FDA Clears IND Amendment for Cabaletta Bio’s Rese-cel Clinical Manufacturing

Reuters01-12

FDA Clears IND Amendment for <a href="https://laohu8.com/S/CABA">Cabaletta Bio</a>’s Rese-cel Clinical Manufacturing

Cabaletta Bio Inc. has received FDA clearance of an Investigational New Drug $(IND)$ Amendment to use Cellares' automated Cell Shuttle™ and Cell Q™ platforms for the manufacturing and quality control release testing of its investigational CAR T cell therapy, rese-cel (resecabtagene autoleucel). This regulatory approval enables clinical manufacturing and release of rese-cel using these automated systems, with the first patient dosing anticipated in the first half of 2026 as part of Cabaletta's RESET™ clinical trial program. This marks the first use of the Cell Shuttle and Cell Q platforms to support an active clinical program.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cabaletta Bio Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260112892556) on January 12, 2026, and is solely responsible for the information contained therein.

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