Guangzhou Bio-gene Starts Phase I Trial for CLL-1 CAR-T BG1805

GUANGZHOU, China, May 02, 2024 - Guangzhou Bio-gene Technologies, a biotechnology firm focused on creating and advancing novel cell therapies for blood cancers and solid tumors, has announced the treatment of the first patient with BG1805. This investigational autologous CAR-T cell therapy targets CLL-1, a member of the C-type lectin-like receptor family. The therapy is currently under evaluation in a Phase 1 clinical trial for relapsed or refractory acute myeloid leukemia (AML), which is a severe condition affecting both adults and children.

Dr. Min Luo, the Chief Technology Officer of Guangzhou Bio-gene Technologies, expressed enthusiasm about the progress of BG1805. "CLL-1 is a significant target for AML treatment. We are highly encouraged by the preclinical progress of BG1805 and the early data from Investigator-Initiated Trials (IIT)," he stated. Dr. Luo further noted that BG1805 is the first cell therapy in the company's pipeline to advance into formal clinical development, marking a major milestone.

The Phase 1 trial of BG1805, which is ongoing, is a multicenter, open-label study involving patients with relapsed or refractory AML. The primary objectives are to assess safety and tolerability, as well as to identify the recommended Phase 2 dose and lymphodepletion regimen. Key safety endpoints of this trial include treatment-emergent and treatment-related adverse events. Efficacy endpoints include the proportion of patients with complete or partial responses, the proportion eligible for hematopoietic stem cell transplants, and the proportion achieving minimal residual disease-negative status. Several sites for the Phase 1 clinical trial are currently open for patient enrollment.

Guangzhou Bio-gene Technologies is also developing several other autologous CAR-T cell therapies targeting significant blood malignancies and solid tumors. These include therapies directed at CD7, GPRC5D, B7H3, Claudin18.2, and CDH17. Additionally, the company is working on allogenic CAR-γδT therapies targeting CD19 and CLL-1/CD33.

BG1805, an investigational autologous CAR-T cell therapy, is specifically designed to target CLL-1 and is currently being evaluated in a Phase 1 clinical study. Previous studies, particularly Investigator-Initiated Studies (IIT), have shown that BG1805 is highly effective in treating both adult and pediatric patients.

Guangzhou Bio-gene Technologies, headquartered in Guangzhou, China, is a biotechnology company dedicated to the discovery, development, and delivery of innovative cell therapies for treating blood malignancies and solid tumors. The company is a leader in the field of CAR-T cell therapies and has successfully advanced one autologous CAR-T candidate into Phase 1 clinical trials. Additionally, the company has six autologous CAR-T candidates and two allogenic CAR-T candidates in Investigator-Initiated Trials studies.