The clearance allows the company to begin an early-stage basket trial in multiple autoimmune diseases later this year.
- FT839 is engineered to eliminate a broader range of disease-driving immune cells compared to existing single-target CAR T therapies.
- Enrollment in the basket study is expected to begin in the second half of 2026.
- FT839 is the second CAR T candidate from Fate to enter clinical development for autoimmune diseases.
Shares of Fate Therapeutics Inc (FATE) jumped 6% on Thursday after the U.S. Food and Drug Administration cleared its application to commence a clinical trial for its cell therapy FT839.
The clearance allows the company to begin an early-stage basket trial in multiple autoimmune diseases later this year.
About FATE’s FT839
FT839 is engineered to eliminate a broader range of disease-driving immune cells compared to existing single-target CAR T therapies. The company plans to test it in conditions such as rheumatoid arthritis, systemic lupus erythematosus, ANCA-associated vasculitis, and systemic sclerosis.
Enrollment in the basket study is expected to begin in the second half of 2026. The trial will evaluate FT839 with or without conditioning chemotherapy.
FATE’s Remaining Pipeline
FT839 is the second CAR T candidate from Fate to enter clinical development for autoimmune diseases. Its lead program, FT819, is more advanced and is moving into a potentially registrational mid-stage study in lupus nephritis later this year. FT819 has already shown promising early clinical activity in systemic lupus erythematosus and systemic sclerosis.
Fate Therapeutics is focused on developing off-the-shelf cell therapies that can be manufactured at scale and stored for on-demand use, aiming to overcome many of the limitations of traditional autologous CAR T treatments, where a patient’s own immune cells are extracted, genetically reprogrammed to target specific proteins on abnormal cells, and re-infused to attack the disease.
How Did FATE Retail Traders React?
On Stocktwits, retail sentiment around FATE stock stayed within the ‘neutral’ territory over the past 24 hours, while message volume fell from ‘high’ to ‘normal’ levels.
A Stocktwits user applauded the update on Thursday as “awesome news.”
Another user voiced optimism for a buyout at a premium for Fate Therapeutics.
FATE stock has more than tripled year-to-date.
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