Micotar Biologics Announces First-in-Human Clinical Data of In Vivo CAR-T Therapy GT801 for Non-Hodgkin Lymphoma

Dec 08, 2025 23:59 CST Updated Dec 09, 00:00

Vivacta

Cell Therapy Researcher

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On December 6, 2025, IVACTA Biotechnology (a biotechnology company spun off from Grail Bio, focusing on the development of in vivo CAR-T therapies for cancer and autoimmune diseases) announced positive data from the GT801 clinical trial initiated by investigators (IIT study).

GT801 is an innovative anti-CD19 in vivo CAR product that delivers optimized mRNA through T cell-targeting LNP. In a Phase I investigator-initiated clinical trial, the safety, tolerability, and preliminary efficacy of GT801 were evaluated in patients with relapsed/refractory CD19-positive B-cell lymphoma under repeat dosing conditions.

Data reported as of November 30, 2025: Two non-Hodgkin lymphoma patients successfully completed multiple administrations of GT801 without receiving lymphodepletion pretreatment. The first enrolled patient received three infusions of the GT801 product at 0.5 mg each time, while the second patient underwent four administrations at 1.5 mg per dose. Overall clinical tolerance was favorable, with high CAR expression levels observed in peripheral blood T cells. Persistent and reproducible CAR-T expansion was noted after each administration. No CAR expression was detected in peripheral blood mononuclear cells, indicating no off-target delivery risk for GT801. These findings confirm that the T-LNP delivery platform ensures enhanced targeting efficiency while avoiding non-specific uptake.

GT801 demonstrated rapid and efficient pharmacokinetics, effectively depleting B cells in peripheral blood and various tissues. Bone marrow and lymph node biopsies from both patients showed significant B cell clearance. By the fourth week after multiple dosing, both patients achieved partial remission.

Source: Grail Biotechnology

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