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# Talaris Reports FREEDOM-1 Study Death
- URL: https://www.fdaweb.com/talaris-reports-freedom-1-study-death/
- Published: 2022-10-20T12:00:00.000Z
- Updated: 2026-09-14T18:03:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153015

Talaris Therapeutics says it learned on 10/18 of the death of a subject enrolled in its FREEDOM-1 Phase 3 trial of FCR001 in living donor kidney transplant patients. A company [statement](https://ir.talaristx.com/news-releases/news-release-details/talaris-therapeutics-provides-update-freedom-1-phase-3-clinical?ref=fdaweb.com) says the subject was one of three reported in June to have been diagnosed with grade 2 acute graft-vs-host disease. The company says the other two subjects diagnosed with the disease have experienced a complete resolution of their symptoms.

The death triggered a pre-specified temporary stopping requirement and review by the data monitoring committee, Talaris says. The committee determined that enrollment and dosing could continue, and the company reported the incident and the committee recommendation to FDA, it says.