Vivacta Bio Reveals Promising GT801 Therapy Results for Non-Hodgkin’s Lymphoma

Vivacta Bio has announced encouraging initial findings from its first-in-human study of GT801, an innovative in vivo CAR-T therapy aimed at treating non-Hodgkin’s lymphoma. The results were unveiled on December 6, 2025, during a presentation at the American Society of Hematology (ASH) Annual Meeting held in Orlando, Florida. This study represents a significant step forward in the development of CAR-T therapies, particularly for patients with relapsed or refractory CD19-positive B-cell malignancies.

The Phase 1 study was investigator-initiated and focused on assessing the safety, tolerability, and preliminary efficacy of GT801 in patients who had undergone extensive previous treatments. As of November 30, 2025, two patients with non-Hodgkin’s lymphoma received multiple doses of GT801 without the need for lymphodepleting chemotherapy. This approach demonstrated the feasibility of generating functional CAR-T cells in vivo, marking a departure from traditional methods that require cytotoxic conditioning.

Patient 1 received three doses of 0.5 mg, while Patient 2 received four doses of 1.5 mg. Notably, GT801 was well tolerated by both individuals. Investigators observed high CAR expression within circulating T cells, with both patients showing durable and repeatable CAR-T expansion following each administration. The absence of CAR expression in peripheral blood monocytes further indicates the selectivity of the T-LNP platform, minimizing off-target effects.

By the fourth week after the final GT801 infusion, both patients achieved a partial response, a positive indicator of the therapy’s efficacy. “We are encouraged by the promising safety profile and compelling efficacy signals observed with GT801 in heavily pretreated NHL patients,” said Dr. Yarong Liu, Founder and CEO of Vivacta Bio. “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.”

Innovative Technology Behind GT801

GT801 utilizes T-cell–targeted lipid nanoparticles (T-LNPs) to deliver optimized mRNA encoding an anti-CD19 CAR. This technology integrates Grit Bio‘s proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) methodology. This novel approach allows for precise antibody conjugation, controlled ligand density, and selective targeting of T-cells, all while minimizing off-target uptake.

The objective of GT801 is to create potent and persistent CAR-T cells directly within the patient. This eliminates the need for traditional ex vivo cell manufacturing, which can be resource-intensive and complicated. By streamlining the treatment process, Vivacta Bio aims to make advanced immunotherapies more accessible on a global scale.

About Vivacta Bio and Grit Biotherapeutics

Vivacta Bio is a biotechnology firm focused on developing next-generation in vivo CAR-T therapies to treat cancer and autoimmune diseases. The company utilizes innovations in T-cell–targeted LNP design and advanced mRNA engineering to transform complex cell-manufacturing workflows into a convenient and scalable treatment paradigm. Headquartered in Shanghai, China, Vivacta Bio seeks to broaden patient access to transformative immunotherapies.

Founded in 2019, Grit Biotherapeutics is an innovative biopharmaceutical company dedicated to pioneering immunotherapies for cancer and autoimmune diseases. Their research and development efforts focus on tumor-infiltrating lymphocyte (TIL)-based therapies and in vivo, off-the-shelf cell therapy platforms. Grit’s lead product, GT101, is currently undergoing Phase II pivotal studies in China, marking significant progress in the field of cancer treatment.

The promising results of GT801 could pave the way for future advancements in CAR-T therapy, offering hope to patients who have exhausted other treatment options. As research continues, the potential for greater accessibility and efficacy in cancer treatment is becoming increasingly tangible.