LCAR-AIO / Legend Biotech - LARVOL DELTA

A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases (clinicaltrials.gov) - P1 | N=37 | Recruiting | Sponsor: Wuhan Union Hospital, China | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2025 ➔ Jun 2025

Enrollment open • Trial initiation date • CNS Disorders • Immunology • Multiple Sclerosis • Myasthenia Gravis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Solid Tumor

A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia (clinicaltrials.gov) - P1 | N=10 | Terminated | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | N=20 ➔ 10 | Trial completion date: Jul 2026 ➔ Mar 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2024 ➔ Jan 2025; Achieve the proof of concept

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD20 • CD22

Targeting CD19/CD20/CD22 Triple-targeted Cell in Patients With Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=14 | Terminated | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | N=34 ➔ 14 | Trial completion date: Jun 2026 ➔ Mar 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Jan 2025; The collaborators decided to terminate this study.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD22

A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases (clinicaltrials.gov) - P1 | N=37 | Not yet recruiting | Sponsor: Wuhan Union Hospital, China

New P1 trial • CNS Disorders • Immunology • Multiple Sclerosis • Myasthenia Gravis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Solid Tumor

A Study of LCAR-AIO in Subjects with Relapsed/Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Nanjing Legend Biotech Co.

New P1 trial • Immunology

A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: Wuhan Union Hospital, China | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study of LCAR-AIO in Subjects with Relapsed/Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=34 | Not yet recruiting | Sponsor: Wuhan Union Hospital, China

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Recruiting ➔ Active, not recruiting | N=34 ➔ 20

Enrollment change • Enrollment closed • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD20 • CD22

A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19 • CD20 • CD22

Targeting CD19/CD20/CD22 Triple-targeted Cell in Patients With Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: Qiu Lugui

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20 • CD22

A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia (clinicaltrials.gov) - P1 | N=34 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital

New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19 • CD20 • CD22

Tri-Specific CD19xCD20xCD22 VHH CAR-T Cells (LCAR-AIO) Eradicate Antigen-Heterogeneous B Cell Tumors, Enhance Expansion, and Prolong Persistence in Preclinical In Vivo Models (ASH 2021) - "Based on in vitro and in vivo preclinical data, tri-specific CD19xCD20xCD22 VHH CAR-T can be effective targeting tumors lack of CD19 expression, therefore, it has the potential of treating relapsed patients with prior CD19 CAR-T therapy. The feasibility of making tri-specific CAR-T would help to extend this technology to solid cancers where heterogeneity poses a major challenge at current stage."

CAR T-Cell Therapy • Heterogeneity • IO biomarker • Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • IFNG

Legend Biotech Reports Third Quarter 2021 Financial Results and Recent Highlights (Businesswire) - "Key Upcoming Milestones...New and updated data from the CARTITUDE Clinical Development Program will be presented at the 63rd ASH Annual Meeting and Exposition taking place from December 11-14, 2021. Highlights include...CARTITUDE-1 updated results from the Phase 1b/2 study of cilta-cel in patients with relapsed or refractory multiple myeloma (RRMM); CARTITUDE-2 first data in patients with multiple myeloma and early relapse after initial therapy (Cohort B) and updated data in lenalidomide-refractory patients with progressive multiple myeloma after 1-3 prior lines of therapy (Cohort A); First preclinical in vivo data for novel tri-specific single-domain antibody (VHH) CAR-T cells; Legend Biotech’s collaboration partner, Janssen, anticipates submitting a New Drug Application (NDA) to the Japan Pharmaceuticals and Medical Devices Agency in Q4 2021, seeking approval of cilta-cel for the treatment of adults with RRMM."

Japanese regulatory • P1/2 data • P2 data • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Legend Biotech Showcases Updated and New Data from Comprehensive BCMA CAR-T, Cilta-Cel, Program and First Preclinical Results for Tri-specific CAR-T at 2021 ASH (Businesswire) - "Updated data from the pivotal CARTITUDE-1 study of cilta-cel in heavily pretreated adults with multiple myeloma will be featured in an oral presentation; First look at data from Cohort B of the CARTITUDE-2 study of cilta-cel in earlier lines of treatment, as well as updated data from Cohort A; First preclinical data for tri-specific VHH CAR-T (LCAR-AIO), showing potential to treat B-cell malignancies in in vivo and in vitro models, will be presented."

P1/2 data • P2 data • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology