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

Vivacta Bio has reported encouraging initial findings from its first-in-human study of GT801, an innovative in vivo CAR-T therapy for patients with non-Hodgkin’s lymphoma (NHL). The results were revealed on December 6, 2025, during the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. Dr. Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, presented the data, which highlighted significant advancements in CAR-T treatment delivery.

The Phase 1 study, led by investigators, focuses on assessing the safety, tolerability, and preliminary efficacy of GT801 in patients with relapsed or refractory CD19-positive B-cell malignancies. As of the data cutoff on November 30, 2025, two patients with NHL completed multiple doses of GT801 without the need for lymphodepleting chemotherapy. This approach supports the feasibility of generating functional CAR-T cells directly within the patient’s body, a significant advancement in CAR-T therapy.

Both patients demonstrated high levels of CAR expression in circulating T cells. Patient 1 received three doses of 0.5 mg, while Patient 2 received four doses of 1.5 mg. The therapy was generally well tolerated, with no adverse effects reported. Notably, both patients exhibited durable and repeatable CAR-T cell expansion following each administration. Importantly, no CAR expression was observed in peripheral blood monocytes, indicating minimal off-target delivery from the T-LNP platform.

The pharmacodynamic activity of GT801 proved rapid and profound, leading to significant B-cell depletion in both peripheral blood and various tissues, including bone marrow and lymph nodes. By Week 4 following 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 early results. “We are encouraged by the promising safety profile and compelling efficacy signals observed with GT801 in heavily pretreated NHL patients,” he stated. “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 Its Development

GT801 represents an investigational, systemically administered in vivo CAR-T product that utilizes T-cell–targeted lipid nanoparticles (T-LNPs) to deliver optimized mRNA encoding an anti-CD19 CAR. This platform integrates Grit Bio’s proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology, which allows for site-specific antibody conjugation and precise control over ligand density, ensuring selective T-cell targeting with minimal off-target effects.

This innovative approach aims to produce effective and durable CAR-T cells directly within the patient, simplifying the process by eliminating the need for traditional ex vivo cell manufacturing. The advancements offered by GT801 are expected to broaden access to transformative immunotherapies.

About Vivacta Bio and Grit Biotherapeutics

Vivacta Bio, headquartered in Shanghai, China, is dedicated to developing next-generation in vivo CAR-T therapies that address both cancer and autoimmune diseases. By leveraging advancements in T-cell–targeted LNP design and mRNA engineering, the company seeks to transform complex cell-manufacturing workflows into convenient, scalable, and repeatable treatment options.

Grit Biotherapeutics, founded in 2019, is focused on pioneering new immunotherapies for cancer and autoimmune conditions. Their research and development efforts emphasize tumor-infiltrating lymphocyte (TIL)-based therapies and innovative cell-therapy platforms. The company’s lead product, GT101, is currently in Phase II pivotal studies, while GT201, the first membrane-bound IL-15 complex–engineered TIL product, has received investigational new drug clearance in both China and the United States.

As the landscape of CAR-T therapy evolves, Vivacta Bio’s GT801 may significantly impact treatment paradigms for patients battling challenging malignancies like non-Hodgkin’s lymphoma.