Abstract: SA-OR050
Off-the-Shelf Anti-CD19 Chimeric Antigen Receptor (CAR)-T Cell Therapy with Less-Intensive Fludarabine-Free Conditioning in Lupus Nephritis: Phase 1 Safety and Efficacy
Session Information
- Glomerular Diseases: Clinical Trial Results
October 24, 2026 | Location: Mile High Ballroom 4A, Convention Center
Abstract Time: 05:10 PM - 05:20 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Pang, Shirley W., St. Jude Medical Center, Providence Medical Foundation, Fullerton, California, United States
- Medlin, Jennifer, University of Nebraska Medical Center, Omaha, Nebraska, United States
- Fazeli, Parastoo, University of Minnesota, Minneapolis, Minnesota, United States
- Desai, Sheetal, University of California Irvine, Irvine, California, United States
- Graf, Jonathan David, University of California San Francisco, San Francisco, California, United States
- Thanou, Aikaterini, University of Oklahoma, Oklahoma City, Oklahoma, United States
- Parker, Ben, Manchester University Hospitals, Manchester, United Kingdom
- Wang, Shudan, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, United States
- Singer, Nora G., The MetroHealth System, Cleveland, Ohio, United States
- Leonard, Dag, Uppsala University, Uppsala, Sweden
- Elsedawy, Noura, University of Tennessee Health Science Center, Memphis, Tennessee, United States
- Pattanaik, Debendra, University of Tennessee Health Science Center, Memphis, Tennessee, United States
- Bethune, Claudette, Fate Therapeutics Inc, San Diego, California, United States
- Bitmansour, Andrew, Fate Therapeutics Inc, San Diego, California, United States
- Greene, Trever, Fate Therapeutics Inc, San Diego, California, United States
- Wong, Lilly, Fate Therapeutics Inc, San Diego, California, United States
- Wong, Carol, Fate Therapeutics Inc, San Diego, California, United States
- Ferguson, Beatrice, Fate Therapeutics Inc, San Diego, California, United States
- Valamehr, Bob, Fate Therapeutics Inc, San Diego, California, United States
- Sandhu, Vaneet, Fate Therapeutics Inc, San Diego, California, United States
- Shiff, Natalie J., Fate Therapeutics Inc, San Diego, California, United States
Background
FT819 is an investigational off-the-shelf anti-CD19 CAR T-cell product derived from an induced pluripotent stem cell (iPSC) clonal master cell bank, designed to be mass produced and administered in the outpatient setting. We report preliminary efficacy and safety in patients with lupus nephritis (LN) from a Phase 1 basket study of FT819 in autoimmune diseases (SLE/LN, AAV, SSc, IIM; NCT06308978).
Methods
LN patients met ACR/EULAR criteria, were refractory to ≥2 immunosuppressants, had ≥1 autoantibody, and SLEDAI-2K ≥8 plus 1 BILAG A or 2 BILAG B scores. Patients received a single FT819 dose after fludarabine-free conditioning chemotherapy (CCT; cyclophosphamide x1 or bendamustine x2.; Regimen [Reg] A) or without CCT (Reg B). Hydroxychloroquine and ≤10 mg prednisone equivalent were allowed. Dose levels: 3.6 x 108 or 9 x 108 viable cells.
Results
Eight patients with LN were treated with FT819 in Reg A; 87.5% were female, with a mean age 31 years. At baseline (BL), mean UPCr was 2.70 ± 1.866 (±SD) and median SLEDAI-2K was 12 (range, 8-20). Clinically meaningful improvements were seen in UPCr, SLEDAI-2K (including cSLEDAI-2K), PGA, and FACIT-Fatigue (Figure 1). Complete renal response was observed in 2/4 patients with ≥6 months of follow-up. No Grade >1 CRS was reported; no dose-limiting toxicity, ICANS, GvHD, or deaths occurred on study. Updated data will be presented.
Conclusion
Preliminary data in patients with LN treated with FT819 combined with fludarabine-free CCT demonstrate favorable safety and tolerability, as well as encouraging clinical efficacy, supporting further development in LN.
Figure 1: Disease Activity in Regimen A, Lupus Nephritis
Funding
- Other U.S. Government Support – Fate Therapeutics, Inc.