IND Amendment Clearance Obtained for Clinical Manufacturing of Rese-Cel from Cabaletta Bio Using Cellares' Automated Platforms

Key Terms

gmp medical

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

car t cell therapy medical

A therapy that engineers a patient's own immune cells (T cells) so they can recognize and kill cancer cells, like retraining a guard dog to detect a specific scent. It matters to investors because these treatments can be transformative and command high prices, yet require complex manufacturing and face regulatory, safety and reimbursement risks that can greatly influence a biotech or drugmaker’s valuation and future revenue.

ind amendment regulatory

An IND amendment is an official update to an Investigational New Drug filing submitted to a regulatory agency (for example, the U.S. Food and Drug Administration) that changes how a medicine or clinical trial will be made, tested or monitored. It matters to investors because these updates can enable new trial stages, add manufacturing or safety controls, or address problems—similar to updating a recipe or blueprint—and can speed, delay or protect the value of a drug development program.

qc technical

Quality control (QC) is the set of checks and tests a company uses to make sure its products or services meet expected standards before reaching customers. For investors, QC matters because strong, consistent QC reduces the risk of recalls, regulatory fines, production delays, and reputational damage—like a restaurant double‑checking each dish before it leaves the kitchen to avoid food safety problems and unhappy customers.

autologous cellular therapies medical

A treatment that uses a patient’s own cells, taken out, sometimes changed or grown in a lab, and then put back into the same person to fight disease — like harvesting seeds from one plant to grow a stronger version for that same garden. Investors care because these therapies can be highly personalized and potentially long-lasting, but they also involve complex, costly manufacturing, regulatory hurdles and scaling risks that affect commercial upside and valuation.

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.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced that Cabaletta Bio’s (Nasdaq: CABA) investigational CAR T cell therapy rese-cel (resecabtagene autoleucel) has received FDA clearance of an IND Amendment (INDa) to use Cellares’ Cell Shuttle™ and Cell Q™ platforms for manufacturing and QC release testing.

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 Steven Nichtberger, M.D., Co-founder, Chairman, and Chief Executive Officer of Cabaletta Bio. “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.”

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.

About Cabaletta Bio

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables biopharmaceutical partners to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.

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.

Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.

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Source: Cellares