By Fineline Cube 
Hangzhou Qihan Biotech Co., Ltd. announced that its self-developed universal dual-target CAR-T cell product, QT-019B, has received official Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This marks a significant milestone as the first universal CAR-T cell product for autoimmune diseases developed by a Chinese company to receive clinical trial approval from the FDA.
Clinical Trial Plans
Qihan Biotech plans to conduct a Phase I/II clinical trial in the United States for QT-019B to treat refractory systemic lupus erythematosus (rSLE). The primary clinical research site will be the Hospital of the University of Pennsylvania.
Product Profile
QT-019B is an “off-the-shelf” allogeneic CAR-T cell product. Its cells are derived from leukapheresis products from healthy donors. Through gene editing, the cells are engineered to stably express two different chimeric antigen receptors (CARs) targeting CD19 and BCMA. This dual-target design allows QT-019B to simultaneously recognize and eliminate cells expressing both CD19 and BCMA.
Safety and Innovation
To reduce the risk of graft-versus-host disease (GvHD), QT-019B’s T-cell receptor (TCR) expression is eliminated via gene knockout. Qihan Biotech employs multi-gene editing to achieve low immunogenicity, thereby reducing recognition and cytotoxicity mediated by the patient’s own NK and T cells.-Fineline Info & Tech