FT819 / Fate Therapeutics, Memorial Sloan-Kettering Cancer Center - LARVOL DELTA

Patient Perspectives on Allogeneic CAR T Cell Therapy in Systemic Lupus Erythematosus: Findings from a Focus Group Study (Part 3) (ACR Convergence 2026) - "Interest in FT819 was high but explicitly conditional. Participants prioritized SLE-specialist care, upfront financial support, and a side effect profile commensurate with duration of benefit, with priority towards safety and efficacy. Findings can inform patient education and care delivery strategies to support equitable, patient-centered implementation."

CAR T-Cell Therapy • Clinical • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Off-the-shelf Anti-CD19 CAR T-cell Therapy Efficacy Reveals Biomarker Candidates for Fatigue in SLE (ACR Convergence 2026) - "Pts received a single FT819 dose after fludarabine-free conditioning chemotherapy (CCT; cyclophosphamide x1 or bendamustine x2). These preliminary data show that fatigue responses in the pts treated with FT819 well exceed MCID. Our early analysis in these pts has identified changes in B cell subsets, which are associated with improvement in fatigue (FACIT-F). Further study will be needed to expand these observations."

Biomarker • CAR T-Cell Therapy • Clinical • Fatigue • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Off-the-Shelf CD19 CAR T-cell Therapy Demonstrates Feasibility of Outpatient Administration, Expanding Access to Community-Based Care (ACR Convergence 2026) - P1 | "Reg A pts received a single FT819 dose after fludarabine-free CCT (cyclophosphamide x 1 or bendamustine x 2). Antimalarials and ≤10 mg/day oral prednisone (glucocorticoid) equivalent was permitted... Preliminary data from 5 pts with autoimmune disease treated on-demand with outpatient administration of FT819 demonstrate a favorable safety profile, supporting continued evaluation of outpatient dosing. Education materials were also developed to support sites and pts with outpatient monitoring following cell therapy infusion. Outpatient administration has the potential to expand access to underserved and geographically distant pts while reducing healthcare utilization and associated costs."

CAR T-Cell Therapy • Clinical • ANCA Vasculitis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

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 (KIDNEY WEEK 2026) - P1 | "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...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"

Clinical • P1 data • Glomerulonephritis • Graft versus Host Disease • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Fate Therapeutics Selected for Four Presentations Highlighting its Off-the-Shelf CAR T-Cell Portfolio in Autoimmune Disease at ACR Convergence 2026 (Fate Therapeutics Press Release) - "Presentations span clinical, translational, and patient-centered research across the Company’s autoimmune focused, off-the-shelf, iPSC-derived CAR T-cell pipeline, including FT819 and FT839. Two FT819 presentations will feature updated clinical data, including administration of FT819 without the use of conditioning chemotherapy, the overview of a unique biomarker association with quality-of-life improvement, and continued progress on outpatient administration to expand community-based access, including in underserved regions. A third presentation details a patient perspective focus group study conducted in collaboration with the Lupus Foundation of America, which explores patient preferences for off-the-shelf, allogeneic CAR T-cell therapy in lupus. The final presentation will provide an update on preclinical studies and the design and progress of the COMPLETE Trial, a recently cleared Phase 1/2 clinical trial of FT839..."

Clinical protocol • P1 data • P2 data • Preclinical • Trial status • Lupus • Lupus Nephritis • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Fate Therapeutics Announces Receipt of California Institute for Regenerative Medicine (CIRM) CLIN2 Grant to Advance RECLAIM-LN (GlobeNewswire) - "$15.0 Million Award to Support Advancement of RECLAIM-LN, a Phase 2 Potentially Registrational Trial of FT819 Off-the-Shelf CAR T-Cell Therapy in Lupus Nephritis."

