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
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
27-year-old African American-Asian Woman with Active Lupus Nephritis Achieved DORIS Clinical Remission; Patient Remains On-study, in Clinical Remission, and Free of All Immunosuppressive Therapies
一名27歲的非裔美國人-亞裔女性，活躍的狼瘡性腎炎實現了DORIS臨床緩解；患者繼續參加研究，處於臨床緩解狀態，並且沒有接受任何免疫抑制療法。
Patient Treated with Fludarabine-free Conditioning and Single-dose FT819; Favorable Safety Profile with No Grade ≥3 Adverse Events and No Events of CRS, ICANS, or GvHD
患者接受了無氟達拉濱的預處理和單劑量FT819治療；安全性良好，沒有3級及以上的不良事件，也沒有發生CRS、ICANS或GvHD事件。
Reconstituted B Cell Compartment Predominantly Consists of Naïve, Non-class Switched B Cells with Deep Depletion of Aberrant B Cells and Plasmablasts, Indicative of Immune Reset
重建的B細胞群主要由未激活的非經典轉化B細胞組成，表現出異常B細胞和漿母細胞的深度耗竭，表明免疫重置。
Second Treatment Arm Adding FT819 to Maintenance Therapy without Conditioning Chemotherapy Opened for Enrollment
第二治療組在維持治療中添加了FT819，無需預處理化療，現已開放報名。
SAN DIEGO, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, 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. The patient, a 27-year-old African American-Asian woman diagnosed with lupus nephritis (LN) over ten years ago, received fludarabine-free conditioning followed by a single dose of FT819. The patient achieved DORIS (definition of remission in SLE) clinical remission and LLDAS (low lupus disease activity state) as of Month 6 follow-up. The patient continues on-study, in clinical remission, and free of all immunosuppressive therapies as of a data cutoff date of November 11, 2024. FT819 is the Company's off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate comprised of CD8αβ+ T cells with a memory phenotype and high CXCR4 expression to promote tissue trafficking.
聖地亞哥，2024年11月18日（環球新聞）——Fate Therapeutics, Inc.（納斯達克：FATE）是一家臨床階段的生物製藥公司，致力於將首創的誘導多能幹細胞（iPSC）來源的細胞免疫療法帶給癌症和自身免疫疾病患者，今天在美國風溼病學會（ACR）在華盛頓特區舉行的Convergence會議上，展示了首名接受FT819 I期自身免疫研究治療的患者的初步臨床和轉化數據。這名患者是一位27歲的非裔美國人-亞裔女性，十多年前被診斷爲狼瘡性腎炎（LN），接受了無氟達拉濱的預處理後，給予了一劑FT819。該患者在第6個月隨訪時實現了DORIS（SLE中緩解的定義）臨床緩解和LLDAS（低狼瘡疾病活動狀態）。截至2024年11月11日的數據截止日，該患者繼續參與研究，處於臨床緩解狀態，並且沒有接受任何免疫抑制療法。FT819是公司現成的CD19靶向1XX CAR T細胞產品候選藥物，包含CD8αβ+ T細胞，具備記憶表型和高CXCR4表達，以促進組織遷移。
譯文內容由第三人軟體翻譯。
