Fate Therapeutics will present Phase 1 FT819 CAR T-cell data in lupus, including kidney outcomes in lupus nephritis, at CCR-West 2026.
Written By: Mayuri Vaja, PharmD
Reviewed By: Pharmacally Editorial Team
Fate Therapeutics will present updated Phase 1 clinical data for its off-the-shelf, iPSC-derived anti-CD19 CAR T-cell therapy FT819 in systemic lupus erythematosus (SLE), including kidney outcomes from patients with lupus nephritis, at the Congress of Clinical Rheumatology West (CCR-West) in Huntington Beach, California, on September 17-20, 2026. The company will also present preclinical findings for FT839, an off-the-shelf dual-CAR T-cell candidate targeting CD19 and CD38, as it expands its CAR T-cell development strategy in autoimmune disease.
FT819 Clinical Data Support Lupus Nephritis Development
The FT819 presentation will include safety, efficacy and translational data from 16 patients treated in Regimen A of an ongoing Phase 1 trial. Thirteen patients had completed at least one month of follow-up at the May 14, 2026 data cutoff.
Regimen A evaluates a single dose of FT819 combined with less-intensive, fludarabine-free conditioning chemotherapy. The approach reduces exposure to conventional lymphodepletion while supporting CAR T-cell treatment in patients with SLE.
The data will support Fate’s advancing RECLAIM-LN program, a Phase 2 potentially registrational trial evaluating FT819 in lupus nephritis (LN).
Off-the-Shelf CAR T Approach Targets B Cells
FT819 is an allogeneic CAR T-cell therapy manufactured from induced pluripotent stem cells (iPSCs). The therapy targets CD19, a B-cell marker, allowing it to eliminate CD19-positive B cells that contribute to autoimmune disease.
Unlike patient-specific autologous CAR T-cell therapies, an iPSC-derived product can be manufactured in advance and administered as an off-the-shelf therapy. Fate has also incorporated targeted insertion of the CAR construct into the TRAC locus and a tuned CAR motif into FT819. The company says these features are intended to control T-cell expansion and support product consistency.
FT819 Shows Favorable Early Safety and Efficacy
Among the SLE patients treated in Regimen A, no dose-limiting toxicities were reported. No patients developed Grade 3 or higher cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD), or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS).
Infections and cytopenias occurred at low and manageable rates.
The treatment also produced early improvements in disease activity and patient-reported outcomes. SLEDAI scores improved following FT819 treatment, while FACIT-Fatigue scores indicated improvements in fatigue. According to Fate, these changes emerged within the first month of treatment and were maintained over time.
Kidney Data Support RECLAIM-LN
The most directly relevant findings for lupus nephritis came from patients with active LN at baseline. At month six, urine protein-to-creatinine ratio (UPCr) decreased by 1.15 g/g across all patients treated in Regimen A.
Among patients who received a single dose of FT819 with bendamustine, UPCr declined by 1.8 g/g. UPCr is an important measure of proteinuria and kidney disease activity in lupus nephritis, making the reduction a clinically relevant signal as Fate moves the program toward a dedicated Phase 2 study.
FT839 Expands the Autoimmune CAR T Strategy
Fate will also present preclinical data for FT839, an off-the-shelf dual-CAR T-cell therapy targeting both CD19 and CD38.
The dual-target approach is intended to broaden immune-cell depletion beyond CD19-positive B cells by also targeting CD38-expressing cells, including plasma-cell populations. The presentation will evaluate the potential of FT839 to target both B- and T-cell compartments in autoimmune disease without preconditioning.
Path Forward for Fate’s CAR T Pipeline
Both presentations are scheduled for September 18 at 3:40 p.m. PT during CCR-West. The FT819 findings provide an updated clinical assessment of the therapy’s safety and activity under reduced conditioning and add kidney-specific data relevant to its lupus nephritis development path.
Fate’s next major step is the advancement of FT819 into RECLAIM-LN, while FT839 remains at the preclinical stage. Together, the programs reflect the company’s broader effort to apply iPSC-derived, off-the-shelf CAR T-cell therapies beyond oncology and into autoimmune diseases such as lupus.
Reference
Fate Therapeutics Announces Encore Clinical Data Presentation of FT819 Off-the-Shelf CAR T-Cell Product Candidate at the CCR – West 2026 Meeting, Fate Therapeutics, 09 September 2026
About the Writer
Mayuri Vaja (Linkedin) is a PharmD professional with a strong interest in clinical research, pharmacovigilance, and medical writing, supported by certifications in pharmacovigilance and academic projects exploring AI in healthcare and drug safety.
With a growing focus on evidence-based healthcare and scientific communication, she is developing expertise in clinical research and translating healthcare evidence into clear, meaningful content.
As a Pharmacally healthcare writer, Mayuri is committed to creating accurate, research-driven, and clinically relevant healthcare content while continuously strengthening her professional skills.