FT819 anti-CD19 CAR T-cell therapy for autoimmune disease
phase 2drug program · high · Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate an off-the-shelf allogeneic iPSC-derived CD19-targeted CAR T-cell therapy for B-cell-mediated autoimmune diseases including systemic lupus erythematosus, lupus nephritis, ANCA-associated vasculitis, idiopathic inflammatory myositis, and systemic sclerosis.
Clinical studies of FT819, allogeneic T cells expressing a CD19-targeted CAR, administered with or without conditioning or auxiliary medicinal product; Phase 2 lupus nephritis trial evaluates complete renal response at Week 26 after bendamustine.
Phase 2 open-label single-arm trial in refractory moderate-to-severe lupus nephritis listed with a 2026-07-01 public record; Phase 1 autoimmune study and 2026 EULAR SLE poster also reported.
A 2026 EULAR poster reports safety and efficacy of off-the-shelf anti-CD19 CAR T-cell therapy with reduced conditioning in SLE, supporting same-day discharge; detailed numeric results were not supplied.
FT836 MICA/B-targeted CAR T-cell therapy for advanced solid tumors
phase 1drug program · high · Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
Treat advanced solid tumors by targeting MICA/B and overcoming solid tumor escape mechanisms while avoiding the requirement for conditioning chemotherapy.
Phase 1 study of FT836 administered with or without paclitaxel and/or trastuzumab or cetuximab; evaluates safety, tolerability, and recommended Phase 2 dose in combination regimens.
Phase 1 advanced solid tumor trial listed with a 2025-11-04 public record; 2026 ASCO poster reported preliminary Phase 1 results.
The supplied ASCO poster title states preliminary Phase 1 results for a MICA/B-targeted CAR T cell designed to overcome solid tumor escape mechanisms and avoid conditioning chemotherapy; detailed numeric outcomes were not supplied.
FT825/ONO-8250 HER2 CAR T-cell therapy for advanced solid tumors
phase 1drug program · high · Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate an off-the-shelf HER2-directed CAR T-cell therapy for HER2-positive or other advanced solid tumors, with or without monoclonal antibody therapy.
Phase 1 dose-escalation and expansion study following chemotherapy; iPSC-derived HER2 CAR T cells engineered for solid tumor activity and optional combination with monoclonal antibodies.
Phase 1 clinical trial listed for FT825/ONO-8250 in advanced solid tumors.
2025 Cell Stem Cell abstract describes iPSC-derived HER2-directed CAR T cells with HER2-specific antitumor activity in vitro and in vivo, limited cytolytic targeting of HER2-positive normal targets, and engineering for persistence, TGF-beta resistance, and migration.
FT825 / ONO-8250 HER2 CAR T-cell therapy for advanced solid tumors
phase 1drug program · high · Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate an off-the-shelf HER2-directed CAR T-cell therapy, with or without monoclonal antibodies, for HER2-positive or other advanced solid tumors.
Phase 1 dose-escalation and expansion study of FT825/ONO-8250 following chemotherapy, with or without monoclonal antibody therapy, in indication-specific cohorts.
Phase 1 clinical trial listed with a 2024-01-05 public record.
A 2025 Cell Stem Cell publication describes iPSC-derived HER2-directed CAR T cells engineered to overcome multiple barriers to solid tumor efficacy, including HER2 targeting, antibody combination potential, IL-7R fusion, TGF-beta-IL-18R, and CXCR2 engineering.
FT522 CAR NK-cell therapy for B-cell lymphoma and systemic autoimmunity
phase 1drug program · high · Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Develop an off-the-shelf CAR NK-cell therapy able to target pathogenic cell types in B-cell lymphoma and systemic autoimmunity, including approaches that may circumvent lympho-conditioning.
Phase 1 study of FT522 with rituximab in relapsed/refractory B-cell lymphoma, assessed with or without conditioning chemotherapy; publication/presentation evidence also describes CAR NK targeting in systemic autoimmunity.
