This section highlights FDA-related milestones and regulatory updates for drugs developed by Fate Therapeutics (FATE).
Over the past two years, Fate Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FT522 and FT819. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FT522 - FDA Regulatory Timeline and Events
FT522 is a drug developed by Fate Therapeutics for the following indication: In relapsed / refractory B-cell lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FT522
- Announced Date:
- November 18, 2024
- Indication:
- In relapsed / refractory B-cell lymphoma
Announcement
Fate Therapeutics, Inc. today presented initial clinical and translational data from the Company's Phase 1 study of FT522 in relapsed / refractory B-cell lymphoma at the American College of Rheumatology (ACR) Convergence being held in Washington, D.C.
AI Summary
Fate Therapeutics, Inc. recently presented early clinical and translational data from its Phase 1 study of FT522 at the American College of Rheumatology (ACR) Convergence in Washington, D.C. The study is focused on relapsed or refractory B-cell lymphoma, a patient group in need of innovative treatments. Initial findings highlight promising activity of FT522, an off-the-shelf CAR T-cell therapy, showing potential in reducing tumor cell populations while maintaining an acceptable safety profile. Researchers noted that the therapy demonstrated significant anti-cancer effects, with key insights into its mechanism emerging from the translational data. These preliminary results suggest that FT522 may offer a new treatment option for patients who have not benefited from standard therapies. Further studies are planned to confirm these early observations and explore long-term outcomes for patients with challenging B-cell lymphomas.
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FT819 - FDA Regulatory Timeline and Events
FT819 is a drug developed by Fate Therapeutics for the following indication: Advanced B-cell Leukemias and Lymphomas.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FT819
- Announced Date:
- June 11, 2025
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc. announced new and updated clinical data from the first five patients dosed with FT819 for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona, Spain.
AI Summary
Fate Therapeutics announced new and updated clinical data at the EULAR 2025 Congress in Barcelona for its FT819 therapy for moderate-to-severe systemic lupus erythematosus (SLE). In this early Phase 1 study, the first five patients treated showed promising results. Three patients with active lupus nephritis who received a fludarabine-free conditioning regimen achieved a primary efficacy renal response (PERR), with one patient maintaining drug‐free remission at a 12-month follow-up. Additionally, an extra-renal lupus patient on standard maintenance therapy and treated without conditioning reached a low lupus disease activity state (LLDAS) at 3 months, which was sustained through 6 months. The initial clinical findings suggest that FT819, as an off-the-shelf CAR T-cell product, may offer effective disease control with a favorable safety profile, minimal hospitalization, and reduced or no conditioning chemotherapy.
Read Announcement- Drug:
- FT819
- Announced Date:
- May 28, 2025
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc. announced that clinical and preclinical data from the Company's off-the-shelf cell therapy product platform will be featured at the European Alliance of Associations for Rheumatology European Congress of Rheumatology (EULAR 2025), being held in Barcelona, Spain on June 11-14, 2025.
AI Summary
Fate Therapeutics, Inc. announced that clinical and preclinical data from its off-the-shelf cell therapy product platform will be presented at the European Alliance of Associations for Rheumatology European Congress of Rheumatology (EULAR 2025) in Barcelona, Spain, from June 11-14, 2025. This presentation will highlight data from the Phase 1 clinical trial of FT819, a CD19-targeted CAR T-cell therapy aimed at treating moderate-to-severe systemic lupus erythematosus without the need for traditional conditioning chemotherapy.
The company will also share preclinical and translational findings from its iPSC-derived platform, which includes both CAR T-cell and CAR-NK cell products. These insights focus on new strategies like Sword and Shield technology and multi-antigen targeting, which could enhance therapeutic outcomes and enable outpatient treatment. This event underscores Fate Therapeutics’ dedication to advancing innovative cell therapies for autoimmune diseases.
Read Announcement- Drug:
- FT819
- Announced Date:
- April 14, 2025
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
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).
