First patients dosed with Cabaletta CAR-T made on Cellares automated platform

Cabaletta Bio’s investigational CAR-T cell therapy, rese-cel, has been infused into the first two patients using drug product manufactured on Cellares' Cell Shuttle automated manufacturing platform.

"This milestone is a transformative moment for the field of autologous cell therapy," said Fabian Gerlinghaus, co-founder and CEO of Cellares. "For years, the promise of autologous CAR T has been constrained by manufacturing models that were never designed to scale. The successful dosing of patients with rese-cel manufactured on the Cell Shuttle demonstrates that automation can deliver GMP drug products on time and within specification.”

The Cell Shuttle's automated, end-to-end manufacturing workflow reduces manual touchpoints, minimizes variability, and enables standardized execution across runs, equipment, and facilities. When combined with Cellares’ Cell Q high-throughput quality control and release testing platform, the integrated solution is designed to meet the demands of scalable commercial production while maintaining the rigorous quality standards required for clinical and commercial-scale use.

The partnership with Cabaletta, first announced in 2023 as a Technology Adoption Program (TAP), utilizes Cellares’ automated cell therapy manufacturing platform for Cabaletta’s lead clinical candidate, a CD19-targeting CAR-T cell therapy for patients with autoimmune diseases. In March 2025, the companies announced that they had successfully delivered automated, concurrent manufacture of multiple batches of Cabaletta’s rese-cel on a single Cellares Cell Shuttle platform. The dataset generated over the three year partnership supported the submission and subsequent FDA clearance of an IND amendment to use the Cell Shuttle platform for clinical manufacturing of rese-cel.

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.