Phase 1 FT522-101 trial in relapsed/refractory B-cell lymphoma listed with a 2023-11-16 public record; 2024 presentation described FT522 in systemic autoimmunity.
The 2024 presentation title states FT522 is a CAR NK cell with ability to target multiple pathogenic cell types and circumvent lympho-conditioning in systemic autoimmunity; detailed results were not supplied.
FT522 CAR NK cell therapy for relapsed/refractory B-cell lymphoma
phase 1drug program · high · Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Treat relapsed/refractory B-cell lymphoma with an off-the-shelf CAR NK cell product in combination with rituximab, with or without conditioning chemotherapy.
Phase 1 study of FT522 plus rituximab, assessing safety, tolerability, and recommended phase 2 dose; CAR NK cell designed to target multiple pathogenic cell types and potentially circumvent lympho-conditioning in systemic autoimmunity.
Phase 1 FT522-101 clinical trial listed for relapsed/refractory B-cell lymphoma; 2024 publication/presentation title also describes FT522 in systemic autoimmunity.
FT596 CAR NK cell therapy with R-CHOP for B-cell lymphoma
phase 1drug program · high · Thu Dec 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate FT596 in combination with R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.
Phase 1 dose-escalation and dose-expansion clinical study using two R-CHOP schedules, standard or alternate.
Phase 1 clinical trial listed for FT596 plus R-CHOP in B-cell lymphoma.
FT596 CAR NK-cell therapy with R-CHOP for B-cell lymphoma
phase 1drug program · high · Thu Dec 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate FT596 in combination with R-CHOP for subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.
Phase 1 clinical study testing FT596 with two R-CHOP schedules, standard or alternate, with dose-escalation followed by dose-expansion.
Phase 1 trial public record dated 2022-12-01.
FT536 NK cell therapy for advanced solid tumors
phase 1drug program · high · Tue May 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate FT536 in advanced solid tumors, including use with monoclonal antibodies after lymphodepletion.
Phase 1 dose-finding study with dose-escalation and indication-specific expansion cohorts.
Phase 1 clinical trial listed for FT536 in combination with monoclonal antibodies in advanced solid tumors.
FT536 NK-cell therapy for advanced solid tumors
phase 1drug program · high · Tue May 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate FT536, alone or in combination with monoclonal antibodies, for advanced solid tumors.
Phase 1 dose-finding clinical study of FT536 in combination with a monoclonal antibody following lymphodepletion, with dose-escalation and indication-specific expansion cohorts.
Phase 1 trial public record dated 2022-05-31.
FT576 cell therapy for multiple myeloma
phase 1drug program · high · Wed Nov 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Treat multiple myeloma as monotherapy and in combination with daratumumab.
Phase 1 dose-finding study of FT576 alone and with the monoclonal antibody daratumumab, including dose-escalation and expansion stages.
Phase 1 clinical trial listed for FT576 in multiple myeloma.
FT576 cellular therapy for multiple myeloma
phase 1drug program · high · Wed Nov 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate FT576 as monotherapy and in combination with daratumumab for multiple myeloma.
Phase 1 dose-finding study of FT576 as monotherapy and with the monoclonal antibody daratumumab, including dose-escalation and expansion stages.
Phase 1 trial public record dated 2021-11-10.
Fate iPSC-derived off-the-shelf cellular immunotherapy platform
exploratoryplatform · high
Create renewable, programmed off-the-shelf cellular immunotherapies for cancer and autoimmune diseases using engineered human induced pluripotent stem cells.
Engineered clonal master iPSC lines are used for renewable cell manufacture of multiplexed-engineered T-cell and natural killer cell candidates.
Company pipeline lists multiple candidates derived from the platform, including FT819, FT839, FT522, FT825, and FT836.
Site analysis states Fate is advancing multiplexed-engineered T-cell and NK-cell product candidates for autoimmune diseases and cancer.
