BeiGene Biologics' Off-the-Shelf Allogeneic CAR-T Therapy CTA101 Receives IND Acceptance from China's CDE

On December 24, Bioheng Biotech announced that the New Drug Clinical Trial Application for its self-developed CTA101 UCAR-T (Universal CAR-T) Cell Injection product has been accepted by the CDE (Acceptance No.: CXSL2101509). This is the first immunotherapy product in China based on CRISPR gene-editing technology and also the first "off-the-shelf" allogeneic CAR-T innovative drug in China, classified as a Class 1 new therapeutic biologic.

UCAR-T is prepared using T cells from healthy individuals. Compared to autologous CAR-T, UCAR-T has the advantages of high anti-tumor activity, low cost, and high accessibility. Universal immune cell therapy does not require matching, can be stored "off-the-shelf" and used immediately, significantly reducing the patient's treatment cycle. Cells from one healthy donor can be used to prepare hundreds or even thousands of "off-the-shelf" doses, which can significantly reduce the cost of cell therapy.

CTA101 is a dual-target UCAR-T cell injection targeting CD19 and/or CD22 positive adult relapsed/refractory acute lymphoblastic leukemia. The product utilizes Bioheng Biotech's first-generation UCAR-T platform, combined with CRISPR gene editing technology, to knock out the TRAC gene to prevent graft-versus-host disease (GvHD), while also knocking out the CD52 gene and using an anti-CD52 monoclonal antibody to avoid patient rejection of CAR-T cells (HvG), thereby extending the in vivo persistence of UCAR-T cells. In April 2021, the results of CTA101’s exploratory clinical research (IIT) were published as an original article in Clinical Cancer Research, with preliminary data showing that CTA101 has good safety and efficacy.