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

Treatment of Refractory Systemic Lupus Erythematosus with Off-the-Shelf iPSC-derived Anti-CD19 CAR T-cell Therapy (EULAR 2025) - P1 | "Regimen A is a single dose of FT819 following treatment with fludarabine-free preconditioning chemotherapy consisting of either cyclophosphamide (CY) or bendamustine...All patients reported a median of 8 prior therapies (range 7-8) to treat their SLE, including rituximab...At the time of study entry, all patients continued baseline hydroxychloroquine therapy, and two patients continued low dose corticosteroids... Preliminary data from the first three patients in this clinical trial indicate favorable safety profile, effective B cell depletion with reconstitution of more naïve B cells, and promising initial efficacy. These findings support the continued evaluation of FT819 in SLE and expansion to other B-cell mediated autoimmune diseases, including ANCA-associated vasculitis, idiopathic inflammatory myositis, and systemic sclerosis. This initial report highlights the entry of off-the-shelf anti-CD19 CAR T-cell therapy into the clinical trial landscape, with..."

CAR T-Cell Therapy • IO biomarker • ANCA Vasculitis • Fatigue • Glomerulonephritis • Graft versus Host Disease • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Fate Therapeutics Announces Updated Clinical Data for FT819 Off-the-shelf CAR T-cell Product Candidate Demonstrating Durability of Drug-free Remission for Severe Lupus Nephritis at EULAR 2025 Congress (GlobeNewswire) - P1 | N=244 | NCT06308978 | Sponsor: Fate Therapeutics | "All three patients treated with FT819 following fludarabine-free conditioning regimen for severe lupus nephritis achieve Primary Efficacy Renal Response (PERR); first patient to reach 1-year follow-up continues in drug-free Definition of Remission in SLE (DORIS); First extrarenal SLE patient on maintenance therapy treated with FT819 in the absence of conditioning achieves Low Lupus Disease Activity State (LLDAS) at 3-month follow-up and maintained at 6 months; Cumulative clinical experience in nearly 60 patients treated with off-the-shelf program across autoimmunity and oncology continues to support therapeutic differentiation with favorable safety profile and short duration of hospitalization."

P1 data • Lupus Nephritis • Systemic Lupus Erythematosus

Fate Therapeutics Announces Phase 1 Data Presentation of FT819 Off-the-Shelf CAR T-cell Product Candidate for SLE at EULAR 2025 Congress (GlobeNewswire) - "The Company has been selected to provide an oral presentation featuring clinical data from its ongoing Phase 1 clinical trial of FT819, its off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate, in patients with moderate-to-severe systemic lupus erythematosus (SLE) (NCT06308978). The Phase 1 study is designed to evaluate the safety and activity of FT819 in patients receiving either a fludarabine (flu)-free conditioning regimen or maintenance therapy without conditioning."

P1 data • Systemic Lupus Erythematosus

Fate Therapeutics Reports First Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "The Company’s ongoing multi-center, Phase 1 clinical trial of FT819 for moderate-to-severe systemic lupus erythematosus (SLE) (NCT06308978) is designed to evaluate the safety, pharmacokinetics, and efficacy of a single dose of FT819 following a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone. The Company is currently enrolling patients at two dose levels....The Company plans to present new clinical data from its FT819 Phase 1 study during an oral session at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona, Spain on June 11."

P1 data • Trial status • Systemic Lupus Erythematosus

Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE) (GlobeNewswire) - "Fate Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819, an investigational, off-the-shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the treatment of active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis (LN)....The Company’s RMAT application included initial clinical safety and activity data from patients treated with FT819 in its ongoing multi-center Phase 1 clinical trial....The Company will report additional clinical data from the Phase 1 study of FT819 at scientific meetings later in 2025."

