Vivacta Bio Unveils Promising Results for GT801 in Non-Hodgkin’s Lymphoma

Vivacta Bio has announced promising initial results from a first-in-human study of its investigational therapy GT801, designed for in vivo CAR-T treatment in patients with non-Hodgkin’s lymphoma. The findings were presented by Dr. Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, during an oral session at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, on December 6, 2025.

GT801 is a T-LNP/mRNA-based CAR-T candidate targeting CD19, aimed at addressing the needs of patients with relapsed or refractory CD19-positive B-cell malignancies. The early clinical data highlights the safety, tolerability, and preliminary efficacy of administering GT801 without the need for lymphodepleting chemotherapy, a significant advancement in CAR-T therapy.

Study Highlights and Results

The Phase 1 investigator-initiated study involved multiple doses of GT801 administered to two patients suffering from non-Hodgkin’s lymphoma. As of the data cutoff on November 30, 2025, both patients completed several doses—Patient 1 received three doses of 0.5 mg, while Patient 2 received four doses of 1.5 mg. The results indicated that GT801 was generally well tolerated, with both patients exhibiting high CAR expression within circulating T cells.

The study revealed durable CAR-T cell expansion following each administration, a promising sign of the therapy’s efficacy. Notably, no CAR expression was detected in peripheral blood monocytes, suggesting minimal off-target effects and reinforcing the selective delivery capabilities of the T-LNP platform. Pharmacodynamic activity was rapid, leading to significant B-cell depletion in both peripheral blood and various tissues, including bone marrow and lymph nodes.

By the fourth week following the final infusion of GT801, both patients achieved a partial response as assessed by investigators. Dr. Yarong Liu, Founder and CEO of Vivacta Bio, expressed optimism regarding the therapy’s potential. “We are encouraged by the promising safety profile and compelling efficacy signals observed with GT801 in heavily pretreated NHL patients,” she noted. “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 represents a novel approach in the field of CAR-T therapies. It utilizes T-cell–targeted lipid nanoparticles (T-LNPs) to deliver optimized mRNA encoding an anti-CD19 CAR. This innovative platform incorporates Grit Bio’s proprietary CLAMP technology, which facilitates site-specific antibody conjugation, precise control of ligand density, and selective targeting of T-cells while minimizing off-target uptake. This design aims to produce potent and long-lasting CAR-T cells directly within patients, making repeat dosing feasible and eliminating the complexities of traditional ex vivo cell manufacturing.

Vivacta Bio, headquartered in Shanghai, China, focuses on developing next-generation in vivo CAR-T therapies for cancer and autoimmune diseases. By leveraging advances in T-cell–targeted LNP design and mRNA engineering, the company seeks to revolutionize cell-manufacturing workflows, enhancing global access to effective immunotherapies.

Founded in 2019, Grit Biotherapeutics is dedicated to pioneering innovative immunotherapies for cancer and autoimmune disorders. The company is currently advancing its lead product GT101, the first tumor-infiltrating lymphocyte therapy approved for clinical trials in China, and GT201, the first membrane-bound IL-15 complex-engineered TIL product, which has received IND clearance in both China and the United States.

As research progresses, Vivacta Bio’s work with GT801 could significantly alter the treatment landscape for patients with non-Hodgkin’s lymphoma, offering new hope for effective and accessible therapies.