Cabaletta continues to build a case for CAR-T therapy in autoimmune disease

Cabaletta Bio announced positive clinical data and development updates across a trio of trials evaluating rese-cel, an autologous CAR-T cell therapy, in patients with various autoimmune diseases.

Updates on the RESET-Myositis, RESET-SSc and RESET-SLE trials will be presented in multiple oral and poster presentations at the ongoing American College of Rheumatology (ACR) Convergence 2025.

“The clinical data to be presented at ACR reinforce the potential of a single weight-based dose of rese-cel to deliver durable, drug-free clinical responses across multiple autoimmune diseases. The consistency of responses through the primary endpoint of the registrational cohort in patients meeting the key inclusion criteria is particularly encouraging. We look forward to initiating the myositis registrational trial and anticipate alignment with FDA on the designs for lupus and systemic sclerosis this year,” said David J. Chang, MD, Cabaletta’s chief medical officer.

Cabaletta recently presented initial dose data from the phase 1/2 RESET-PV trial evaluating rese-cel without preconditioning in three evaluable patients with pemphigus vulgaris, a rare autoimmune disease that causes painful blisters on the body. In the trial, all three patients experienced substantial depletion of B cells within the first month post-infusion, with patients 2 and 3 achieving complete peripheral B cell depletion.

Rese-cel is a 4-1BB-containing fully human CD19-CAR-T cell therapy for patients with autoimmune diseases where B cells contribute to the initiation and/or maintenance of disease. Following a one-time infusion of a weight-based dose, rese-cel is designed to transiently and deeply deplete all CD19-positive cells in both the peripheral circulation and within tissues. This approach has the potential to reset the immune system and result in profound clinical responses without chronic therapy requirements in patients.