FDA event • P1 data • Lupus Nephritis • Systemic Lupus Erythematosus

FT819-102: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease (clinicaltrials.gov) - P1 | N=244 | Recruiting | Sponsor: Fate Therapeutics | N=64 ➔ 244

Enrollment change • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Completed Type D Meeting with FDA for Inclusion of Additional Diseases in FT819 Phase 1 Study (GlobeNewswire) - "In December 2024, the Company reached an agreement with the U.S. Food and Drug Administration (FDA) to allow for the clinical investigation of additional B cell-mediated autoimmune diseases under our current Phase 1 clinical trial of FT819. As a follow-up to the meeting, the Company has submitted an amended clinical protocol to the FDA that enables the conduct of independent dose-expansion cohorts for SLE as well as anti-neutrophilic cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The Company plans to initiate dose-expansion cohorts in one or more of AAV, IIM, and SSc in 2025. Additionally, the FDA agreed to allow for investigation of a multi-dose treatment cycle as well as for re-treatment upon disease progression, making the treatment dosing paradigm more aligned with traditional biological therapies. The FDA also permitted the expansion of study eligibility criteria..."

Clinical protocol • FDA event • Trial status • ANCA Vasculitis • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis

Fate Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates (GlobeNewswire) - "Phase 1 Dose Expansion Initiated for SLE using Flu-free Conditioning Regimen: Based on clinical data from the first three patients treated with FT819 in its ongoing multi-center, Phase 1 clinical trial for moderate-to-severe systemic lupus erythematosus (SLE) (NCT06308978), the Company has initiated dose expansion in up to 10 patients at 360 million cells....First Patient Treated with FT819 as Add-on to Maintenance Therapy: The Company amended the clinical protocol of its FT819 Phase 1 study to include a new treatment arm to assess the safety, pharmacokinetics, and anti-B cell activity of a single dose of FT819 as an add-on to maintenance therapy without conditioning chemotherapy in patients with SLE. The first patient in the new arm was on a stable dose of oral mycophenolate mofetil (MMF) and was treated with a single dose of FT819 at 360 million cells without administration of any conditioning chemotherapy."

Trial status • Systemic Lupus Erythematosus

FT819 Patient 1 Case Study (GlobeNewswire) - P1 | N=64 | NCT06308978 | Sponsor: Fate Therapeutics | "Rapid elimination of CD19+ B cells in the periphery was observed following treatment, and B-cell recovery by Month 3 was predominantly comprised of naïve, non-class switched B cells with near-complete elimination of switched memory B cells and deep depletion of plasmablasts, indicative of an immune reset. The patient reported that her debilitating fatigue had entirely resolved without further treatment, and treatment with methylprednisolone was discontinued at Month 3. The patient achieved DORIS (definition of remission in SLE) clinical remission, including with resolution of arthritis and active urinary sediment and with a substantial reduction in proteinuria, as of Month 6 follow-up. The patient continues on-study, in DORIS clinical remission, and remains free of all immunosuppressive therapy."

P1 data • Immunology • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus

Fate Therapeutics Presents New Phase 1 Clinical Data of FT819 Off-the-shelf, CAR T-cell Product Candidate for Systemic Lupus Erythematosus (GlobeNewswire) - P1 | N=64 | NCT06308978 | Sponsor: Fate Therapeutics | "Fate Therapeutics, Inc...today presented new clinical and translational data from the Company’s FT819 Phase 1 Autoimmunity study for moderate-to-severe systemic lupus erythematosus (SLE) at the American Society of Hematology (ASH) Annual Meeting being held in San Diego, CA. The first three study patients, each of whom presented with active lupus nephritis (LN) despite having been treated with multiple standard-of-care therapies, received fludarabine-free conditioning followed by a single dose of FT819 at 360 million cells."

P1 data • Immunology • Lupus Nephritis • Systemic Lupus Erythematosus

Fate Therapeutics Reports Third Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - "Initial Clinical Data from Phase 1 Autoimmunity Study of FT819 1XX CAR T-cell Product Candidate to be Presented in 4Q24; Second Treatment Arm Adding FT819 to Maintenance Therapy without Conditioning Chemotherapy Opened for Enrollment; FT522 Multi-indication IND Application for Conditioning-free Treatment of B Cell-mediated Autoimmune Diseases Allowed by FDA; Initial Phase 1 Clinical Data in B-cell Lymphoma to be Presented at ACR Convergence."

