Grit Biotherapeutics' In Vivo CAR-T Therapy GT801 Selected for Oral Presentation at ASH 2025
核心洞察
Grit Biotherapeutics (搜索)' GT801 (搜索) in vivo CAR-T program has been selected for an oral presentation at the 67th American Society of Hematology Annual Meeting in December 2025.
GT801 (搜索) demonstrated >95% B-cell clearance at doses as low as 0.01 mg/kg and >80% CAR expression across tissue-resident T cells in preclinical studies.
The therapy uses proprietary CLAMP technology with T-cell-targeted lipid nanoparticles to achieve selective targeting and minimal off-target effects.
Grit Biotherapeutics (搜索) Co., Ltd., a clinical-stage biopharmaceutical company, announced that its groundbreaking GT801 (搜索) in vivo CAR-T program has been selected for an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting, scheduled for December 6-9, 2025, in Orlando, Florida.
The abstract, titled "Precision In Vivo CAR-T Generation via CLAMP-Enabled mRNA Delivery: Toward Scalable and Translatable Cell Therapy," was accepted in the CAR-T Cell Therapies: Basic and Translational session. Professor Pin Wang, Chief Scientific Officer of Grit Biotherapeutics (搜索), will deliver the presentation on Saturday, December 6, at 9:30-9:45 AM local time at the OCCC – Sunburst Room (W340).
Revolutionary In Vivo CAR-T Technology
GT801 (搜索) represents an innovative anti-CD19 (搜索) in vivo CAR-T candidate developed using T-cell-targeted lipid nanoparticles (T-LNPs) encapsulating optimized mRNA. The therapy leverages Grit Bio's proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology to achieve site-specific antibody conjugation and precise ligand density control. This approach enables selective T-cell targeting, minimal off-target uptake, and robust, durable CAR expression following systemic administration.
Impressive Preclinical Results
In preclinical studies, GT801 (搜索) demonstrated remarkable efficacy and safety profiles:
- Greater than 95% B-cell clearance in humanized PBMC mouse models at doses as low as 0.01 mg/kg
- Greater than 80% CAR expression across tissue-resident T cells with less than 1% off-target delivery to myeloid and hepatic cells
- 30-fold in vivo expansion of CAR-T cells with minimal cytokine release (IL-6, TNF-α), supporting the safety and feasibility of repeat dosing
Clinical Validation and Future Potential
Preliminary clinical data further validate the therapy's potential, demonstrating efficient CAR expression, deep B-cell depletion, and repeat-dose tolerability. These findings highlight GT801 (搜索)'s strong potential as a scalable, off-the-shelf immunotherapy candidate.
"The invitation to present at ASH 2025 highlights international recognition of Grit Bio's leadership in advancing in vivo CAR-T innovation," said Dr. Yarong Liu, Chairman and CEO of Grit Biotherapeutics (搜索). "Our GT801 (搜索) platform represents a paradigm shift in cell therapy—transforming complex ex vivo manufacturing into a simple, repeatable, and scalable in vivo process. We are eager to share our latest clinical data and explore global partnerships that accelerate the translation of this breakthrough technology to patients worldwide."
Company Background
Founded in 2019, Grit Biotherapeutics (搜索) is an innovation-driven, late-stage biopharmaceutical company pioneering next-generation immunotherapies for patients with cancer (搜索) and autoimmune diseases (搜索) worldwide. The company's R&D focuses on TIL-based therapies and in vivo/off-the-shelf cell therapies for solid tumors (搜索) and hematologic malignancies (搜索). Grit's lead product GT101, the first TIL therapy approved for clinical trials in China, is currently in Phase II pivotal studies. The company's GT201, the world's first membrane-bound IL-15 (搜索) complex–engineered TIL product, has received IND clearance in China and the U.S.