Qihan Bio Announces FDA IND Approval of First-in-Class Allogeneic Dual-Target CAR-T Therapy QT-019B for Autoimmune Diseases
Qihan Biotech
Gene Editing Technology Developer
On August 13, Hangzhou Qihan Biotech Co., Ltd. announced that the Investigational New Drug (IND) application for its self-developed first universal dual-target CAR-T cell product, QT-019B, has been officially approved by the U.S. Food and Drug Administration (FDA).
QT-019B is the first universal CAR-T cell product independently developed by a Chinese company for the treatment of autoimmune diseases to receive approval from the U.S. FDA for clinical trials. The company plans to conduct a Phase 1/2 clinical trial in the United States using QT-019B to treat refractory systemic lupus erythematosus (rSLE), with the primary clinical research site being the Hospital of the University of Pennsylvania.
QT-019B Cell Injection is an "off-the-shelf" allogeneic CAR-T cell product developed by Hangzhou Qihan Biotech Co., Ltd. QT-019B cells are derived from the leukapheresis products of healthy donor peripheral blood as the starting material, and are genetically edited to stably express two different chimeric antigen receptors (CARs), targeting CD19 and BCMA respectively, thereby enabling QT-019B to simultaneously recognize and eliminate cells expressing CD19 and BCMA.
To reduce the risk of graft-versus-host disease (GvHD), the product eliminates the expression of T-cell receptors (TCR) through gene knockout; meanwhile, to minimize allogeneic immune rejection, Hangzhou Qihan Biotech Co., Ltd. achieves low immunogenicity via multi-gene editing, thereby reducing the recognition and cytotoxic effects mediated by the patient's own NK cells and T cells.
"Qihan Biotech has established the development of universal cell therapy for autoimmune diseases as a strategic priority for the company," said Dr. Luhan Yang, the company's founder and CEO. "QT-019B is the first universal CAR-T cell product independently developed by the company with global rights. Currently, in clinical studies initiated by investigators in China, this product has demonstrated promising clinical efficacy against various refractory autoimmune diseases, including rSLE. Considering multiple factors, the company has decided to prioritize the development of QT-019B for the treatment of refractory systemic lupus erythematosus (SLE). Qihan Biotech is also honored to have established a collaboration with Dr. Carl June’s team at the University of Pennsylvania and the Department of Rheumatology and Immunology."
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