IND • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immunology • Lupus • Lymphoma • Oncology • Systemic Lupus Erythematosus

Fate Therapeutics Presents 6-Month Follow-up Data on First Patient Treated in Phase 1 Autoimmunity Study with Fludarabine-free Conditioning and FT819 Off-the-shelf, 1XX CAR T-cell Product Candidate at ACR Convergence (GlobeNewswire) - P1 | N=64 | NCT06308978 | Sponsor: Fate Therapeutics | "Fate Therapeutics...today presented initial clinical and translational data from the first patient treated in its FT819 Phase 1 Autoimmunity study for moderate-to-severe systemic lupus erythematosus (SLE) at the American College of Rheumatology (ACR) Convergence being held in Washington, D.C....The patient achieved DORIS (definition of remission in SLE) clinical remission and LLDAS (low lupus disease activity state) as of Month 6 follow-up. The patient continues on-study, in clinical remission, and free of all immunosuppressive therapies as of a data cutoff date of November 11, 2024.... The Company plans to present clinical and translational data from the first three patients at the American Society of Hematology (ASH) Annual Meeting being held in San Diego, CA on December 7-10."

P1 data • Immunology • Systemic Lupus Erythematosus

Fate Therapeutics Reports Second Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - P1 | N=64 | NCT06308978 | Sponsor: Fate Therapeutics | "The first patient treated in the study, a 27 year-old woman diagnosed with lupus nephritis over ten years ago who has refractory disease despite having been treated with multiple standard-of-care therapies, received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells. The patient remains on-study, and there have been no Grade ≥3 adverse events and no events of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD). The Company plans to present clinical and translational data from the Phase 1 study at a medical conference in the second half of 2024....The Company intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter of 2024 for the treatment of a basket of B cell-mediated autoimmune diseases with FT522..."

IND • P1 data • Immunology • Lupus • Systemic Lupus Erythematosus

FT819 in Moderate to Severe Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Fate Therapeutics | N=32 ➔ 64

Enrollment change • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Fate Therapeutics | Recruiting ➔ Active, not recruiting | N=396 ➔ 54

Enrollment change • Enrollment closed • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD19 • IL2

Fate Therapeutics Announces First Lupus Patient Treated in Phase 1 Autoimmunity Study of Off-the-shelf FT819 CAR T-cell Program (GlobeNewswire) - "Fate Therapeutics, Inc...announced that the first patient with systemic lupus erythematosus (SLE) has been treated in the Phase 1 autoimmunity study of FT819...The multi-center, Phase 1 autoimmunity study of FT819 is designed to assess safety, pharmacokinetics, and anti-B cell activity for patients with moderate-to-severe SLE (NCT06308978). The first patient, a 27 year-old woman diagnosed with SLE over ten years ago who has refractory disease despite having been treated with multiple standard-of-care therapies, received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells."

Trial status • Immunology • Lupus • Systemic Lupus Erythematosus

Fate Therapeutics Announces First Lupus Patient Treated in Phase 1 Autoimmunity Study of Off-the-shelf FT819 CAR T-cell Program (GlobeNewswire) - P1 | N=396 | NCT04629729 | Sponsor: Fate Therapeutics | "Translational data presented today at ASGCT from the Company’s Phase 1 BCM study show that a single dose of FT819 exhibited multiple therapeutic mechanisms implicated in generating an immune reset in patients with B cell-mediated autoimmune disease. Clinical data highlighted today at ASGCT include: Blood samples taken from 23 patients treated for relapsed / refractory B cell lymphoma showed rapid and deep CD19+ B cell depletion, with sustained suppression of B cells, in the periphery during the initial 30-day period following administration of standard conditioning chemotherapy and FT819."

P1 data • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Fate Therapeutics Announces Presentation of FT819 Proof-of-Concept Data for B cell-mediated Autoimmune Diseases at ASGCT Annual Meeting (GlobeNewswire) - "Fate Therapeutics...announced that two presentations will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting....The Company will present data of key therapeutic mechanisms of activity for autoimmune diseases, including B cell depletion, tissue infiltration and immune reconstitution, from its Phase 1 study of FT819 in relapsed / refractory B-cell malignancies....In addition, the Company will highlight preclinical data from its off-the-shelf, iPSC-derived, CAR T-cell product platform for solid tumors, with an oral presentation of a novel MICA/B-targeted CAR T-cell product candidate that is designed to target a broad array of tumor types and to overcome immune cell evasion by shedding of stress ligands."

