Drugs / FT819
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06308978 | Mar 2024 → Sep 2027 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis, idiopathic inflammatory myopathy, lupus nephritis, systemic lupus erythematosus +1 | Fate Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT04629729 | Jul 2021 → Jun 2025 overdue | B-cell chronic lymphocytic leukemia, precursor B-cell acute lymphoblastic leukemia | Fate Therapeutics | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07570862 | Jul 2026 → Jul 2029 expected | lupus nephritis, systemic lupus erythematosus | Fate Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-09-09 | Fate Therapeutics | Results Fate Therapeutics Announces Encore Clinical Data Presentation of FT819 Off-the-Shelf CAR T-Cell Product Candidate at the CCR – West 2026 Meeting fatetherapeutics.com ↗
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. |
| 2026-07-06 | Fate Therapeutics | Results 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 fatetherapeutics.com ↗
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. |
| 2026-06-04 | Fate Therapeutics | Results Fate Therapeutics Showcases Data from FT819 and FT839 Programs at the European Congress of Rheumatology Annual Meeting fatetherapeutics.com ↗
Continued demonstration of rapid and sustained clinical improvement with favorable tolerability profile observed following treatment of systemic lupus erythematosus (SLE) patients with FT819 and less-intensive conditioning chemotherapy |
| 2026-05-11 | Fate Therapeutics | Results Fate Therapeutics Showcases FT819 Clinical Activity in SLE without the use of Conditioning Chemotherapy at the 2026 ASGCT Annual Meeting fatetherapeutics.com ↗
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 |
| 2026-05-05 | Fate Therapeutics | Regulatory Fate Therapeutics Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of FT819 fatetherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has selected FT819 for participation in the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program for treatment of moderate to severe systemic lupus erythematosus (SLE). |
| 2026-05-04 | Fate Therapeutics | Results Fate Therapeutics Announces Three Presentations at the 2026 ASGCT Annual Meeting Highlighting Off-the-Shelf CAR T-cell Therapy Pipeline for Cancer and Autoimmune Diseases fatetherapeutics.com ↗
FT819 Drives B cell Compartment Remodeling of Patients with Systemic Lupus Erythematosus Without Conditioning Chemotherapy |
| 2026-04-30 | Fate Therapeutics | Results 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 fatetherapeutics.com ↗
The presentation includes clinical safety, efficacy and translational data from 13 SLE patients with a data cutoff of December 23, 2025 . |
| 2025-12-08 | Fate Therapeutics | Results Fate Therapeutics Presents Updated Phase 1 Clinical Data of FT819 Off-the-shelf CAR T-cell Product Candidate for Systemic Lupus Erythematosus and Preclinical Advances in Next-Generation Off-the-Shelf CAR T-cell Programs fatetherapeutics.com ↗
The updated results demonstrate sustained clinical responses, durable B-cell depletion in a potential dose-response manner, and a differentiated safety profile without the need for intensive-conditioning chemotherapy that typically consists of multiple days of combined doses of cyclophosphamide and fludarabine. |
| 2025-11-13 | Fate Therapeutics | Regulatory Fate Therapeutics Reports Third Quarter 2025 Financial Results and Business Updates fatetherapeutics.com ↗
Authorization Received from UK and EU Authorities to Activate ex-US Clinical Trial Sites Supporting the Ongoing Patient Enrollment of FT819, an Off-the-Shelf CD19-targeted CAR T-cell Product Candidate that Utilizes Less-intensive or No Conditioning, Enabling Broad Patient Accessibility |
| 2025-10-26 | Fate Therapeutics | Results Fate Therapeutics Presents New Clinical Data at ACR Convergence 2025 Demonstrating Immune Remodeling and Durable Responses in Patients with Systemic Lupus Erythematosus Treated with FT819 Off-the-Shelf CAR T-Cell Therapy fatetherapeutics.com ↗
All patients surpassing a 3-month post-treatment time point (n=5) showed significant reductions in the SLE Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA) |
| 2025-08-12 | Fate Therapeutics | Results Fate Therapeutics Reports Second Quarter 2025 Financial Results and Business Updates fatetherapeutics.com ↗
First patient treated with FT819 off-the-shelf CAR T-cell product candidate following fludarabine-free conditioning for severe lupus nephritis demonstrated durability of response with drug-free definition of remission in systemic lupus erythematosus (DORIS) at 12-month follow-up |
