FT819-102

May 13, 2026: Fate Therapeutics, Inc. (NASDAQ: FATE) reported Q1 2026 results and outlined multiple upcoming clinical/regulatory catalysts across its off-the-shelf iPSC-derived CAR T-cell pipeline.

FT819 (CD19 CAR T) – autoimmune (SLE/lupus nephritis and others):

• RECLAIM–LN / FT819-201 (NCT07570862): Phase 2 “potentially registrational” open-label, single-arm trial in refractory moderate-to-severe SLE with lupus nephritis is on track to start patient dosing in 2H 2026. ~53 patients; single 900M-cell dose after bendamustine conditioning; primary endpoint complete renal response at 6 months; enrollment targeted to complete ~15 months after start.
• Regulatory/CMC: FDA selected FT819 for the CMC Development and Readiness Pilot (CDRP) program; FT819 also has RMAT designation.
• FT819-102 Phase 1 (NCT06308978): enrolling at 18 sites across SLE, systemic sclerosis, idiopathic inflammatory myositis, and AAV; as of May 5, 2026, 27 patients treated (19 SLE; 8 other), including 8 outpatient. ASGCT 2026 (data cutoff Apr 9, 2026) Regimen B (no conditioning) dose level 1 (360M): 3/3 achieved SRI-4 and 2/3 achieved LLDAS; now dosing 900M and exploring repeat dosing. Further updates planned at EULAR June 2026 and other 2H 2026 conferences. PRSYM 2026/CCR-East 2026 data (13 SLE; cutoff Dec 23, 2025) showed mean improvements at Month 6: SLEDAI-2K -13, PGA -1.75, UPCr -1.14 mg/mg; FACIT-Fatigue +23.4 at Month 3.

FT839 (CD19/CD38 dual-CAR): IND planned for a Phase 1 basket autoimmune study; enrollment expected to begin 2H 2026. Preclinical data presented at AACR April 2026; additional presentations expected at ASGCT May 2026 and EULAR 2026.

FT836 (MICA/B CAR T) – solid tumors: Ongoing Phase 1 enrolling without conditioning chemotherapy; as of Apr 20, 2026, nine patients treated (including cetuximab and trastuzumab combination arms). Reported no ICANS, GvHD, CRS, or DLTs at dose level 1 of the cetuximab arm. Updated clinical data expected at ASCO June 2026. FDA cleared an IND for an investigator-initiated trial of FT836 + daratumumab in multiple myeloma at the Medical College of Wisconsin; patient treatment expected mid-2026.

Financials: Cash/investments $174.8M (Mar 31, 2026); operating runway extended into 2028. Q1 2026 net loss $31.2M; operating expenses $34.3M; revenue $1.3M (Ono collaboration).