FATE THERAPEUTICS INC · Data as of 2026-09-08
H2 2026
The Company anticipates providing further updates on its clinical progress at European Alliance of Associations for Rheumatology (EULAR) Annual Congress in June of 2026 as well as in other scientific conferences in the second half of 2026.Source filing
2028
RECLAIM-LN: A Phase 2 Potentially Registrational Trial in Lupus Nephritis FT819-201 (RECLAIM-LN) patient enrollment planned to commence in 2H2026 OPEN LABEL, SINGLE ARM STUDY FOR PATIENTS WITH REFRACTORY MODERATE-TO-SEVERE SLE WITH LN1,2 RECLAIM-LN Trial Schema ✓ Single d ose of 900M cells ✓ Less-intensive condit ioning regimen consisting of bendamustin e ✓ Outpatient treatment enabled ✓ Study N= 53 total patients ✓ Validated primary endpoint at 26 weeks ✓ FDA RMAT designat ion & CDRP program There is no Day 0; visit days within the cycle progress from Day -5 to Day -4, followed by Day 1. After FT819 infusion, participants acceptance will be followed in PTFU for up to 2 years after Day 1, followed by LTFU for safety and survival for up to 15 years after Day 1. LTFU = Long-term follow-up; PTFU = Post-treatment follow-up. RECLAIM-LN Trial Features & Design RMAT designation provides enhanced FDA • Single dose of FT819 administered at 900M cells following bendamustine conditioning; each dose engagement and support, strengthening both administration will be supported by on-demand drug product availability clinical & regulatory pathways toward a • Less-intensive fludarabine-free chemotherapy enhances safety, provides a more patient-friendly potential accelerated approval of FT819 experience, and is outpatient enabled • Total enrollment of 53 patients with anticipated commencement of patient dosing in 2H2026; CDRP program acceptance by the FDA aims enrollment expected to complete within 15 months following trial commencement to facilitate the expedited development of • Primary endpoint will assess percent of patients achieving complete renal response (CRR) at 6 months FT819 for accelerated clinical timelines • Trial design informed by feedback received from FDA RMAT meeting RECLAIM-LN potentially registrational trial to be initiated in 2H 2026 with BLA submission targeted in 2028 1. https://clinicaltrials.gov/study/NCT07570862 (ClinicalTrials.gov) RMAT: FDA Regenerative Medicine Advanced Therapy; 2. Learn more about the RECLAIM-LN clinical trial at www.fatetherapeutics.com/patients CDRP: Chemistry, Manufacturing, and Controls Development and Readiness Pilot 16Source filing