Our RESETTM clinical trials with rese-cel (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris are now recruiting.
What if autoimmune diseases could be cured with a one-time treatment? At Cabaletta Bio, we believe it is possible.
On a proven foundation of CAR T technology and an established track record of clinical operational excellence in cell therapy in autoimmunity since 2018, we are developing innovative engineered T cell therapies for patients with autoimmune diseases. Our proprietary Cabaletta Approach to B cell Ablation (CABA®) platform is designed to provide deep, durable, and potentially curative responses with one-time administration across many autoimmune diseases, and it encompasses two approaches.
The Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach is designed to transiently, but fully, eliminate B cells, thus potentially enabling an “immune system reset.” Our lead CARTA candidate, rese-cel (resecabtagene autoleucel, formerly CABA-201), is a fully human CD19-CAR T cell product candidate being evaluated in the RESETTM Phase 1/2 trials in autoimmune diseases with high unmet need, including in systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis and pemphigus vulgaris.
To harness the immune system through innovative cell and gene therapies to deliver accessible cures for patients.
Since Cabaletta Bio was founded and emerged from the University of Pennsylvania in 2017, we have been working toward a singular goal: Developing and launching the first curative targeted cellular therapies for patients with autoimmune diseases.
Since then, we have been focused on advancing clinical studies of novel cell therapy programs in autoimmune disease. Our initial scientific platform has yielded two clinical-stage programs in pemphigus vulgaris and MuSK myasthenia gravis, honing our capabilities to implement studies requiring collaboration between autoimmune treating physicians and cell therapy specialists. As we advanced these elegant product candidates, we were excited to see emerging data that suggested the potential of CD19-CAR T cell therapy approaches to reset the immune system in patients with autoimmune disease. Informed by our expertise in autoimmunity, we conducted a global search to identify the optimally designed product candidate for patients with autoimmune diseases to potentially replicate the promising efficacy and safety observed in these academic reports. This led us to develop rese-cel, a fully human CD19-CAR T with a 4-1BB co-stimulatory domain, which is ideally suited for application in autoimmune disease.
Since announcing rese-cel, we have had six INDs cleared for Phase 1/2 clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis, and generalized myasthenia gravis, pemphigus vulgaris and multiple sclerosis. As we aim to advance our rapid and broad development program with rese-cel, our progress is accelerated by our team’s deep expertise in cell therapy, robust clinical experience in autoimmunity, and demonstrated track record of strong execution. We remain focused on furthering our mission to develop therapies that deliver deep, durable and potentially curative responses for patients with autoimmune diseases.
Cabaletta Bio was founded by leading experts in autoimmune diseases and CAR T technology. Today, we are led by a team of physicians, scientists, and pharmaceutical industry veterans broadly experienced in developing and manufacturing novel cell therapies and bringing them to market.
