April 09, 2025

FDA clears IND for clinical trial testing switchable CAR-T therapy in patients with autoimmune diseases, without chemotherapy Innovative cellular therapy has potential to treat patients with lupus, systemic sclerosis, myositis and RA without chemotherapy-induced immune suppression.

April 09, 2025

LA JOLLA, CA 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, says Travis Young, vice president of biologics at Calibr-Skaggs. Our CLBR001 SWI019 cell therapy has the potential to transform the treatment paradigm for patients by eliminating chemotherapy-associated risks.

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).

About CLBR001 SWI019 Switchable CAR-T

Calibr-Skaggs' CLBR001 SWI019 switchable CAR-T cell therapy differs from conventional CAR-T approaches by leveraging two components, a sCAR-T cell (CLBR001) and a protein-based biologic switch (SWI019) that targets CD19-positive B cells. CLBR001 SWI019 has already demonstrated promising results in treating patients with B cell malignancies, with the ability to shorten the duration of adverse effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and preclinical work has demonstrated the unique ability to work without lymphodepletion. In early-stage trials, CLBR001 cells expanded in patients to higher levels in peripheral blood compared to approved CAR-T cell products, with robust persistence.

About Scripps Research

Scripps Research is an independent, nonprofit biomedical research institute ranked one of the most influential in the world for its impact on innovation by Nature Index. We are advancing human health through profound discoveries that address pressing medical concerns around the globe. Our drug discovery and development division, Calibr-Skaggs, works hand-in-hand with scientists across disciplines to bring new medicines to patients as quickly and efficiently as possible, while teams at Scripps Research Translational Institute harness genomics, digital medicine and cutting-edge informatics to understand individual health and render more effective healthcare. Scripps Research also trains the next generation of leading scientists at our Skaggs Graduate School, consistently named among the top 10 U.S. programs for chemistry and biological sciences. Learn more at www.scripps.edu.

About the Calibr-Skaggs Institute for Innovative Medicines

The Calibr-Skaggs Institute for Innovative Medicines was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Leveraging the unique scientific framework of Scripps Research, Calibr-Skaggs has created a portfolio of drug candidates based on Scripps Research technologies and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients. Learn more at calibr.scripps.edu.

Calibr-Skaggs

LINK:	https://www.scripps.edu/news-and-events/press-room/2025/20250408-calib...
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