AI Summary
Fate Therapeutics, Inc. announced that the U.S. FDA granted RMAT designation to FT819, an investigational, off-the-shelf CAR T-cell therapy derived from induced pluripotent stem cells. FT819 is currently in a Phase 1 clinical trial aimed at treating active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis. The RMAT designation underscores the therapy’s potential to address a significant unmet need in lupus treatment while allowing more frequent interactions with the FDA during its development. FT819 is designed to offer a cost-effective, on-demand treatment option that could reduce the need for intensive chemotherapy and long hospital stays. Initial clinical safety and activity data from the ongoing trial supported the RMAT designation, and additional Phase 1 data is planned to be presented at medical conferences in 2025.
Read Announcement- Drug:
- FT819
- Announced Date:
- April 14, 2025
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc Additional Phase 1 clinical data of FT819 to be presented at medical conferences in 2025
AI Summary
Fate Therapeutics is set to share additional Phase 1 clinical data on its FT819 product at medical conferences in 2025. FT819 is an off-the-shelf CAR T-cell therapy being developed as a treatment for active, moderate to severe systemic lupus erythematosus (SLE). The ongoing Phase 1 trial is testing a new approach that uses a fludarabine-free conditioning regimen followed by a single dose of FT819. The study includes expanding the treatment dose in up to 10 patients and assessing safety and effectiveness at higher doses. By presenting updated findings next year, Fate Therapeutics aims to provide more insight into the therapy’s safety profile and its potential to meet an urgent need for lupus patients. This step is significant as it shows the company’s commitment to developing innovative, on-demand treatments that may eventually be used in community settings to help patients in underserved areas.
Read Announcement- Drug:
- FT819
- Announced Date:
- March 5, 2025
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc. today reported business highlights
AI Summary
Fate Therapeutics, Inc. reported key business highlights for its FT819 off-the-shelf CAR T-cell treatment in patients with moderate-to-severe systemic lupus erythematosus (SLE). The company has begun a Phase 1 dose expansion study using a fludarabine-free conditioning regimen. In addition, a new treatment arm was added to assess FT819 as an add-on to maintenance therapy without the need for conditioning chemotherapy. The first patient in this arm was successfully treated without any dose-limiting toxicities. Additionally, Fate Therapeutics recently completed a Type D meeting with the FDA, which approved an amended clinical protocol. This update allows the company to explore FT819 in additional B cell-mediated autoimmune diseases. These steps mark an important advancement in the development of the company’s CAR T-cell therapies, with more clinical and regulatory updates expected throughout the year.
Read Announcement- Drug:
- FT819
- Announced Date:
- December 9, 2024
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc 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.
AI Summary
Fate Therapeutics, Inc. recently presented new clinical and translational data from its FT819 Phase 1 Autoimmunity study for moderate‐to‐severe systemic lupus erythematosus (SLE) at the American Society of Hematology Annual Meeting in San Diego, CA. In this early trial, three patients with active lupus nephritis, who had not responded to multiple standard treatments, received fludarabine-free conditioning followed by a single dose of 360 million FT819 cells.
The treatment led to rapid, deep, and sustained elimination of CD19+ B cells while maintaining a favorable safety profile—no dose-limiting toxicities, cytokine release syndrome, neurotoxicity, or graft-versus-host disease were observed. Notably, the first patient has maintained drug-free clinical remission for six months. Encouraged by these positive results, Fate Therapeutics is now initiating a dose expansion at this initial dose level, highlighting the potential of FT819 as a transformative off-the-shelf CAR T-cell therapy for SLE.
Read Announcement- Drug:
- FT819
- Announced Date:
- November 18, 2024
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
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.
AI Summary
Fate Therapeutics presented promising 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 in Washington, D.C. The patient, a 27-year-old African American-Asian woman with lupus nephritis, received a single dose of FT819 after fludarabine-free conditioning. By six months, she achieved DORIS clinical remission, with notable improvements including the resolution of fatigue and arthritis, along with normalized urinary findings. Importantly, she remains on-study and off all immunosuppressive therapies, with no severe adverse events reported, such as cytokine release syndrome or neurotoxicity. These encouraging results suggest that FT819 may offer a safer, off-the-shelf CAR T-cell therapy option that possibly changes how severe lupus cases are treated.
Read Announcement
