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Promising CAR T Cell Therapies from BMS and Cabaletta Bio Show Potential for Durable Remission in Severe Lupus

NextEdge Admin

14 Nov 2024

2 min 42 sec

Cabaletta Bio,CAR T therapies,Cell & Gene Therapies,Rheumatology

Bristol Myers Squibb (BMS) and Cabaletta Bio are set to present promising Phase I data on CD19-directed CAR T therapies for severe, refractory lupus at the 2024 American College of Rheumatology conference. BMS's investigational CAR T therapy, CC-97540 (BMS-986353), produced using the advanced NEX-T manufacturing process, and Cabaletta Bio's fully human CABA-201, both demonstrated significant efficacy in treating severe, refractory lupus.

In Phase I results, CC-97540 showed strong efficacy in patients with challenging lupus cases, including renal involvement, with all patients achieving substantial improvements in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Physician Global Assessment (PGA), and Health Assessment Questionnaire Disability Index (HAQ-DI) scores. Importantly, this was achieved with sustained B cell depletion and without severe side effects. Similarly, CABA-201 resulted in rapid B cell depletion and a 16-point improvement in SLEDAI-2K scores, all without requiring ongoing immunosuppressive therapy.

These findings underscore CAR T therapy’s potential to offer lasting, drug-free remission for lupus and other autoimmune diseases. Simi Badyal, MSc, Senior Competitive Intelligence Immunology Analyst at GlobalData, notes that these advancements could herald a "paradigm shift," moving towards single-infusion CAR T therapies that recalibrate the immune system, a transformative approach for lupus patients with limited therapeutic options.

As highlighted in GlobalData’s *Cell & Gene Therapies in Rheumatology* report, lupus and osteoarthritis are leading the cell and gene therapy pipeline in rheumatology, reflecting a high unmet need in conditions like systemic lupus erythematosus (SLE) and lupus nephritis (LN). Early CAR T successes from BMS and Cabaletta Bio represent groundbreaking progress, with the potential to redefine lupus treatment and offer durable remission, a long-sought goal in managing severe autoimmune diseases.