Cabaletta Bio’s early data signal potential of CAR-T in inflammatory diseases
14 Jun 2024
Clinical ResultCell TherapyImmunotherapyClinical Study
With a growing number of CAR-T developers having recently shifted focus from cancer to inflammatory diseases, the first early clinical data are starting to emerge.
On Friday, Cabaletta Bio reported results from the first two patients treated with its anti-CD19 CAR-T therapy CABA-201 for lupus and myositis, demonstrating what the company called an “emerging clinical benefit” and well-tolerated safety profile. Findings were presented at the European Congress of Rheumatology (EULAR) annual meeting.
Cabaletta is investigating CABA-201 in the Phase I/II RESET-SLE study for systemic lupus erythematosus and the Phase I/II RESET-Myositis trial of patients with the muscle-weakening autoimmune disease. The drugmaker noted that as of May 28, one patient has been treated in each study with a single infusion of CABA-201 at 1 x 106 cells/kg, with one month of follow-up in the lupus trial and three months of follow-up in the myositis study.
Immune system reset
According to Cabaletta, complete B-cell depletion was observed within 15 days post-infusion with CABA-201 in both patients, who also demonstrated improvements in specific disease measures. In the myositis study, B-cell repopulation was observed at week 8 in the participant – who is being treated for immune-mediated necrotising myopathy (IMNM) – which the company said suggests a “potential immune system reset.”
Cabaletta added that no evidence of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was seen in either patient. Meanwhile, both participants discontinued all chronic maintenance therapy or concomitant medications, other than a planned prednisone taper for the lupus patient.
David Chang, chief medical officer of Cabaletta, suggested that the data “provide important early validation” of the selected CABA-201 dose to reset the immune system. The therapy is also being studied in Phase I/II trials for systemic sclerosis and generalised myasthenia gravis, with initial data expected in the second half.
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