Financing • Lupus Nephritis • Systemic Lupus Erythematosus

Fate Therapeutics Announces Encore Clinical Data Presentation of FT819 Off-the-Shelf CAR T-Cell Product Candidate at the CCR – West 2026 Meeting (GlobeNewswire) - "Early and Maintained Efficacy: As of the cutoff date, clinically meaningful improvements were observed in lupus disease activity and patient-reported outcome measures, including Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue scores, in patients treated in the Phase 1 trial. Improvements were observed early following treatment with FT819 using less-intensive conditioning therapy in Regimen A (≥1-month follow-up) and were maintained over time."

P1 data • Immunology • Systemic Lupus Erythematosus

RECLAIM-LN: A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis (clinicaltrials.gov) - P2 | N=53 | Recruiting | Sponsor: Fate Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Fate Therapeutics Initiates Potentially Registrational RECLAIM-LN Clinical Trial of FT819 for the Treatment of Lupus Nephritis (Fate Therapeutics Press Release) - "Study expected to enroll approximately 53 patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with Class III or IV lupus nephritis; study anticipated to complete enrollment in 15-18 months, by 1H2028....Patients to receive a single 900 million-cell dose of off-the-shelf FT819 following less-intensive conditioning with bendamustine; complete renal response at Week 26 is the primary endpoint."

Trial completion date • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus

Fate Therapeutics to Present Preliminary Clinical Data of FT819 Off-the-Shelf CAR T-Cell Product Candidate for Systemic Sclerosis at the ISSCR 2026 Annual Meeting (Yahoo Finance) - "Highlights of the presentation include data from the first four SSc patients treated as of the June 12, 2026 data cutoff. Three of the four patients were treated under Regimen A with less-intensive conditioning chemotherapy (cyclophosphamide or bendamustine alone) and one patient was treated under Regimen B with no conditioning chemotherapy. All participants demonstrated a Revised Composite Response Index in Systemic Sclerosis (rCRISS)25 or higher with meaningful mean improvement in the Modified Rodnan Skin Score (mRSS) at 3 months post treatment. The treatment was well tolerated with no Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Graft versus Host Disease (GvHD), hypogammaglobulinemia, or deaths reported in SSc participants on study."

P1 data • Systemic Sclerosis

Title: Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy with Reduced Conditioning in SLE: A Phase 1 Study Supporting Same-Day Discharge (GlobeNewswire) - "FT819 maintained a favorable safety profile and across key disease activity endpoints, drove deep and sustained efficacy responses with depth of response greater with bendamustine compared to cyclophosphamide...The UPCr panel of Figure 4 shows a rapid decrease in proteinuria within the first few months, with bendamustine-treated patients exhibiting the most pronounced and sustained decrease...Glucocorticoid reduction: Of 10 patients entering the trial on background glucocorticoids with ≥1 month of follow-up, 7 achieved a dose of ≤5 mg/day, 5 of whom discontinued steroids altogether....B-cell reset after FT819 treatment was further confirmed by B-cell receptor sequencing demonstrating a 74–96% reduction in the top 50 most expanded clones at baseline in all patients analyzed (n=5)."

P1 data • Systemic Lupus Erythematosus

Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy With Reduced Conditioning in SLE: A Phase 1 Study Supporting Same-Day Discharge (EULAR 2026) - P1 | "Pts received a single dose of FT819 under 1 of 2 regimens (Reg): Reg A, discontinuation of immunosuppressives followed by fludarabine-free conditioning chemotherapy (CCT) with either single-dose cyclophosphamide (CY) or bendamustine daily for 2 days prior to FT819; or Reg B, no CCT with continued stable maintenance therapy, including mycophenolate. Hydroxychloroquine and ≤10 mg prednisone (glucocorticoid [GC]) equivalent were permitted...A trend toward more rapid reduction in disease activity was observed at the higher dose level (DL2). These findings support the continued evaluation of FT819 in SLE and other AI diseases with a potential path to a registrational study and ambulatory treatment with same-day discharge."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Glomerulonephritis • Graft versus Host Disease • Hematological Disorders • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

FT819 Drives B cell Compartment Remodeling of Patients with Systemic Lupus Erythematosus Without Conditioning Chemotherapy (ASGCT 2026) - P1 | "With its unique off-the-shelf patient accessibility advantage, preferred safety profile, promising initial efficacy and compatibility with standard-of-care treatments, FT819 has the potential to serve as an ideal therapeutic option for patients with autoimmune diseases, including those in underserved regions. This study is actively enrolling, and updated translational data will be presented."

