FT576 / Fate Therap - LARVOL DELTA

FT576 in Subjects With Multiple Myeloma (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Fate Therapeutics | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

FT576 in Subjects With Multiple Myeloma (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Fate Therapeutics | Recruiting ➔ Active, not recruiting | N=168 ➔ 31

Combination therapy • Enrollment change • Enrollment closed • Monotherapy • Hematological Malignancies • Multiple Myeloma • Oncology

Fate Therapeutics Reports First Quarter 2024 Financial Results and Business Updates (Fate Therapeutics Press Release) - P1 | N=168 | NCT05182073 | Sponsor: Fate Therapeutics | "The Company has completed dose escalation in its multi-center, Phase 1 clinical trial of FT576, its BCMA-targeted CAR NK cell product candidate, for relapsed / refractory multiple myeloma (NCT05182073). Using a standard conditioning chemotherapy regimen, 12 patients were treated with a three-dose treatment schedule at 1 billion cells per dose (n=6) or at 2.5 billion cells per dose (n=6) as monotherapy or in combination with CD38-targeted monoclonal antibody therapy. There were no dose-limiting toxicities and no events of any grade of CRS, ICANS or GvHD. Response assessment is ongoing at 2.5 billion cells per dose. Five of six (83%) heavily pre-treated patients achieved a clinical response at 1 billion cells per dose, including two penta-exposed patients treated with FT576 as monotherapy that achieved very good partial responses."

P1 data • Trial status • Multiple Myeloma

Fate Therapeutics Reports Second Quarter 2023 Financial Results and Business Updates (GlobeNewswire) - "The dose-escalation stage of the study is designed to assess the safety and activity of FT522 with and without administration of intensive conditioning chemotherapy to patients. The Company is conducting Phase 1 study start-up activities at multiple sites, and plans to initiate patient enrollment with a three-dose treatment schedule at 300 million cells per dose....The Company’s Phase 1 study of FT576, its multiplexed-engineered, BCMA-targeted chimeric antigen receptor (CAR) NK cell product candidate for relapsed / refractory multiple myeloma, is currently enrolling patients in two, three-dose treatment cohorts at 1 billion cells per dose."

Enrollment status • Trial status • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Interim Phase I Clinical Data of FT576 As Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma (ASH 2022) - "Outpatient conditioning chemotherapy consists of 3 consecutive days of fludarabine and cyclophosphamide administered prior to the first dose of FT576. Administration of a single dose of FT576 at 100 or 300 million cells/dose alone or in combination with daratumumab is safe and well tolerated thus far without CRS, neurotoxicity, or GvHD. Interim clinical data, including safety and tolerability and initial anti-tumor activity, from the ongoing Phase I dose-escalation study of FT576 will be presented at the conference."

Clinical data • Combination therapy • Monotherapy • P1 data • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammation • Multiple Myeloma • Oncology • IL15

"Stifel removes FT596 (discontinued) and FT576 too from its $FATE model. Investment case now highly leveraged on... FT819 (CD19 Car) $JNJ" (@JacobPlieth)

CD19

Fate Therapeutics Highlights iPSC-derived, Off-the-shelf CAR NK Cell Programs for Multiple Myeloma at 2022 ASH Annual Meeting (GlobeNewswire) - P1 | N=168 | NCT05182073 | Sponsor: Fate Therapeutics | "Interim Phase 1 Data of FT576 BCMA-targeted Product Candidate Show Clinical Activity in Initial Single-dose Escalation Cohorts as Monotherapy and in Combination with Daratumumab....Further evidence of FT576 activity was observed in the second dose cohort, with two patients for whom serum BCMA levels were evaluable showing a substantial treatment-induced decrease in soluble BCMA....No dose-limiting toxicities, and no events of any grade of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD), were observed."

