IND Amendment Clearance Obtained for Clinical Manufacturing of Rese-Cel from Cabaletta Bio Using Cellares' Automated Platforms
The first GMP cell therapy product ever manufactured for clinical use on the Cell Shuttle™ and released using Cell Q™, is expected to be infused into patients within Cabaletta’s RESET™ clinical trial program in the first half of 2026.
The clearance allows for the clinical manufacturing and release of rese-cel using Cellares’ fully automated end-to-end manufacturing and high-throughput quality control platforms, with first patient dosing anticipated in the first half of 2026. This milestone marks the Cell Shuttle and Cell Q platforms’ first use to support an active clinical program.
“Autoimmune cell therapy programs operate at a fundamentally different scale of patient demand than oncology,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. “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 advancing rese-cel across autoimmune indications with substantially larger patient populations than traditional oncology CAR T therapies, heightening the need for scalable, reliable, and operationally efficient manufacturing. The Cell Shuttle’s end-to-end automation enables standardized and consistent execution across runs, equipment, and sites, while Cell Q integrates release testing into a high-throughput, digitally enabled workflow. Implementation of the Cell Shuttle and Cell Q platforms reduces manual touchpoints, cycle times, and variability, thereby improving turnaround time and consistency in quality.
In preparation for the submission, Cabaletta and Cellares generated split apheresis comparability data demonstrating consistent performance between manual and automated manufacturing processes, supporting the transition to automated clinical production on Cellares’ technology platforms. In addition, Cellares executed a concurrent multi-batch engineering run campaign to demonstrate the capability for GMP manufacturing at a scale that meets the current clinical demand.
“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,” said
About Rese-cel
Rese-cel (formerly referred to as CABA-201) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion, rese-cel is intended to transiently and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy. Cabaletta is evaluating rese-cel in the RESET™ (REstoring SElf-Tolerance) clinical development program, which includes multiple ongoing company-sponsored trials across a diverse and growing range of autoimmune diseases in rheumatology, neurology and dermatology.
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About Cellares
Cellares is the first
Cellares’ fully automated platforms - Cell Shuttle™ for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control - are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry.
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