Clinical • IO biomarker • ANCA Vasculitis • Graft versus Host Disease • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

FT819-102 Phase 1 clinical trial now enrolling in 18 clinical sites globally (GlobeNewswire) - "The study is enrolling patients across four autoimmune disease indications: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myositis (IIM), and anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). As of May 5, 2026, enrollment stands at: Nineteen SLE patients across the two regimens have been treated; Eight patients have been treated across SSc, IIM and AAV; Of these 27 patients, 8 have been treated in an outpatient setting...The Company is now treating patients at dose level 2 (900 million cells) in Regimen B and exploring a repeat-dose paradigm without the use of conditioning chemotherapy...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."

P1 data • Trial status • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

RECLAIM-LN, Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe SLE with lupus nephritis (GlobeNewswire) - "The planned open-label, single-arm study was developed during interactions with the FDA under the RMAT designation for FT819, and is expected to enroll approximately 53 patients, evaluating a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response (CRR) at six months as the primary endpoint...Based on enrollment cadence in the Phase 1 clinical trial and current clinical site engagement, the unique on-demand availability of FT819, and the option for outpatient treatment with reduced conditioning chemotherapy requirements, the Company aims to complete the enrollment of the RECLAIM – LN clinical study approximately 15 months from commencement."

Trial status • Lupus Nephritis

Fate Therapeutics Showcases FT819 Clinical Activity in SLE without the use of Conditioning Chemotherapy at the 2026 ASGCT Annual Meeting (GlobeNewswire) - "Single dose treatment of FT819 without conditioning chemotherapy achieves lupus low disease activity state (LLDAS) in active SLE Patients; durable B cell remodeling is exhibited by depletion of major B cell clones up to 12 months following treatment with B cell shift towards less class-switched BCR repertoire."

P1 data • Immunology • Systemic Lupus Erythematosus

RECLAIM-LN: A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis (clinicaltrials.gov) - P2 | N=53 | Not yet recruiting | Sponsor: Fate Therapeutics

New P2 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Fate Therapeutics Announces Data Presentation of FT819 Off-the-Shelf CAR T-Cell Product Candidate for Systemic Lupus Erythematosus (SLE) at the CCR – East 2026 Meeting (GlobeNewswire) - "Highlights of the presentation include data from the first 10 SLE patients treated in Regimen A illustrating clinically meaningful improvements in disease activity and patient-reported outcome measures following a single dose treatment of FT819 combined with less-intensive fludarabine-free conditioning chemotherapy, among patients with at least 1 month of follow-up. These response were observed early and were maintained over time, as demonstrated by, i) SLEDAI-2K: Scores decreased by 13 points from baseline at Month 6 (mean ± SEM), ii) PGA: Scores decreased by 1.75 points from baseline at Month 6 (mean ± SEM)​; iii) UPCr: Levels decreased by 0.90 and 1.14 mg/mg from baseline at Months 3 and 6, respectively (mean ± SEM)​, and iv) FACIT-Fatigue: Scores improved by 23.4 ± 5.98 and 24.3 ± 3.07 points from baseline at Months 3 and 6, respectively (mean ± SEM)."

P1 data • Systemic Lupus Erythematosus

Fate Therapeutics Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of FT819 (GlobeNewswire) - "The program provides increased communication with the FDA, including additional CMC-focused Type B meetings to help clarify development strategies, address key questions, and support manufacturing readiness, ultimately helping to ensure that the CMC readiness for marketing keeps pace with expected faster clinical timelines, so that product approvals are not held up by CMC bottlenecks....'The selection into the CDRP program, combined with our RMAT designation, is intended to accelerate our manufacturing readiness as we embark on our Phase 2 potentially registrational clinical trial in SLE.'"