Cytokine release syndrome • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Fate Therapeutics to Present Clinical and Preclinical Data for iPSC Product Platform at the 2022 ASH Annual Meeting (GlobeNewswire) - "The presentations include initial Phase 1 clinical data for FT576, the Company’s multiplexed-engineered, iPSC-derived CAR NK cell product candidate targeting BCMA for multiple myeloma, and for FT819, the Company’s iPSC-derived CAR T-cell product candidate targeting CD19 for B-cell lymphoma. In addition, the Company will jointly present with its collaboration partner Janssen preclinical data for FT555, a multiplexed-engineered, iPSC-derived CAR NK cell product candidate targeting GPRC5D, a tumor-associated orphan G-protein-coupled receptor found to be highly expressed on myeloma cells."

P1 data • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

"Any insight into whether the CD38 KO been validated as a method to reduce lymphodepletion for FT538 or FT576? (Or is it purely for use with anti-CD38 mAbs?)" (@Hab514)

FT576 in Subjects With Multiple Myeloma (clinicaltrials.gov) - P1; N=168; Recruiting; Sponsor: Fate Therapeutics

Clinical • Combination therapy • Monotherapy • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Fate Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Operational Progress (GlobeNewswire) - "GMP manufacture of FT576 is ongoing, and the Company is preparing to initiate a multi-center Phase 1 clinical trial to assess single-dose and multi-dose treatment regimens of FT576 as monotherapy and in combination with CD38-targeted monoclonal antibody therapy for the treatment of relapsed / refractory multiple myeloma."

Commercial • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

[VIRTUAL] FT576 path to first-of-kind clinical trial: translation of a versatile multi-antigen specific off-the-shelf NK cell for treatment of multiple myeloma (AACR 2021) - "The treatment of MM-bearing mice with both FT576 and daratumumab produced greater myeloma control than either agent alone, demonstrating combined CAR and antibody-directed cytotoxicity. Additionally, FT576 demonstrated enhanced persistence compared to peripheral blood NK cells, suggestive of antigen mediated expansion. Together, these studies demonstrate the versatility of FT576 as a highly effective multi-antigen targeting and cost-effective, off-the-shelf BCMA-CAR iNK cell product and support the rational for a first-of-kind Phase I Study of FT576 as a monotherapy or in combination with therapeutic mAbs targeted to MM-associated surface antigens."

Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology

[VIRTUAL] FT576: Multi-Specific Off-the-Shelf CAR-NK Cell Therapy Engineered for Enhanced Persistence, Avoidance of Self-Fratricide and Optimized Mab Combination Therapy to Prevent Antigenic Escape and Elicit a Deep and Durable Response in Multiple Myeloma (ASH 2020) - "There are multiple advantages in expanding treatment options beyond autologous primary T and NK cells, including the use of induced pluripotent stem cells (iPSC) to derive effector cells that can be uniformly manufactured at scale from renewable starting cellular material and where precision genetic engineering can be achieved at the clonal level which can be applied sequentially in order to build multiple specificities and functional modalities...Utilizing hnCD16, BCMA-CAR was tested in combination with anti-CD38 (daratumumab), anti-SLAMF7 (elotuzumab), or anti-CD19, showing synergistic increase in tumor targeting through various tumor associated antigens (TAAs)...Combination with other monoclonal antibodies displayed a similar response demonstrating the unique ability of FT576 to be directed to target multiple TAAs. Together, these studies demonstrate the versatility of FT576 as a highly effective multi-antigen targeting and cost-effective off-the-shelf BCMA-CAR iNK..."

Combination therapy • IO Biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • CD38

Fate Therapeutics Announces Twelve Presentations at the 2020 ASH Annual Meeting (Fate Therapeutics Press Release) - "Accepted abstracts include a clinical case study of a patient treated with FT596 at the first dose level (30 million cells) as a monotherapy in the Company’s Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma (NCT04245722)....In addition, the Company plans to host a virtual investor event entitled 'The Power of hnCD16' to highlight the unique therapeutic features and functionality of its novel hnCD16 Fc receptor, a core component incorporated in its iPSC-derived NK cell product candidates."

Clinical data • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology

"@JacobPlieth wrote about $SNY and Kiadis partnership in July 2020, and Kiadis K-NK004’s competitor $FATE FT538 and FT576. https://t.co/1EqWFGrsrV" (@jq1234t)

Licensing / partnership