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

Vivacta Bio has announced significant initial findings from its first-in-human study of GT801, a novel in vivo CAR-T therapy targeting CD19, aimed at treating non-Hodgkin’s lymphoma. The results were presented by Dr. Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, during an oral session at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, on December 6, 2025.

This Phase 1 study, which is investigator-initiated, is designed to assess the safety, tolerability, and preliminary efficacy of repetitively administering GT801 to patients with relapsed or refractory CD19-positive B-cell malignancies. Notably, as of the November 30, 2025 data cutoff, two patients with non-Hodgkin’s lymphoma had successfully completed multiple doses of GT801 without the use of lymphodepleting chemotherapy.

Both patients displayed a robust CAR expression in circulating T cells, indicating that functional CAR-T cells can be generated in vivo without prior cytotoxic conditioning. Patient 1 received three doses of 0.5 mg, while Patient 2 received four doses at 1.5 mg. Overall, GT801 was well tolerated, with no adverse effects reported that would raise safety concerns.

The therapy demonstrated rapid pharmacodynamic activity, leading to substantial B-cell depletion in peripheral blood and various tissues, including bone marrow and lymph nodes. By Week 4 after the final GT801 infusion, both patients achieved a partial response, as assessed by investigators.

Dr. Yarong Liu, Founder and CEO of Vivacta Bio, expressed optimism regarding the findings. “We are encouraged by the promising safety profile and compelling efficacy signals observed with GT801 in heavily pretreated NHL patients,” she 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

GT801 represents a groundbreaking investigational therapy that 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 (Controllable Ligand Attachment Modification and Purification) technology, which allows for site-specific antibody conjugation and precise control over ligand density. This design aims to enhance selective T-cell targeting while minimizing off-target effects.

The objective behind GT801 is to create effective CAR-T cells directly within the patient, which supports the potential for repeat dosing and eliminates the traditional need for ex vivo cell manufacturing processes.

About Vivacta Bio

Vivacta Bio is a biotechnology company focused on developing advanced in vivo CAR-T therapies for cancer and autoimmune diseases. By leveraging innovations in T-cell-targeted LNP design and advanced mRNA engineering, the company aims to simplify complex cell-manufacturing workflows, making treatments more accessible and scalable for patients worldwide. Vivacta Bio operates from its headquarters in Shanghai, China.

About Grit Biotherapeutics

Founded in 2019, Grit Biotherapeutics is dedicated to pioneering next-generation immunotherapies for cancer and autoimmune conditions. The company’s research and development efforts are concentrated on tumor-infiltrating lymphocyte (TIL)-based therapies and in vivo, off-the-shelf cell therapy platforms for various malignancies. Grit’s lead product, GT101, is the first TIL therapy to gain approval for clinical trials in China and is currently undergoing Phase II pivotal studies. Additionally, GT201, the first engineered TIL product utilizing a membrane-bound IL-15 complex, has received Investigational New Drug (IND) clearance in both China and the United States.

For further inquiries, media representatives can contact Grit Biotherapeutics at [email protected] or visit their website at www.grit-bio.com.