Commercial • New P2 trial • Systemic Lupus Erythematosus

Upcoming catalysts and cash runway (Yahoo Finance) - "On timelines, Valamehr said Fate expects an update at EULAR and a more comprehensive durability update at ACR...On enrollment for lupus nephritis, he said a single-arm study could be completed in 12 to 18 months and that he no longer 'lose[s] sleep' over enrollment given recent acceleration."

P1 data • Trial completion date • ANCA Vasculitis • Lupus Nephritis • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis

FT819 in lupus and other autoimmune diseases: safety, early efficacy signals, and trial strategy (Yahoo Finance) - "Discussing safety, Valamehr said that as of the data cutoff there were no Grade 3 or higher cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GVHD)...Beyond systemic lupus erythematosus (SLE), Valamehr said Fate is treating patients in systemic sclerosis, vasculitis, and myositis, and shared a systemic sclerosis case study in which multiple assessments trended in the right direction....He also said Fate plans to pursue a Phase II single-arm, 'potentially registration-enabling' study in lupus nephritis, with complete renal response at six months as the primary endpoint, first focusing on lupus nephritis and then extrarenal lupus. He said systemic sclerosis could be a subsequent Phase II opportunity if data continues to support expansion."

New P2 trial • Trial status • ANCA Vasculitis • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Fate Therapeutics…CEO Bob Valamehr outlined the company’s clinical and manufacturing strategy for FT819, an off-the-shelf allogeneic CAR T-cell therapy, during a conference fireside chat hosted by Leerink Partners senior equity research analyst Daina Graybosch. (MarketBeat) - "Valamehr said Fate has held several FDA meetings under RMAT designation and is preparing to start a Phase II, potential registration-enabling trial in lupus nephritis in the second half of the year. He said the study is planned as a single-arm trial with complete renal response as the primary endpoint, and that the company believes it can enroll quickly...He said Fate expects to strengthen these observations with additional conference updates and anticipated treating approximately 25 lupus patients by the summer timeframe, with about 15 patients having six-month follow-up by mid-year."

New P2 trial • Lupus Nephritis

FT819-102: FT819 in B-cell Mediated Autoimmune Diseases (clinicaltrialsregister.eu) - P1 | N=50 | Recruiting | Sponsor: Fate Therapeutics Inc.

New P1 trial • Immunology

Clinical Development & Program Updates: FT819 (GlobeNewswire) - "FT819-102 Phase 1 clinical trial now enrolling in 16 clinical sites across the U.S., U.K. and E.U....Fifteen SLE patients across the two regimens have been treated, as of February 25th; Four SSc patients have also been treated in the two regimens as of February 25th....One IIM patient has also been treated, as of February 25th....The Company expects to provide clinical, regulatory, and operational updates in the second half of 2026."

Trial status • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis

Fate Therapeutics Presents Updated Phase 1 Clinical Data of FT819 Off-the-shelf CAR T-cell Product Candidate for Systemic Lupus Erythematosus… (GlobeNewswire) - "...first systemic sclerosis (SSc) patient treated...With the strength of this clinical data, the Company continues to advance preparations for a pivotal study and is engaged in discussions with the United States Food and Drug Administration (FDA) under its Regenerative Medicine Advanced Therapy (RMAT) designation regarding plans to initiate registrational trial of FT819 in 2026...Preliminary data in Regimen A (with patients receiving a single FT819 dose after pretreatment with either a single dose of cyclophosphamide or two doses of bendamustine) show mean SLEDAI-2K score across both dose levels (DL1, 360 million cells; DL2, 900 million cells) decreased progressively from baseline: DL1 SLEDAI-2K score decreased from a mean of 15.2 (n=5) at baseline to a mean of 10 at month 3 (n=2), and to a mean of 6 at month 6 (n=2), representing mean percent drops of 50% and 70%, respectively..."

New trial • P1 data • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis