Early Data from Cabaletta Bio Indicates CAR-T Potential in Inflammatory Diseases

In recent developments within the CAR-T therapy landscape, a shift from cancer treatment to addressing inflammatory diseases is gaining momentum. Emerging clinical data now provide insights into this new focus. On Friday, Cabaletta Bio shared the first results from its anti-CD19 CAR-T therapy, CABA-201, which is being tested for efficacy in treating lupus and myositis. The findings, which were presented at the European Congress of Rheumatology (EULAR) annual meeting, indicate promising clinical benefits and a well-tolerated safety profile.

Cabaletta Bio is currently investigating CABA-201 through two Phase I/II clinical trials: the RESET-SLE study for systemic lupus erythematosus and the RESET-Myositis trial for patients suffering from muscle-weakening autoimmune conditions. As of May 28, a single patient from each study had received an infusion of CABA-201 at a dosage of 1 x 10^6 cells per kilogram. Follow-up data include one month for the lupus patient and three months for the myositis patient.

The results have shown significant progress in both cases. Both patients experienced complete B-cell depletion within 15 days after the infusion of CABA-201. This observation was accompanied by improvements in disease-specific measures. For the patient in the myositis study, who is addressing immune-mediated necrotizing myopathy (IMNM), B-cell repopulation was observed by the eighth week post-infusion. Cabaletta Bio interprets this as a sign of a potential "immune system reset."

Safety data from the preliminary results are also encouraging. There were no signs of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in either patient. Additionally, both patients were able to discontinue their chronic maintenance therapies or concomitant medications, except for a planned prednisone taper for the lupus patient.

Cabaletta Bio's Chief Medical Officer, David Chang, remarked that these early data provide critical validation for the selected dosage of CABA-201 in resetting the immune system. This therapy is also under investigation in other Phase I/II trials targeting systemic sclerosis and generalized myasthenia gravis, with preliminary data expected later this year.

The initial success of CABA-201 in treating lupus and myositis marks a significant step forward in the application of CAR-T therapies beyond oncology. The strategy of resetting the immune system to treat autoimmune conditions opens new avenues for therapeutic development, potentially benefiting a broader range of patients suffering from various inflammatory diseases. As more data emerges, the medical community will better understand the full scope and efficacy of CAR-T therapies in these new indications.