GT801 / Grit Biotechnology - LARVOL DELTA

Precision In Vivo CAR-T generation via CLAMP-enabled mRNA delivery: Toward scalable and translatable cell therapy (ASH 2025) - "Toward this goal, we report the development andpreclinical evaluation of GT801, a novel anti-CD19 in vivo CAR-T candidate.GT801 was developed using novel T-cell-targeted lipid nanoparticles (T-LNP) encapsulating chemicallymodified linear mRNA encoding an anti-CD19 CAR gene...These findings demonstrate that our T-LNP platform enables efficient, targeted, and sustained in vivoCAR expression with a favorable safety profile and scalable manufacturing process. A clinical batch iscurrently in production, and a first-in-human investigator-initiated trial (IIT) in B cell malignancies isanticipated to launch in late 2025."

IO biomarker • Preclinical • Hematological Malignancies • CD19 • IL6 • TNFA

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 (PRNewswire) - "The Phase 1 investigator-initiated study is evaluating the safety, tolerability, and preliminary efficacy of repeat GT801 dosing in patients with relapsed or refractory CD19-positive B-cell malignancies. As of the November 30, 2025 data cutoff, two patients with non-Hodgkin's lymphoma had completed multiple GT801 administrations without lymphodepleting chemotherapy, demonstrating the feasibility of generating functional CAR-T cells in vivo in the absence of cytotoxic conditioning....GT801 was generally well tolerated. Both patients showed high CAR expression within circulating T cells. Durable and repeatable CAR-T expansion was observed following each GT801 administration."

First-in-human • P1 data • Non-Hodgkin’s Lymphoma

Grit Biotherapeutics Invited to Deliver Oral Presentation at ASH 2025 on Breakthrough In Vivo CAR-T Therapy GT801 (PRNewswire-Asia) - "In preclinical studies, GT801 demonstrated: >95% B-cell clearance in humanized PBMC mouse models at doses as low as 0.01 mg/kg; >80% CAR expression across tissue-resident T cells with <1% off-target delivery to myeloid and hepatic cells....Preliminary clinical data further validate efficient CAR expression, deep B-cell depletion, and repeat-dose tolerability, highlighting GT801's strong potential as a scalable, off-the-shelf immunotherapy candidate."

Clinical data • Preclinical • Hematological Malignancies

A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-positive B-cell Hematologic Malignancies (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Grit Biotechnology

New P1 trial • Hematological Malignancies • Leukemia • Lymphoma • Oncology