GT801 / Grit Biotechnology, Vivacta Biotechnology - LARVOL DELTA

First-in-human study of in vivo CAR-T therapy GT801 in adults with relapsed or refractory CD19-positive B-cell hematologic malignancies. (ASCO 2026) - P1 | "Premedication included dexamethasone, NSAIDs, antihistamines. GT801 demonstrated a manageable safety profile and early signs of antitumor activity in heavily pretreated B-NHL patients. The ability to generate functional CAR-T cells in vivo without lymphodepletion supports further clinical evaluation of GT801 as a promising therapeutic approach. Clinical trial information: NCT07205315."

CAR T-Cell Therapy • First-in-human • IO biomarker • P1 data • Preclinical • Hematological Malignancies • Oncology • CD8

A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Vivacta Biotechnology (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Vivacta Biotechnology (Shanghai) Co., Ltd.

New P1 trial • Immunology

Targeted mRNA-LNP Delivery Enables In Vivo CAR-T Generation by GT801 with Potent B-Cell Depletion in Humans (ASGCT 2026) - "Robust preclinical B-cell depletion, together with preliminary clinical evidence of high in vivo CAR expression and repeat dosing feasibility, supports GT801 as a promising in vivo CAR-T therapeutic candidate. Ongoing patient enrollment and follow- up will further define its clinical utility across hematologic and autoimmune indications."

CAR T-Cell Therapy • IO biomarker • Preclinical • Hematological Malignancies • Immunology

In vivo CAR-T T-LNP system (GT801) drives potent B cell depletion and clinical feasibility in hematologic and autoimmune conditions (AACR 2026) - "These findings demonstrate that our T-LNP platform enables efficient, targeted, and sustained in vivo CAR expression with a favorable safety profile and scalable manufacturing. The platform's robust preclinical B cell depletion efficacy, validated by preliminary clinical data confirming high in vivo CAR expression and repeat dosing feasibility, successfully validates the system for clinical use. Ongoing patient accrual will further inform clinical outcomes."

CAR T-Cell Therapy • IO biomarker • Preclinical • Hematological Malignancies • Oncology • IL6 • TNFA

In vivo CAR-T T-LNP system (GT801) drives potent B cell depletion and clinical feasibility in hematologic and autoimmune conditions (SITC-SSC 2026) - No abstract available

CAR T-Cell Therapy • Preclinical • Immunology

A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate-to-Severe Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Grit Biotechnology

New P1 trial • Immunology • MPO

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