Gracell Biotechnologies' In Vivo CAR-T Candidate GT801 Selected for Oral Presentation at ASH 2025
Grit Biotherapeutics
Developer of Immunotherapy Drugs for Solid Tumors
Grit Biotechnology recently announced that the company's GT801 in vivo CAR breakthrough research has been invited for an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting in 2025. Grit researchers will present the latest research progress on GT801 at the ASH conference to clinicians, academics, and industry professionals from institutions worldwide. GT801 is developed by a controlling subsidiary under the Grit Group.MicroTao BioIndependently developed, based on CLAMP technology to achieve T-LNP positioning and quantitative coupling, thereby enabling precise mRNA delivery in vivo, achieving efficient expansion and persistence of CAR-T cells in vivo. The ASH meeting will be held from December 6 to 9, 2025, in Orlando, Florida, USA. Detailed information about the oral presentation by Grail is as follows:
Title：Precision In Vivo CAR-T generation via CLAMP-enabled mRNA delivery: Toward scalable and translatable cell therapy
Topic Name：CAR-T Cell Therapies: Basic and Translational: In vivo CAR-T cell platforms and resistance mechanisms
Display Time: December 6, 2025 (Thursday) 9:30 AM – 9:45 PM (Local Time)
Oral Presenter: Chief Scientific Officer Professor Wang Pin
Display Area：OCCC - Sunburst Room (W340)
"GT801 is an innovative anti-CD19 in vivo CAR product that delivers optimized mRNA through T cell-targeted LNP. By collaborating with Tianze Cloud Tech, we utilize the patented CLAMP technology to achieve precise localization and quantitative coupling of T cell-targeted VHH antibodies with LNPs. This enhances targeting efficiency while avoiding non-specific uptake, promoting specific and efficient CAR expression and maximizing the functionality of CAR-T cells generated in vivo. Through systematic optimization, GT801 induces sustained CAR-T expression in PBMCs for over 14 days in vitro. In vivo, GT801 achieves >80% CAR expression in T cells across tissues, with less than 1% off-target delivery in myeloid cells (including monocytes, macrophages, and dendritic cells) and hepatocytes in multiple tissues."
Dr. Yarong Liu, Chairman and CEO of Gracell Biotechnologies and MicroTide Bioscience, stated, "In the PBMC humanized mouse model, a single dose of GT801 as low as 0.01 mg/kg can achieve >95% B-cell depletion in the spleen. After a single dose, T cells can expand approximately 30-fold in HSC humanized mice. With increased dosing, CAR-T cell expansion in vivo demonstrates a cascading amplification effect while showing minimal release of cytokines such as IL-6 and TNF-α, supporting the feasibility and safety of repeated GT801 dosing. Preliminary clinical data confirms efficient CAR expression post-dosing, profound B-cell depletion, and the feasibility of repeat dosing. We will present the latest clinical progress of GT801 at the ASH conference."
