Fate Therapeutics, Inc. is a clinical-stage biopharmaceutical firm dedicated to creating advanced, programmed cellular immunotherapies. These innovative treatments are designed to combat cancer and various immune disorders across the globe. A significant portion of its development pipeline concentrates on NK- and T-cell immuno-oncology programs. Key candidates include FT516, which targets acute myeloid leukemia (AML), B-cell lymphoma, and advanced solid tumors; FT596 for B-cell lymphoma and chronic lymphocytic leukemia; FT538, addressing AML and multiple myeloma; FT576, also focused on multiple myeloma; FT819, aimed at both hematologic malignancies and solid tumors; FT536, another program for solid tumors; and FT500, intended for advanced solid tumors. The company also actively engages in strategic collaborations to advance its research and development. It holds an agreement with Ono Pharmaceutical Co. Ltd. for the joint development and commercialization of two novel, "off-the-shelf" iPSC-derived CAR T-cell therapies. Furthermore, Fate Therapeutics maintains a research collaboration and licensing deal with Juno Therapeutics, Inc., focusing on identifying small molecule modulators that can enhance the therapeutic efficacy of genetically engineered T-cell immunotherapies. A separate collaboration and option agreement exists with Janssen Biotech, Inc. Established in 2007, Fate Therapeutics, Inc. is based in San Diego, California.
Fate Therapeutics Initiates Potentially Registrational RECLAIM-LN Clinical Trial of FT819 for the Treatment of Lupus Nephritis
Fate Therapeutics initiated the RECLAIM-LN Phase 2 potentially registrational trial of FT819 for lupus nephritis, dosing the first patient in an outpatient setting.
The study aims to enroll approximately 53 patients refractory to standard therapies, with full enrollment anticipated by the first half of 2028.
Supported by FT819's RMAT designation, the trial utilizes a single 900 million-cell dose and targets complete renal response at Week 26 as its primary endpoint.