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Vivacta Bio's Promising GT801 Results Present a Future in CAR-T Therapy

At the 2025 American Society of Hematology (ASH) Annual Meeting held in Orlando, Florida, Vivacta Bio, a spin-off of Grit Biotherapeutics, made headlines with its announcement regarding GT801, an investigational in vivo CAR-T therapy candidate. This therapy targets CD19, a protein often associated with non-Hodgkin's lymphoma and other B-cell malignancies, showcasing promising initial results from a first-in-human study. Dr. Pin Wang, the Chief Scientific Officer at Grit Biotherapeutics, presented these striking findings, which could reshape how CAR-T therapies are currently administered and accessed.

Initial Findings from the Phase 1 Study

The focus of this Phase 1 investigator-initiated study was to evaluate the safety, tolerability, and preliminary efficacy of repeated GT801 doses in patients suffering from relapsed or refractory CD19-positive B-cell malignancies. Impressively, the latest data was collected until November 30, 2025, demonstrating the successful completion of multiple GT801 administrations in two patients with non-Hodgkin's lymphoma, performed without the traditional lymphodepleting chemotherapy. This is a significant breakthrough, indicating the potential for generating functional CAR-T cells directly in vivo.

In this study:

• - Patient 1 received three doses of 0.5 mg and Patient 2 received four doses of 1.5 mg of GT801.
• - Both patients exhibited a robust expression of CAR within their circulating T cells, illustrating the treatment's efficacy.
• - The study also documented a durable and repeatable CAR-T cell expansion following each dose, revealing the treatment's reproducibility.
• - Further observations revealed no detectable CAR expression in peripheral blood monocytes, suggesting an impressive selectivity of the targeted delivery system provided by the T-LNP platform used for GT801.

The Therapeutic Impact of GT801

Notably, GT801 demonstrated rapid pharmacodynamic activity—effectively leading to substantial depletion of B-cells across various tissues, including bone marrow and lymph node biopsies. By the fourth week after the final infusion of GT801, both patients reached a partial response according to investigator assessments, marking a positive indicator for future applications of this therapy.

Dr. Yarong Liu, the Founder and CEO of Vivacta Bio, stated, "We are encouraged by the promising safety profile and compelling efficacy signals observed with GT801 in heavily pretreated NHL patients. These initial findings demonstrate GT801's ability to generate potent, repeatable CAR-T responses without lymphodepleting chemotherapy – a major step forward for scalability, patient accessibility, and commercial viability."

What Sets GT801 Apart?

The innovative design of GT801 utilizes a T-cell–targeted lipid nanoparticle (T-LNP) system, allowing the optimized delivery of mRNA encoding an anti-CD19 CAR directly within the body. This in vivo approach not only circumvents the complexities of ex vivo cell manufacturing, but also promotes a more convenient and scalable method for CAR-T therapy. The integration of Grit Bio's proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology further enhances the product's precision, allowing selective and efficient targeting of T-cells while minimizing off-target effects.

Conclusion: A Bright Future for CAR-T Treatments

Vivacta Bio is on a promising path towards revolutionizing CAR-T therapies not just for Non-Hodgkin's lymphoma, but potentially for a broad range of conditions classified under malignancies and autoimmune diseases. By eliminating the need for extensive cell manufacturing and presenting a systematized, repeatable process, Vivacta seems set to broaden global access to these revolutionary immunotherapies.

For those interested in innovations within biotechnology and oncological treatments, the developments surrounding GT801 are noteworthy, promising a future where effective and accessible cancer therapies are more than just a possibility, but an impending reality.