By Fineline Cube 
China-based Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) announced that its joint venture with PersonGen BioTherapeutics (Suzhou) Co. Ltd and PersonGenAnke Cellular Therapeutics Co., Ltd has secured clinical trial approval from China’s National Medical Products Administration (NMPA) for UTAA09 (UCAR-Vδ1T), a CD19-targeted allogeneic CAR-T therapy. The approval applies to the treatment of relapsed/refractory (r/r) acute B-lymphoblastic leukemia (B-ALL).
Technological Breakthroughs
UTAA09 stands out as the world’s first allogeneic CAR-T product derived from single-donor peripheral blood collections. It incorporates three key technological advancements: a γδ-T cell-based platform utilizing the Vδ1T subset, which has inherent tumor-targeting properties; non-viral vector gene editing to enhance genomic safety; and an off-the-shelf cryopreserved formulation for immediate use. These innovations position UTAA09 as a significant advancement in cancer immunotherapy.
Clinical Trial and Previous Recognition
The therapy received Breakthrough Therapy Designation from the NMPA in 2023 for r/r B-ALL. This designation underscores the potential of UTAA09 to address unmet medical needs in patients with this aggressive form of leukemia.-Fineline Info & Tech