Vivacta Bio Reveals Positive Phase 1 Results for GT801 at ASH 2025

Vivacta Bio announced promising initial results from a first-in-human study of its investigational therapy, GT801, targeting non-Hodgkin’s lymphoma. The data, presented on December 6, 2025, at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, highlights the potential of GT801 as an in vivo CAR-T therapy for patients suffering from relapsed or refractory CD19-positive B-cell malignancies.

The study, led by Dr. Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, focused on evaluating the safety, tolerability, and preliminary efficacy of GT801. This innovative therapy utilizes lipid nanoparticles to deliver mRNA encoding an anti-CD19 CAR directly into T cells, eliminating the need for traditional lymphodepleting chemotherapy. As of the data cutoff on November 30, 2025, two patients with non-Hodgkin’s lymphoma successfully completed multiple administrations of GT801, showcasing its feasibility in generating functional CAR-T cells without cytotoxic conditioning.

Both participants experienced favorable outcomes with GT801. Patient 1 received three doses of 0.5 mg, while Patient 2 received four doses of 1.5 mg. Both exhibited high CAR expression in circulating T cells, with durable CAR-T expansion following each administration. Notably, no CAR expression was found in peripheral blood monocytes, indicating the high selectivity of the T-LNP platform and minimal off-target effects.

GT801 demonstrated rapid pharmacodynamic activity, resulting in significant B-cell depletion in peripheral blood and various tissues. By Week 4 after the final infusion, both patients achieved a partial response according to investigator assessment.

Dr. Yarong Liu, Founder and CEO of Vivacta Bio, expressed optimism regarding the findings, stating, “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.”

About GT801 and Vivacta Bio

GT801 is an investigational product candidate designed to deliver CAR-T therapy directly within the patient’s body. The treatment utilizes T-cell-targeted lipid nanoparticles to facilitate mRNA delivery, employing Grit Bio’s proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology. This technology supports precise antibody conjugation, ligand density control, and selective T-cell targeting while minimizing off-target uptake.

Vivacta Bio is committed to advancing next-generation in vivo CAR-T therapies aimed at treating cancer and autoimmune diseases. The company leverages innovations in T-cell-targeted lipid nanoparticle design and advanced mRNA engineering to transform complex cell-manufacturing processes into a scalable, repeatable treatment model accessible to patients globally.

Founded in 2019, Grit Biotherapeutics focuses on pioneering immunotherapies for cancer and autoimmune conditions. The company is currently advancing multiple product candidates, including GT101, the first TIL therapy approved for clinical trials in China, and GT201, an engineered TIL product that has received IND clearance in both China and the United States.

As the field of CAR-T therapy continues to evolve, the early results from the GT801 study mark an important milestone that could reshape treatment options for patients battling non-Hodgkin’s lymphoma and similar conditions.