BRL-301 / BRL Medicine - LARVOL DELTA

Allogeneic CD19-targeted CAR-T Therapy for refractory Systemic Lupus Erythematosus (SLE) (ASGCT 2026) - P=N/A | "In this study, a healthy donor-derived, multiplex genome-edited allogeneic CD19-targeted CAR-T product (TyU19, also called as BRL-303) was developed for refractory SLE patients...Participants were screened and underwent lymphodepletion chemotherapy with cyclophosphamide (300 mg/m², day -5 to -4) and fludarabine (25 mg/m², day -5 to -3), then TyU19 infusion at day 0 with a dose level of 1×106 cells/kg. Prior to enrollment, Patient S04 was treated with telitacicept, necessitating a 6-week washout period...All of them developed grade 1 CRS for 2 or 3 days, which recovered soon without tocilizumab and steroid usage...H. Changes of anti-dsDNA antibodies, complement factor C3, complement factor C4, and 24h urine protein after TyU19 cells infusion."

CAR T-Cell Therapy • Alopecia • Graft versus Host Disease • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Musculoskeletal Pain • Neutropenia • Renal Disease • Systemic Lupus Erythematosus • Vasculitis • CD21 • CD27 • ITGAX • SDC1

Allogeneic CD19-targeted CAR-T therapy (BRL-301) for relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). (ASCO 2026) - P1 | " In this investigator-initiated trial (NCT05381181), patients with r/r B-ALL received lymphodepletion with etoposide, cyclophosphamide, and fludarabine followed by BRL-301 infusion...All patients experienced mild (grade 1/2) cytokine release syndrome; 4 patients received tocilizumab and steroids... BRL-301 demonstrated promising efficacy and a manageable safety profile in patients with r/r B-ALL, with no evidence of GvHD or severe neurotoxicity. These results support further development of allogeneic CAR-T therapy as a viable treatment option for r/r B-ALL."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia

Universal CAR-T Cell Therapy for NHL (clinicaltrials.gov) - P=N/A | N=6 | Recruiting | Sponsor: Bioray Laboratories

New trial • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases (clinicaltrials.gov) - P=N/A | N=15 | Enrolling by invitation | Sponsor: Bioray Laboratories | Recruiting ➔ Enrolling by invitation

CAR T-Cell Therapy • Enrollment status • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis • CD19

Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P=N/A | N=12 | Recruiting | Sponsor: Bioray Laboratories | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P=N/A | N=12 | Not yet recruiting | Sponsor: Bioray Laboratories

CAR T-Cell Therapy • New trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

U-CART: Safety and Efficacy Evaluation of CD19-UCART (clinicaltrials.gov) - P=N/A | N=20 | Suspended | Sponsor: Bioray Laboratories | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Bangyao Bio’s new generation of universal CAR-T therapy has been approved by IND in China [Google translation] (Medvalley.cn) - "Recently, according to the information on the official website of the Center for Drug Evaluation of the State Food and Drug Administration, Bangyao Bio-targeted CD19 gene-modified allogeneic chimeric antigen receptor T cell injection (pipeline code: BRL-301) has obtained implicit permission for clinical trials. The indication is acute lymphoblastic leukemia....BRL-301 is a new generation of UCAR-T product developed by Bangyao Biotechnology based on the self-developed universal cell platform (TyUCell®)."

New trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases (clinicaltrials.gov) - P=N/A | N=15 | Recruiting | Sponsor: Bioray Laboratories

CAR T-Cell Therapy • New trial • Fibrosis • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis • CD19

U-CART: Safety and Efficacy Evaluation of CD19-UCART (clinicaltrials.gov) - P=N/A | N=20 | Suspended | Sponsor: Bioray Laboratories | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Safety and Efficacy Evaluation of Next-generation CD19-UCART (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Bioray Laboratories | Initiation date: Dec 2022 ➔ Dec 2023

CAR T-Cell Therapy • Trial initiation date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD19

Safety and Efficacy Evaluation of Next-generation CD19-UCART (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Bioray Laboratories | Initiation date: Jun 2022 ➔ Dec 2022

CAR T-Cell Therapy • Trial initiation date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD19

U-CART: Safety and Efficacy Evaluation of CD19-UCART (clinicaltrials.gov) - P=N/A | N=20 | Suspended | Sponsor: Bioray Laboratories | Recruiting ➔ Suspended

Trial suspension • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Safety and Efficacy Evaluation of Next-generation CD19-UCART (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Bioray Laboratories

CAR T-Cell Therapy • New P1 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD19

U-CART: Safety and Efficacy Evaluation of CD19-UCART (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Bioray Laboratories | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

U-CART: Safety and Efficacy Evaluation of CD19-UCART (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: Bioray Laboratories; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

U-CART: Safety and Efficacy Evaluation of CD19-UCART (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: Shanghai Bioray Laboratory Inc.; Trial primary completion date: Aug 2020 ➔ Dec 2020

Clinical • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19