BoRuida Biotech's BRD-01 Becomes China's First CD30-Targeted CAR-T Therapy Approved for Clinical Trials

On April 20, Bio-Raid’s BRD-01, an autologous T-cell injection product featuring CD30-targeted chimeric antigen receptor (CAR) gene modification, received clinical trial approval for the treatment of CD30-positive relapsed/refractory hematologic malignancies in patients aged 18 to 70 years. This marks the first CAR-T cell therapy targeting CD30 to receive clinical trial approval in China.

CD30, also known as TNFRSF8, is a cell surface glycoprotein with a molecular weight of 120 kDa. It belongs to the tumor necrosis factor receptor family and is highly expressed on the surface of Hodgkin lymphoma, anaplastic large cell lymphoma, and other CD30+ lymphoma cells, while its expression on normal cells and tissues is very low or absent.

BRD-01 is composed of a murine single-chain variable fragment (scFv) that specifically recognizes the extracellular domain of CD30, fused with the intracellular signaling domains of CD28, 4-1BB, and CD3ζ. The CD3ζ domain initiates T cell activation and antitumor activity, inducing apoptosis in CD30+ cells through the release of granzymes, perforin, and various cytokines. The intracellular signaling domains of CD28 and 4-1BB enhance the in vivo expansion, survival, and antitumor efficacy of anti-CD30 CAR-T cells. Upon binding of the CAR scFv to CD30+ cells, signals are transmitted to promote the activation and proliferation of anti-CD30 CAR-T cells, enhance their survival, and mediate the clearance of target cells.

Exploratory clinical trial results indicated that among the 13 subjects treated with BRD-01, 11 achieved complete response (CR), 1 achieved partial response (PR), and 1 had stable disease (SD). The objective response rate (ORR; CR+PR) was 92.3%, and the CR rate was 84.6%. Among the followed-up subjects, the longest duration of response reached 38 months. Cytokine release syndrome (CRS) occurred in 84.6% (11/13) of patients, with incidences of Grade 1 and Grade 2 CRS being 76.9% (10/13) and 7.7% (1/13), respectively. No Grade 3–5 CRS was observed, and no neurotoxicity was reported.