IND Amendment Clearance Obtained for Clinical Manufacturing of Rese-Cel from Cabaletta Bio Using Cellares' Automated Platforms
Cabaletta Bio, Inc. (CABA)
Company Research
Source: Business Wire
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.“Autoimmu
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Earnings
- 11/10/25 - Beat
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Analyst Actions
- 10/31/25 - Cantor Fitzgerald
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Sec Filings
- 1/12/26 - Form 8-K
- 11/14/25 - Form SCHEDULE
- 11/14/25 - Form SCHEDULE
- CABA's page on the SEC website