GT719 / Grit Biotechnology - LARVOL DELTA

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Grit Biotechnology | Initiation date: May 2026 ➔ Aug 2027

Trial initiation date • ANCA Vasculitis • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease • Vasculitis • CD19

Safety and efficacy of GT719, an off-the-shelf CAR-NKT therapy, in adults with relapsed or refractory CD19-positive B-cell malignancies. (ASCO 2026) - P1, P1/2 | "GT719 demonstrated a favorable safety profile and encouraging antitumor activity in adults with R/R CD19-positive B-cell malignancies. The absence of severe GT719-related toxicities and evidence of durable cellular persistence support further clinical investigation of this off-the-shelf CAR-NKT therapy. Clinical trial information: NCT06948981, NCT07131254."

Clinical • Acute Lymphocytic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD19 • IL15

Stem cell-derived allogeneic anti-CD19 CAR-iNKT cell therapy GT719 for relapsed/refractory B cell malignancies (AACR 2026) - P1/2 | "Enrolled patients undergo a standard lymphodepletion regimen consisting of cyclophosphamide and fludarabine from Day -5 to Day -2, consistent with protocols used for autologous CAR-T therapies. Although the trial is ongoing, we anticipate presenting preliminary safety and efficacy data for GT719 at the meeting. Clinical trial registration number: NCT06948981"

First-in-human • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD34

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Grit Biotechnology | Initiation date: Jan 2026 ➔ May 2026

Trial initiation date • ANCA Vasculitis • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Multiple Myeloma • Nephrology • Renal Disease • Vasculitis • CD19

GT719 Injection for Moderate to Severe Refractory Autoimmune Disease (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Grit Biotechnology | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Grit Biotechnology

New P1 trial • ANCA Vasculitis • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Multiple Myeloma • Nephrology • Renal Disease • Vasculitis • CD19

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: Grit Biotechnology | Phase classification: P1/2 ➔ P1 | Initiation date: Sep 2024 ➔ Mar 2025

Phase classification • Trial initiation date • Hematological Malignancies • Leukemia • Lymphoma • Oncology

First-in-human trial of GT719, a novel stem cell-derived allogeneic anti-CD19 CAR-iNKT cell therapy for relapsed/refractory B cell malignancies (ASH 2025) - P1/2 | "Lymphodepletion with cyclophosphamide and fludarabine is administered from Day –5 to Day –2. Summary: This first-in-human investigator-initiated trial evaluates the safety, DLTs, and recommended dose of GT719 for patients with CD19+ B cell malignancies. Preliminary safety data will be presented at the meeting."

First-in-human • IO biomarker • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD34

GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Grit Biotechnology | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies (clinicaltrials.gov) - P1/2 | N=46 | Recruiting | Sponsor: Grit Biotechnology | N=34 ➔ 46

Enrollment change • Hematological Malignancies • Leukemia • Lymphoma • Oncology

GT719 Injection for CD19 Positive Recurrent/Refractory Adult B-cell Malignancies (clinicaltrials.gov) - P1/2 | N=34 | Recruiting | Sponsor: Grit Biotechnology

New P1/2 trial • Hematological Malignancies • Leukemia • Lymphoma • Oncology

GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Grit Biotechnology

New P1 trial • Immunology

GT719 Injection for Moderate to Severe Refractory Autoimmune Disease (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Grit Biotechnology

New P1 trial • Immunology

GT719 Injection for Recurrent/Refractory Antibody Mediated Systemic Immune Diseases (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Grit Biotechnology

New P1 trial • CNS Disorders • Immunology