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
FT819, FT839, and FT522. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- May 5, 2026
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc. 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).
AI Summary
Fate Therapeutics announced that the U.S. Food and Drug Administration has selected its investigational therapy FT819 for the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The selection covers FT819’s planned use to treat moderate-to-severe systemic lupus erythematosus (SLE).
The CDRP program is designed to speed up manufacturing readiness for therapies on fast clinical tracks. Participation can help Fate refine production processes and meet regulatory expectations more quickly. Fate says CDRP involvement could support advancement of FT819’s Phase 2, potentially registrational clinical trial in patients with refractory moderate-to-severe SLE, including those with lupus nephritis, by helping align manufacturing and development steps with regulatory needs.Read Announcement
- Drug:
- FT819
- Announced Date:
- May 4, 2026
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics will present clinical and translational data from the systemic lupus erythematosus (SLE) arm of its ongoing Phase 1 trial evaluating FT819 in Regimen B, where FT819 is added to background maintenance therapy without the use of conditioning chemotherapy to drive B cell depletion and improve patient outcome.
AI Summary
Fate Therapeutics will present clinical and translational data from the systemic lupus erythematosus (SLE) arm of its ongoing Phase 1 trial evaluating FT819 in Regimen B. In this approach, FT819 is added to patients’ existing maintenance therapy without using conditioning chemotherapy. The company will share findings under the poster titled “FT819 Drives B cell Compartment Remodeling of Patients with Systemic Lupus Erythematosus Without Conditioning Chemotherapy,” presented at a poster reception on Tuesday, May 12, 5:00–6:30 PM ET.
The data are expected to describe how FT819 affects B cell populations and related biomarkers, along with early safety and clinical signals. Because no conditioning chemotherapy is used, emphasis will be on whether FT819 can deplete or remodel pathogenic B cells while remaining tolerable on top of standard therapy. Positive results could suggest a less toxic CAR T approach for autoimmune disease that improves outcomes without intensive preparative regimens.Read Announcement
- Drug:
- FT819
- Announced Date:
- April 30, 2026
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc. announced that clinical data from the Company's off-the-shelf CAR T-cell product candidate, FT819, will be featured at the Congress of Clinical Rheumatology – East meeting, being held in Destin, FL on April 30 - May 3, 2026.
AI Summary
Fate Therapeutics announced that clinical data from its off-the-shelf CAR T-cell candidate FT819 will be featured at the Congress of Clinical Rheumatology – East meeting in Destin, FL, April 30–May 3, 2026. The company is taking part in a Poster Rounding Session and will present an encore of data from the systemic lupus erythematosus (SLE) arm of its ongoing Phase 1 trial evaluating FT819 in autoimmune diseases. The poster is titled “Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy with Reduced Conditioning in SLE: A Phase 1 Study.”
The presentation will include clinical safety, efficacy, and translational data from 13 SLE patients, with a data cutoff of December 23, 2025. The session is the CCR-East Faculty Poster Rounding Session, scheduled for Friday, May 1, 2026, from 2:55 p.m. to 6:00 p.m. EDT. Attendees can review the detailed results during the poster session.
Read Announcement- Drug:
- FT819
- Announced Date:
- December 8, 2025
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc. presented updated clinical data from its ongoing Phase 1 trial evaluating its FT819 off-the-shelf iPSC-derived CAR T-cell program in systemic lupus erythematosus (SLE) and unveiled new preclinical data from next-generation off-the-shelf iPSC-derived CAR T-cell programs for hematologic malignancies and autoimmune diseases at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida.
Read Announcement- Drug:
- FT819
- Announced Date:
- October 26, 2025
- Indication:
- Advanced B-cell Leukemias and Lymphomas
Announcement
Fate Therapeutics, Inc. announced new and updated data from the first 10 patients dosed with FT819 in a Phase 1 clinical trial for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) at the American College of Rheumatology (ACR) Convergence 2025 in Chicago.
AI Summary
Fate Therapeutics announced new results from the first 10 patients treated with FT819, their off-the-shelf CAR T-cell therapy, in a Phase 1 trial for moderate-to-severe systemic lupus erythematosus presented at ACR Convergence 2025.
Patients received a single dose with either less-intensive or no conditioning chemotherapy. FT819 showed a favorable safety profile with no dose-limiting toxicities, enabling same-day discharge. Among five patients with over three months of follow-up, all experienced meaningful drops in SLE Disease Activity Index (SLEDAI-2K) and Physician’s Global Assessment scores.
Two patients with lupus nephritis achieved complete renal response at six months, and one remains in drug-free remission at 15 months. Translational data demonstrated rapid CD19+ B cell depletion and immune remodeling toward a naïve B-cell repertoire.
These findings support FT819’s potential for broad accessibility and durable benefit in SLE and other autoimmune diseases.
Under its RMAT designation, Fate is engaging regulators on a registrational study design with plans to initiate a pivotal trial next year.
Read Announcement- 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
FT839 FDA Regulatory Events
FT839 is a drug developed by Fate Therapeutics for the following indication: Treatment of Hematological Malignancies and Autoimmune Diseases Without the Need for Conditioning Chemotherapy.
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:
- FT839
- Announced Date:
- April 16, 2026
- Indication:
- Treatment of Hematological Malignancies and Autoimmune Diseases Without the Need for Conditioning Chemotherapy
Announcement
Fate Therapeutics, Inc. announced that preclinical data from the Company's next-generation, off-the-shelf CAR T-cell product candidate, FT839, will be featured at the American Association for Cancer Research Annual Meeting, being held in San Diego, CA on April 17-22, 2026.
AI Summary
Fate Therapeutics announced that preclinical data for its next-generation, off-the-shelf CAR T-cell candidate, FT839, will be featured at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, April 17–22, 2026. The data will be presented as a poster titled “FT839: A next-generation, off-the-shelf CAR T-cell uniquely engineered with a dual CAR system targeting CD19 and CD38 for the treatment of hematological malignancies and autoimmune diseases without conditioning chemotherapy.” The poster appears in the CAR T-Cell Functional Enhancement session on Tuesday, April 21, 2026, from 9:00 a.m. to Noon PDT. An abstract and poster details are available through the conference listings.
FT839 is described as an off-the-shelf, dual-CAR T-cell product engineered to target both CD19 and CD38. Fate says the design aims to treat blood cancers and certain autoimmune diseases while potentially avoiding the need for conditioning chemotherapy, which could shorten time to treatment and reduce side effects. The presentation will report the company’s preclinical findings supporting this approach.
Read Announcement
FT522 FDA Regulatory 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.
Read Announcement
