expanding the potential of CAR-T cell therapy beyond cancer treatment and into the realm of autoimmune diseases, offering a potential new treatment option for millions.Calibr announced the planned trial on November 28, 2023.
Understanding the Potential: CAR-T Therapy and Autoimmune Disease
Conventional CAR-T cell therapy has revolutionized cancer treatment by engineering a patient’s own immune cells to target and destroy cancer cells. However, its submission to autoimmune diseases – where the immune system mistakenly attacks the body’s own tissues – presents unique challenges.Autoimmune diseases require a more controlled immune response than the complete eradication of a target seen in cancer therapy.
Calibr-Skaggs’ approach aims to address this with a “switchable” CAR-T system, allowing for precise control over immune cell activity. Prosperous trials could open doors to treating a wide range of autoimmune conditions.
How CLBR001 + SWI019 Works: A Two-Part System
CLBR001 + SWI019 differs from traditional CAR-T therapies by utilizing two key components:
CLBR001 (sCAR-T cell): This is a CAR-T cell engineered to express a synthetic receptor. This receptor doesn’t activate the T cell on its own. SWI019 (the “switch”): This is a protein-based biologic that specifically targets CD19-positive B cells.When SWI019 binds to both the CAR-T cell and the target B cell, it activates the CAR-T cell to eliminate the B cell.
This two-part system offers several potential advantages:
Controlled Activation: The “switch” allows doctors to control when and how strongly the CAR-T cells are activated, minimizing off-target effects. Reduced Toxicity: Early trials in B cell malignancies have shown the therapy can shorten the duration of common CAR-T related side effects like Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Calibr
Lymphodepletion-Free Potential: Preclinical data suggests CLBR001 + SWI019 may work effectively without the need for lymphodepletion – a common, and often harsh, pre-conditioning step in traditional CAR-T therapy.Lymphodepletion weakens the patient’s existing immune system to make room for the engineered CAR-T cells.
Robust Persistence: In early-stage trials, CLBR001 cells expanded and persisted in patients’ blood at higher levels compared to currently approved CAR-T products.
Clinical Trial Focus: Lupus and Rheumatoid Arthritis
The upcoming clinical trial will focus on patients with lupus and rheumatoid arthritis, both chronic autoimmune diseases affecting millions worldwide.
Lupus: A systemic autoimmune disease that can affect many different organs, including the skin, joints, kidneys, brain, and blood cells. National Institute of Arthritis and Musculoskeletal and Skin Diseases
Rheumatoid Arthritis: A chronic inflammatory disorder primarily affecting the joints, causing pain, swelling, and stiffness. Arthritis Foundation
By targeting CD19-positive B cells, which play a role in the pathogenesis of both diseases, CLBR001 + SWI019 aims to modulate the immune response and alleviate symptoms.
Key Takeaways
Calibr-Skaggs is initiating a clinical trial of its switchable CAR-T therapy (CLBR001 + SWI019) for lupus and rheumatoid arthritis.
This therapy utilizes a unique two-component system for controlled CAR-T cell activation.
* CLBR001 + SWI019 has shown promising results in B cell malignancies, with reduced toxicity and robust cell persistence.
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