Catalyst overview
Research summary
This catalyst tracks a Phase 1 update for FT819 (CAR-19, TCR-KO) in Systemic lupus erythematosus. The expected timing is based on the latest available company guidance and may change.
3/5/25- Initiated DE study. 11/13/25:- Updated Ph1 SLE data at ACR 2025; robust responses, favorable safety, first SSc patient treated with FT819. 12/08/25:- Updated data at ASH 2025; durable responses, favorable safety; registrational trial initiation planned 2026. 02/26/26:- Dosing ongoing; enrollment expanding; clinical/regulatory updates in H2 2026. 05/04/26:- ASGCT 2026 poster presents Regimen B Ph1 SLE clinical and translational data May 12, 2026. 05/05/26:- FDA selected FT819 for CDRP; RMAT supports Phase 2 potentially registrational SLE study planning. 05/11/26:- Regimen B cutoff Apr 9 showed LLDAS in 2/3. Dose level 2 initiated. 05/13/26:- FT819-102 Phase 1 SLE cohorts expanding; Regimen B dose level 2; EULAR June 2026 data update planned. 05/21/26:- EULAR 2026 poster tour presents Ph1 SLE safety and efficacy data on June 4, 2026. 06/04/26:- EULAR Ph1 SLE update (May 14 cutoff): 21 treated; outpatient dosing; durable responses; no Grade ≥3 CRS/ICANS. 08/13/26:- EULAR Ph1 SLE data detailed durable responses and favorable safety in 21 treated patients.
Verification
Confirm timing and program details against the company announcement or filing.