Fate Therapeutics Inc. is advancing two Phase 1 clinical studies evaluating novel off-the-shelf CAR-T cell therapies for advanced solid tumors, marking significant progress in the company's oncology pipeline. The studies are investigating FT836 and FT825, both designed to target challenging cancer types that have historically been difficult to treat with traditional CAR-T approaches.
FT836 Study Targets Multiple Solid Tumor Types
The company's Phase 1 study of FT836 is an open-label investigation evaluating the therapy with or without chemotherapy and monoclonal antibodies in participants with advanced solid tumors. The study encompasses multiple cancer types including lung, colorectal, breast, ovarian, endometrial, and head and neck cancers.
The primary objective focuses on establishing the recommended Phase 2 dose of FT836 in combination with trastuzumab or cetuximab, with or without paclitaxel chemotherapy. This interventional study follows a non-randomized, sequential intervention model with an open-label design, allowing for flexibility in assessing the effectiveness of different drug combinations.
The study began on October 8, 2025, with primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on October 9, 2025, indicating ongoing recruitment and active progress in the trial.
FT825 Focuses on HER2-Positive Tumors
The second Phase 1 study evaluates FT825, another off-the-shelf CAR-T cell therapy, in patients with HER2-positive or other advanced solid tumors. This study aims to assess the safety, tolerability, and antitumor activity of FT825 administered alone or in combination with the monoclonal antibody cetuximab.
The FT825 study follows an interventional, non-randomized, parallel model design with no masking, focusing primarily on treatment evaluation. The study began on January 27, 2024, with a recent update provided on July 17, 2025, demonstrating sustained progress in the research.
Clinical Significance and Market Impact
Both studies represent innovative approaches to treating advanced solid tumors, which have traditionally posed significant challenges for CAR-T cell therapy development. The off-the-shelf nature of these therapies could potentially address manufacturing and accessibility limitations associated with autologous CAR-T treatments.
The clinical updates could positively influence Fate Therapeutics' market position by showcasing progress in innovative cancer treatments and potentially attracting investor interest. The company's advancements occur within a competitive landscape that includes other biotech firms exploring CAR-T cell therapies, highlighting the significance of these developments in the field.
Both studies are currently recruiting participants, with detailed information available through the ClinicalTrials portal. The parallel development of two distinct CAR-T platforms demonstrates Fate Therapeutics' comprehensive approach to addressing the unmet medical needs in solid tumor treatment.
