Fate Therapeutics Treats 19 Autoimmune Patients Outpatient with FT819 CAR T
Fate Therapeutics has treated 19 autoimmune patients across 16 U.S., U.K. and EU sites in its FT819-102 Phase 1 basket trial using off-the-shelf CAR T-cell therapy in an outpatient setting. Early data include meaningful disease improvement in a systemic sclerosis patient at a three-month evaluation.
1. Trial Design and Enrollment
Fate Therapeutics initiated its FT819-102 Phase 1 basket trial across 16 sites in the U.S., U.K. and EU, enrolling 15 systemic lupus erythematosus patients and four systemic sclerosis patients to evaluate its off-the-shelf CAR T therapy in autoimmune diseases.
2. Outpatient Treatment Milestone
The company successfully administered FT819 in an outpatient setting, eliminating the need for extended hospitalization and streamlining patient access to CAR T-cell therapy.
3. Early Efficacy Outcomes
Initial data include meaningful disease improvement in the first systemic sclerosis patient at a three-month evaluation, with safety parameters consistent with outpatient administration and no severe adverse events reported thus far.
4. Future Development Plans
Fate plans to continue enrollment to complete its Phase 1 basket trial, analyze comprehensive safety and efficacy data, and prepare for potential Phase 2 studies to expand indications and patient access.