Cellares has secured FDA clearance of an IND amendment allowing Cabaletta Bio to manufacture and release its investigational CAR T cell therapy rese-cel using Cellares’ automated manufacturing and quality control platforms, marking the first clinical use of the company’s technology.

The clearance covers the use of Cellares’ Cell Shuttle manufacturing system alongside its Cell Q quality control platform for the clinical production and release of rese-cel, also known as resecabtagene autoleucel. The therapy is being developed by Cabaletta for autoimmune diseases and is currently being evaluated in the company’s Reset clinical trial programme.

According to Cellares, the amended IND enables fully automated, end-to-end GMP manufacturing and high-throughput release testing of rese-cel for clinical use, with the first patient dosing expected in the first half of 2026. The programme represents the first time the Cell Shuttle and Cell Q platforms have been cleared to support an active clinical trial.

Fabian Gerlinghaus, co-founder and chief executive officer of Cellares, said: “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 and Cell Q platforms to deliver reliable GMP drug products at scale.”

Cabaletta is developing rese-cel across multiple autoimmune indications, which typically involve larger patient populations than oncology-focused CAR T therapies. This shift in target population has increased pressure on manufacturing processes to deliver consistency, speed and capacity at higher volumes than those required for cancer indications.

Cellares said its automated approach is designed to standardise manufacturing execution across production runs, equipment and sites. The company added that integrating release testing into a digitally enabled workflow is intended to reduce manual handling, shorten cycle times and limit variability in product quality, factors that can affect turnaround times in autologous cell therapy manufacturing.

Ahead of the IND amendment submission, Cabaletta and Cellares generated split apheresis comparability data to assess performance between manual and automated manufacturing processes. The companies said the data demonstrated consistent results across both approaches, supporting the transition to automated clinical production.

In parallel, Cellares completed a concurrent multi-batch engineering run campaign to demonstrate its ability to manufacture GMP product at a scale aligned with Cabaletta’s current clinical needs. The work was designed to show that the automated platforms could support multiple batches simultaneously while maintaining consistency and compliance.

Steven Nichtberger, co-founder, chairman and chief executive officer of Cabaletta Bio, said: “Since we formed our partnership with Cellares in 2023, we believed that their fully automated manufacturing platform had the potential to change the paradigm of autologous cellular therapies by offering the promise of unprecedented scale produced reliably with minimal capital expense. The technical data we generated in collaboration with Cellares supported the IND clearance for clinical manufacturing of rese-cel in our ongoing clinical program. Initial clinical data is anticipated in 1H26 to inform GMP readiness, including supply chain logistics.”

Cabaletta expects early clinical data from the Reset programme in the first half of 2026, which the company said will help guide further manufacturing and supply chain planning as development progresses.