Vivacta Bio Reveals Promising GT801 CAR-T Results at ASH 2025

Vivacta Bio has announced encouraging preliminary findings from its first-in-human study of GT801, a novel in vivo CAR-T therapy targeting CD19, during the 2025 annual meeting of the American Society of Hematology (ASH) in Orlando, Florida. The data was presented by Dr. Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, on December 6, 2025, highlighting potential advancements in CAR-T treatment delivery.

The Phase 1 study, investigator-initiated, focuses on assessing the safety, tolerability, and preliminary efficacy of GT801 in patients with relapsed or refractory CD19-positive B-cell malignancies, specifically non-Hodgkin’s lymphoma. As of the November 30, 2025 data cutoff, two patients had received multiple doses of GT801 without the use of lymphodepleting chemotherapy, demonstrating the potential of generating functional CAR-T cells in vivo without cytotoxic conditioning.

Patient 1 received three doses of 0.5 mg, while Patient 2 received four doses of 1.5 mg. Both patients tolerated the treatment well, with high CAR expression observed in their circulating T cells. Notably, durable CAR-T expansion was recorded following each GT801 administration, and no CAR expression was detected in peripheral blood monocytes, indicating minimal off-target effects.

The therapy also exhibited rapid pharmacodynamic activity. Both patients showed significant B-cell depletion in peripheral blood and across multiple tissues, including bone marrow and lymph nodes. By Week 4 post-infusion, both individuals achieved a partial response, as assessed by investigators.

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 Its Development

GT801 is an investigational in vivo CAR-T product candidate that employs T-cell–targeted lipid nanoparticles (T-LNPs) to deliver optimized mRNA encoding an anti-CD19 CAR. Utilizing the proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology, GT801 allows for precise ligand density control and selective T-cell targeting while minimizing off-target uptake.

This innovative approach facilitates the generation of potent and persistent CAR-T cells directly within patients, supporting repeat dosing and eliminating the need for conventional ex vivo cell manufacturing.

The Vision of Vivacta Bio

Vivacta Bio is at the forefront of developing advanced in vivo CAR-T therapies aimed at treating cancer and autoimmune diseases. The company seeks to transform complex cell-manufacturing workflows into a scalable and repeatable treatment model, broadening access to these potentially life-saving immunotherapies.

Based in Shanghai, China, Vivacta Bio leverages cutting-edge innovations in T-cell–targeted LNP design and advanced mRNA engineering to enhance patient care.

Grit Biotherapeutics, founded in 2019, is pioneering next-generation immunotherapies, focusing on tumor infiltrating lymphocyte (TIL)-based therapies and innovative cell-therapy platforms for various malignancies. Its lead product, GT101, is currently in Phase II pivotal studies, while GT201, the world’s first membrane-bound IL-15 complex–engineered TIL product, has received regulatory clearance in both China and the United States.

As the landscape of cancer treatment evolves, Vivacta Bio’s promising results with GT801 may pave the way for more accessible and effective therapies for patients worldwide.