YTS109 / BriSTAR Immunotech - LARVOL DELTA

AN EXPLORATORY STUDY OF YTS109 CELL THERAPY IN PATIENTS WITH AUTOIMMUNE HEMOLYTIC ANEMIA (EHA 2026) - P1 | "Patients with rAIHA received a single infusion of YTS109 following lymphodepletion with fludarabine (25-30 mg/m²) and cyclophosphamide (1000 mg/m²). These early results support the potential of YTS109 as an off-the-shelf immunotherapeutic option for patients with rAIHA. Longer follow-up and expansion cohorts are warranted to confirm durability and optimize dosing."

Clinical • First-in-human • IO biomarker • Anemia • Autoimmune Hemolytic Anemia • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • STAR

Comparison of Molecular Responses to Autologous and Allogeneic CD19 CAR-T Cell Therapy in Systemic Lupus Erythematosus (EULAR 2026) - P=N/A | "All patients received lymphodepletion with fludarabine and cyclophosphamide, followed by a single allogeneic YTS109 infusion on day 0. (B) Wang cohort single-cell RNA-seq (n=541,286 cells) following allogeneic CD19 STAR-T cell product infusion comparing month 3 vs. baseline. (C) Immature neutrophil signatures decrease after treatment at the RNA and protein levels."

CAR T-Cell Therapy • First-in-human • IO biomarker • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Safety and Efficacy of Allogeneic anti-CD19 STAR-T cell in Severe/Refractory Autoimmune Diseases: A phase I trial (EULAR 2026) - P=N/A | "After fludarabine/cyclophosphamide lymphodepletion, patients received YTS109. Conclusions YTS109 demonstrated a favorable safety profile and elicited broad, system-level immunomodulation beyond B-cell depletion. Updated results will be presented."

Clinical • P1 data • Fibrosis • Glomerulonephritis • Graft versus Host Disease • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • HLA-B

Research on YTS109 Cell in Patients With Recurrent/Refractory Autoimmune Hemolytic Anemia (clinicaltrials.gov) - P1 | N=13 | Not yet recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New P1 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Sjogren's Syndrome • Systemic Lupus Erythematosus • Vasculitis

A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

A Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Feb 2026

Trial completion • Trial completion date • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Systemic Lupus Erythematosus • Vasculitis

YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Children's Hospital of Fudan University

New P1 trial • ANCA Vasculitis • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Myositis • Neutropenia • Pediatrics • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

A Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia (clinicaltrials.gov) - P1 | N=13 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P1 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New P1 trial • ANCA Vasculitis • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Sjogren's Syndrome • Systemic Lupus Erythematosus • Vasculitis

Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New P1 trial • ANCA Vasculitis • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Allogeneic CD19-targeting T cells for treatment-refractory systemic lupus erythematosus: a phase 1 trial. (PubMed, Nat Med) - P=N/A | "These results demonstrate that YTS109 induced immune resetting and clinical remission, including renal structural restoration, potentially offering a promising therapy for refractory SLE with severe lupus nephritis, pending further validation. ClinicalTrials.gov registration: NCT06379646 ."

Journal • P1 data • Glomerulonephritis • Graft versus Host Disease • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • Systemic Lupus Erythematosus • HLA-B

A Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia (clinicaltrials.gov) - P1 | N=7 | Recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New P1 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Genetic Disorders • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New P1 trial • ANCA Vasculitis • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Systemic Lupus Erythematosus • Vasculitis

A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New P1 trial • ANCA Vasculitis • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New P1 trial • ANCA Vasculitis • Genetic Disorders • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura

An Clinical Study of YTS109 Cell Injection in Subjects With Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New P1 trial • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • Thrombocytopenia

A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia (clinicaltrials.gov) - P1 | N=7 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease (clinicaltrials.gov) - P=N/A | N=6 | Recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease (clinicaltrials.gov) - P=N/A | N=6 | Not yet recruiting | Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

New trial • ANCA Vasculitis • Fibrosis • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis