Cabaletta Bio reported that the first two patients received the investigational CD19‑CAR T therapy, rese‑cel, on April 14 2026. The product was manufactured on Cellares’ automated Cell Shuttle platform, marking the first clinical use of the company’s automated manufacturing process.
The infusion represents a key milestone in Cabaletta’s strategy to scale production for thousands of patients annually. By moving from manual to automated manufacturing, the company aims to reduce costs, accelerate availability, and potentially enable outpatient, pre‑conditioning‑free dosing in future trials for autoimmune indications.
The partnership with Cellares began in 2023, and the FDA cleared an IND amendment in January 2026 to use the Cell Shuttle platform for clinical manufacturing. This regulatory approval signals confidence that the platform can deliver reliable GMP drug products at scale for the larger patient populations typical of autoimmune diseases.
Steven Nichtberger, M.D., Co‑founder, Chairman, and CEO of Cabaletta Bio, said, "This is an important milestone that reflects focused collaboration between the teams at Cabaletta and Cellares since 2023." He added, "The dosing of these first two patients is an important demonstration of Cellares' GMP manufacturing and supply chain capabilities with their automated manufacturing platform and thus represents a significant achievement towards our goal of securing high‑capacity flexible supply with minimal capital investment and a low cost of goods."
Fabian Gerlinghaus, Co‑founder and CEO of Cellares, commented, "Autoimmune cell therapy programs operate at a fundamentally different scale of patient demand than oncology. Achieving scalability in these larger indications is a differentiated feature of the Cellares platform. FDA approval of Cabaletta's IND Amendment reflects regulatory confidence in the Cell Shuttle platform to deliver reliable GMP drug products at scale."
The successful infusion demonstrates that the automated platform can produce product that meets all release criteria and is suitable for clinical use. It also provides early safety and efficacy data that will inform the ongoing RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. The milestone supports Cabaletta’s goal of expanding the platform across its pipeline, potentially enabling more efficient, cost‑effective manufacturing for a broad range of autoimmune indications.
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