BG1805: A Comprehensive Clinical and Scientific Profile of an Investigational Anti-CLL1 CAR-T Cell Therapy for Acute Myeloid Leukemia

Executive Summary

This report provides a comprehensive analysis of BG1805, an investigational, autologous Chimeric Antigen Receptor (CAR) T-cell therapy developed by Guangzhou Bio-gene Technology Co., Ltd., for the treatment of acute myeloid leukemia (AML).[1] As a biotech therapeutic, BG1805 represents a significant advancement in the application of cell and gene therapy to myeloid malignancies, a field that has historically faced challenges due to a lack of suitable tumor-specific antigens.

The core therapeutic strategy of BG1805 is centered on the targeting of C-type lectin-like molecule-1 (CLL1), also known as CLEC12A. The selection of this target is highly strategic, as CLL1 is preferentially expressed on AML blasts and, critically, on leukemic stem cells (LSCs) which are responsible for disease relapse.[3] Concurrently, CLL1 demonstrates low or absent expression on normal hematopoietic stem cells (HSCs), offering a potential therapeutic window to eradicate the leukemia while preserving the patient's capacity for hematopoietic reconstitution.[3] This selective expression profile forms the fundamental basis for the therapy's anticipated efficacy and favorable safety profile.