P1 data • Preclinical • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Lymphoma

FT819-102: Clinical Translation of Off-the-Shelf TCR-Less CD8ab+ Anti-CD19 CAR-T Cells for the Treatment of B Cell-Mediated Autoimmune Disorders (ASGCT 2024) - P1 | "Rituximab, an anti-CD20 antibody, has demonstrated the ability to deplete peripheral blood B cells. Recovery of B cells in the periphery occurred 1-3 months after the treatment cycle. Based on itsestablished clinical and translational profile in B-cell lymphoma, coupled withpreclinical data in CD19-mediated autoimmunity, FT819 may be an idealoff-the-shelf cell therapy with the potential to reset the immune system ofpatients with autoimmune diseases."

CAR T-Cell Therapy • Clinical • Fibrosis • Glomerulonephritis • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

FT819 in Moderate to Severe Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Fate Therapeutics

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Fate Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates (GlobeNewswire) - "FT819 iPSC-derived CAR T-cell Program: CLIN2 Grant Awarded by CIRM to Fund FT819 Phase 1 Autoimmunity Study in SLE. In February, the Company was awarded $7.9 million by the California Institute for Regenerative Medicine (CIRM) to support clinical investigation of FT819 in patients with systemic lupus erythematosus (SLE)....The Company is currently conducting study start-up activities at multiple U.S. clinical sites....Preclinical Studies Ongoing to Support Expansion into Autoimmunity. The Company is conducting a preclinical assessment of the potential for FT522 to induce CD19+ B-cell depletion across a range of autoimmune diseases, including without administration of intense chemotherapy conditioning to patients."

Financing • Preclinical • Immunology • Systemic Lupus Erythematosus

Fate Therapeutics Reports Second Quarter 2023 Financial Results and Business Updates (GlobeNewswire) - "The Company’s landmark Phase 1 clinical trial of FT819 is the first-ever clinical investigation of a T-cell product candidate manufactured from a clonal master iPSC line....The Company is currently enrolling patients in single-dose treatment cohorts at 540 million cells in B-cell lymphoma and at 360 million cells in chronic lymphocytic leukemia....The Company is currently conducting IND-enabling activities and GMP manufacturing of FT825/ONO-8250, and plans to submit an IND application to the FDA in the second half of 2023 to jointly conduct a Phase 1 study for the treatment of patients with HER2-positive solid tumors."

Enrollment status • IND • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov) - P1 | N=396 | Recruiting | Sponsor: Fate Therapeutics | N=297 ➔ 396

Enrollment change • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • IL2

Clinical Manufacture of FT819: Use of a Clonal Multiplexed-Engineered Master Induced Pluripotent Stem Cell Line to Mass Produce Off-the-Shelf CAR T-Cell Therapy (ASH 2021) - P1 | "A multi-center Phase 1 study of FT819 is currently ongoing for the treatment of B-cell malignancies. Key Words: cancer immunotherapy, cell therapy, CAR-T, CD19, allogeneic, induced pluripotent stem cell, iPSC, clonal master iPSC line, engineered, off-the-shelf, cGMP, production, manufacturing, FT819"

CAR T-Cell Therapy • IO biomarker • Preclinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD34 • CD7 • PTPRC

Interim Phase I Clinical Data of FT819-101, a Study of the First-Ever, Off-the-Shelf, iPSC‑Derived TCR‑Less CD19 CAR T‑Cell Therapy for Patients with Relapsed/Refractory B‑Cell Malignancies (ASH 2022) - "Conditioning chemotherapy consists of 3 consecutive days of fludarabine (30 mg/m2) and cyclophosphamide (500 mg/m2) prior to the first dose of FT819. FT819 is the first-ever, off-the-shelf, iPSC-derived CAR T-cell therapy to be tested in clinical trials. The ongoing Phase I study is designed to assess multiple dosing regimens across a broad range of B-cell malignancies. Interim clinical data, including safety, tolerability, and initial anti-tumor activity from the ongoing Phase I dose-escalation study of FT819, will be presented at the conference."

CAR T-Cell Therapy • Clinical data • IO biomarker • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • IL2