| 2025-06-11 | Fate Therapeutics | Results 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 fatetherapeutics.com ↗
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) |
| 2025-05-13 | Fate Therapeutics | Regulatory Fate Therapeutics Reports First Quarter 2025 Financial Results and Business Updates fatetherapeutics.com ↗
Regenerative Medicine Advanced Therapy Designation Granted by the FDA for FT819 in Moderate-to-Severe Systemic Lupus Erythematosus |
| 2025-04-14 | Fate Therapeutics | Regulatory Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE) fatetherapeutics.com ↗ |
| 2024-12-09 | Fate Therapeutics | Results Fate Therapeutics Presents New Phase 1 Clinical Data of FT819 Off-the-shelf, CAR T-cell Product Candidate for Systemic Lupus Erythematosus fatetherapeutics.com ↗
In all three patients, FT819 was detected in the peripheral blood and rapid, deep, and sustained elimination of CD19+ B cells in the periphery was observed during the first month of treatment. |
| 2024-11-18 | Fate Therapeutics | Results 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 fatetherapeutics.com ↗
The patient achieved DORIS (definition of remission in SLE) clinical remission and LLDAS (low lupus disease activity state) as of Month 6 follow-up. |
| 2024-11-12 | Fate Therapeutics | Results Fate Therapeutics Reports Third Quarter 2024 Financial Results and Business Updates fatetherapeutics.com ↗
All three patients remain on-study, and there have been no dose-limiting toxicities (DLTs) and no events of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD). |
| 2023-11-08 | Fate Therapeutics | Regulatory Fate Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates fatetherapeutics.com ↗
IND Application Cleared by FDA for FT819 CD19-targeted 1XX CAR T-cell Program for Systemic Lupus Erythematosus |
| 2022-12-10 | Fate Therapeutics | Results Fate Therapeutics Announces Clinical Safety and Activity Data of First-ever iPSC-derived CAR T-cell Therapy at 2022 ASH Annual Meeting fatetherapeutics.com ↗
Interim Phase 1 Dose-escalation Data Indicate Favorable Safety Profile with Complete Responses in Heavily Pre-treated Patients with Aggressive Large B-cell Lymphoma |
| 2022-08-09 | Fate Therapeutics | Results Fate Therapeutics Announces Preclinical Publication Highlighting Derivation of CD8αβ T Cells from TCR-CAR+ Induced Pluripotent Stem Cells fatetherapeutics.com ↗
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today announced the publication of preclinical study results demonstrating the successful generation, durable anti-tumor response, and functional persistence of TCR - CAR + iPSC-derived CD8αβ T cells from induced pluripotent stem cells (iPSCs). |
| 2020-07-09 | Fate Therapeutics | Regulatory Fate Therapeutics Announces FDA Clearance of IND Application for First-ever iPSC-derived CAR T-Cell Therapy fatetherapeutics.com ↗ |
| 2019-12-10 | Fate Therapeutics | Results Fate Therapeutics Presents its First Off-the-shelf, iPSC-derived CAR T-Cell Cancer Immunotherapy Program at ASH Annual Meeting fatetherapeutics.com ↗
At ASH, scientists from the Company and MSK presented new in vivo preclinical data demonstrating that FT819 exhibits durable tumor control and extended survival. |
| 2019-04-01 | Fate Therapeutics | Results Fate Therapeutics Presents Late-Breaking Preclinical Data Highlighting Unique Advantages of Clonal Master Engineered iPSC Lines for Off-the-Shelf CAR T-cell Therapy at 2019 AACR Annual Meeting fatetherapeutics.com ↗
FT819 Off-the-Shelf CAR19 T-cell Product Candidate Demonstrates Complete Elimination of TCR Expression and Integration of Novel 1XX CAR into TRAC Locus |
| 2018-04-16 | Fate Therapeutics | Results Fate Therapeutics Announces Off-the-Shelf CAR T-cell Cancer Immunotherapy to be Featured at 2018 AACR Annual Meeting Press Program fatetherapeutics.com ↗
The product candidate’s activity was also found to be target-specific in vitro , attacking only CD19-positive tumor cells and sparing CD19-negative tumor cells. |
All press releases naming this drug 29 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FT819 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06308978 ↗ |
| Modality | Cell therapy | “allogeneic T cells derived from a clonal, TCR knockout iPSC line” NCT07570862 ↗ |
| Route | Intravenous | “FT819 will be administered as intravenous (IV) infusion at planned dose levels.” NCT06308978 ↗ |
| Target | CD19 | “express CD19-targeted CAR regulated by the TRAC locus” NCT07570862 ↗ |