FT538 NK cell therapy with monoclonal antibodies for advanced solid tumors
phase 1drug program · medium
Evaluate FT538 in combination with monoclonal antibodies in advanced solid tumors.
Clinical trial record describes FT538 in combination with monoclonal antibodies in advanced solid tumors; supplied material also lists an FT538 publication record.
Clinical trial record supplied for FT538 in combination with monoclonal antibodies in advanced solid tumors.
FT538 NK-cell therapy with monoclonal antibodies for advanced solid tumors
phase 1drug program · medium
Evaluate FT538 in combination with monoclonal antibodies for advanced solid tumors.
Clinical trial of FT538 in combination with monoclonal antibodies in advanced solid tumors.
Clinical trial record supplied for FT538 in combination with monoclonal antibodies in advanced solid tumors.
FT839 dual-CAR T-cell therapy for autoimmune disease
preclinicaldrug program · medium
Develop an off-the-shelf dual-CAR T-cell therapy that targets multiple antigens on pathogenic B and T cells for autoimmune diseases.
Multi-antigen targeting off-the-shelf dual-CAR T-cell product candidate generated from Fate's iPSC cell programming platform.
2026 EULAR presentation titled 'FT839: A Multi-Antigen Targeting Off-the-Shelf Dual-CAR T Cell for the Treatment of Pathogenic B and T Cells in Autoimmune Diseases'.
FT839 dual-CAR T-cell therapy for autoimmune diseases
preclinicaldrug program · medium
Treat autoimmune diseases by targeting pathogenic B and T cells with a multi-antigen off-the-shelf dual-CAR T-cell product.
Multiplex-engineered off-the-shelf dual-CAR T-cell therapy derived from Fate's iPSC cell programming platform.
2026 EULAR presentation/poster on FT839 as a multi-antigen targeting off-the-shelf dual-CAR T cell for pathogenic B and T cells in autoimmune diseases.
iPSC-derived off-the-shelf cellular immunotherapy platform
exploratoryplatform · high
Create renewable, clonal master iPSC lines for mass production of programmed off-the-shelf T-cell and NK-cell immunotherapies.
Engineered human induced pluripotent stem cells, clonal master iPSC lines, multiplex cell engineering, cryopreservation, and stability assessment of engineered iPSC banks and derived T/NK cells.
Company pipeline and publications describe the iPSC platform and multiple 2022 presentations on high-density cryopreservation, long-term stability of cryopreserved iPSC-derived T and NK cells, and 10-year stability of engineered iPSC banks.
Supplied publication titles report that high-density cryopreservation facilitates on-demand CAR-cell access, long-term stability supports mass production and off-the-shelf therapeutic applications, and 10-year stability assessment characterized cryopreserved engineered iPSC banks.
Next-generation multi-antigen CAR T cells for conditioning-free B-cell lymphoma treatment
preclinicalresearch program · medium
Develop next-generation multi-antigen targeting off-the-shelf CAR T cells for conditioning-free treatment of B-cell lymphoma.
Research and presentation program focused on multi-antigen targeting off-the-shelf CAR T-cell engineering.
2025 ASH abstract titled 'Development of Next Generation Multi-Antigen Targeting Off-the Shelf CAR T-Cells for Conditioning-Free Treatment of B-Cell Lymphoma'.
Off-the-shelf CAR cell cryopreservation and iPSC bank stability program
exploratoryresearch program · medium
Support mass production, long-term banking, and on-demand treatment access for off-the-shelf iPSC-derived cellular therapies.
High-density cryopreservation studies, long-term stability assessment of cryopreserved iPSC-derived T and NK cells, and 10-year stability assessment of cryopreserved engineered iPSC banks with genetic and phenotypic characterization.
2022 presentations/publications listed on high-density cryopreservation, long-term cryopreserved iPSC-derived T/NK cell stability, and 10-year engineered iPSC bank stability.
Publication titles state that cryopreservation facilitates on-demand treatment access and supports mass production/off-the-shelf therapeutic applications; detailed data were not supplied.
