Fate Therapeutics to Dose 900M Cells in 53-Patient Phase 2 Lupus Trial
FATE•Fate Therapeutics plans to initiate RECLAIM-LN, a Phase 2 registrational trial dosing 900 million FT819 cells in approximately 53 lupus nephritis patients in the second half of 2026, leveraging its RMAT designation and inclusion in FDA’s CDRP program for accelerated CMC review. The company cut operating expenses by 20% year-over-year, extending cash runway into 2028.
1. Financial Results and Runway Extension
Fate Therapeutics reported a 20% reduction in operating expenses in Q1 2026 versus Q1 2025, extending its cash runway into 2028. The cost savings were driven by streamlined operations and prioritized resource allocation, bolstering the company’s ability to advance multiple clinical programs without near-term financing.
2. RECLAIM-LN Phase 2 Trial Plan
The company expects to initiate RECLAIM-LN (FT819-201), a single-arm Phase 2 trial enrolling about 53 patients with refractory moderate-to-severe systemic lupus erythematosus with lupus nephritis in H2 2026. Patients will receive a single 900 million-cell infusion following a reduced bendamustine conditioning regimen, with complete renal response at six months as the primary endpoint.
3. FDA CDRP and RMAT Designations
FT819 has secured RMAT designation and been selected for the FDA’s CMC Development and Readiness Pilot (CDRP) program, granting enhanced regulatory engagement on manufacturing and control activities. These designations aim to streamline development timelines and support an accelerated registration pathway for FT819 in lupus nephritis.
4. Ongoing FT819-102 Phase 1 Clinical Trial
The multi-center Phase 1 FT819-102 trial is enrolling patients across four autoimmune indications: SLE, systemic sclerosis, idiopathic inflammatory myositis and AAV. As of May 5, 2026, 27 patients have been dosed—19 with SLE and eight in other cohorts—of which eight received FT819 in an outpatient setting without intensive conditioning chemotherapy.
