Grit Biotherapeutics, a leading clinical-stage biopharmaceutical company pioneering next-generation immunotherapies, today announced that its groundbreaking GT801 in vivo CAR-T program has been selected for an oral presentation at the upcoming 67th American Society of Hematology (ASH) Annual Meeting, to be held December 6–9, 2025, in Orlando, Florida, USA.
Preliminary clinical data further validate efficient CAR expression, deep B-cell depletion, and repeat-dose tolerability, highlighting GT801’s strong potential as a scalable, off-the-shelf immunotherapy candidate.
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. The presentation will be delivered by Professor Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, on Saturday, December 6, 9:30–9:45 AM (local time) at the OCCC – Sunburst Room (W340).
GT801 is an innovative anti-CD19 in vivo CAR-T candidate developed using T-cell-targeted lipid nanoparticles (T-LNPs) encapsulating optimized mRNA. Grit Bio leveraged the proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology to achieve site-specific antibody conjugation and precise ligand density control. This approach allows selective T-cell targeting, minimal off-target uptake, and robust, durable CAR expression following systemic administration.
In preclinical studies, GT801 demonstrated:
- >95% B-cell clearance in humanized PBMC mouse models at doses as low as 0.01 mg/kg;
- >80% CAR expression across tissue-resident T cells with <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.
Preliminary clinical data further validate efficient CAR expression, deep B-cell depletion, and repeat-dose tolerability, highlighting GT801’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.
“Our GT801 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.”
Featured image: ASH 2015. Photo courtesy: © 2014 – 2025. Used with permission
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