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Vivacta Bio Announces Promising First-in-Human Results for GT801, an In Vivo CAR-T Therapy, in Non-Hodgkin's Lymphoma at the 2025 ASH Annual Meeting

GT801 showed durable CAR-T expansion and partial responses in NHL patients after repeat dosing, with good tolerability and minimal off-target effects, Vivacta Bio reported.

  • Vivacta Bio announced initial Phase 1 GT801 results at the 2025 ASH Annual Meeting, reporting encouraging preliminary data on safety and CAR-T expansion, with investigators highlighting potential for scalable treatment.
  • Vivacta Bio is developing in vivo CAR-T to support repeat dosing, with initial promising safety and efficacy signals in NHL patients, said Dr. Yarong Liu.
  • Investigators reported durable, repeatable CAR-T expansion after each GT801 dose, with Patient 1 receiving three doses of 0.5 mg and Patient 2 receiving four doses of 1.5 mg, both showing high CAR expression in circulating T cells and Week 4 partial responses.
  • GT801 induced rapid and deep B-cell depletion in peripheral blood, bone marrow and lymph nodes, was generally well tolerated, and showed no CAR expression in peripheral blood monocytes, supporting T-LNP platform selectivity.
  • If replicated in larger trials, the approach could broaden in vivo CAR-T scalability and repeat dosing by generating potent CAR-T cells without lymphodepleting chemotherapy, Dr.
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Vivacta Bio Announces Promising First-in-Human Results for GT801, an In Vivo CAR-T Therapy, in Non-Hodgkin's Lymphoma at the 2025 ASH Annual Meeting

SHANGHAI, Dec. 6, 2025 /PRNewswire/ -- Vivacta Bio, a spin-off company of Grit Biotherapeutics advancing in vivo CAR-T therapies for oncology and autoimmune diseases, today announced encouraging initial data from an investigator-initiated, first-in-human study of GT801, a T-LNP/mRNA–based in vivo…

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PR Newswire broke the news in United States on Saturday, December 6, 2025.
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