Qihan Biotech Receives FDA Clearance for QT-019B, First Universal Dual-Target CAR-T Therapy for Refractory Lupus
Key Insights
The FDA has cleared Qihan Biotech (search)'s IND application for QT-019B (search), enabling a Phase 1/2 clinical trial for refractory systemic lupus erythematosus (search) in the United States.
QT-019B (search) is an off-the-shelf allogeneic CAR-T therapy targeting both CD19 (search) and BCMA (search) antigens, engineered with gene editing to reduce immune rejection and enhance persistence.
The therapy has shown promising results in investigator-initiated clinical studies in China against multiple refractory autoimmune diseases (search), including systemic lupus erythematosus (search).
Hangzhou Qihan Biotech Co., Ltd. (search) has achieved a significant regulatory milestone with the U.S. Food and Drug Administration clearing its Investigational New Drug application for QT-019B (search), a universal dual-target CAR-T cell therapy designed to treat refractory systemic lupus erythematosus (search). The clearance enables the initiation of a Phase 1/2 clinical trial in the United States, marking a significant milestone in the development of novel cell-based therapies for autoimmune diseases (search).
Novel Dual-Target Approach for Autoimmune Disease
QT-019B (search) represents an innovative approach to treating refractory systemic lupus erythematosus (search) through its dual-targeting mechanism. The off-the-shelf allogeneic CAR-T cell therapy is derived from healthy donor leukapheresis products and engineered through gene editing to stably express two distinct chimeric antigen receptors targeting CD19 (search) and BCMA (search), enabling simultaneous recognition and elimination of cells expressing either antigen.
"QT-019B (search) is our first fully in-house CAR-T therapy with global rights," said Dr. Luhan Yang, Founder and CEO of Qihan Biotech (search). "In investigator-initiated clinical studies in China, it has shown promising results against multiple refractory autoimmune diseases (search), including systemic lupus erythematosus (search)."
Advanced Engineering for Enhanced Safety and Efficacy
The therapy incorporates sophisticated gene editing techniques to address key challenges in allogeneic cell therapy. To reduce the risk of graft-versus-host disease (search), the T cell receptor is knocked out. Additionally, multiplexable gene editing is employed to induce hypoimmunity, meaning the CAR-T cells are less likely to be recognized and attacked by the patient's own NK and T cells, thereby reducing immune rejection and cytotoxicity while enhancing persistence.
Addressing Significant Unmet Medical Need
Dr. Yang emphasized the critical need for new treatment options in this patient population. "Patients with refractory SLE continue to face significant unmet medical needs," she stated. "With a clear regulatory pathway and a strong likelihood of trial success, Qihan is confident in advancing QT-019B (search) rapidly into clinical studies and registration-enabling trials in pursuit of marketing approval."
The company has developed a well-defined global clinical development plan and positions QT-019B (search) as a potential breakthrough therapy that could transform the treatment landscape for refractory autoimmune diseases (search), providing safe, effective, and affordable options for patients worldwide.
Pipeline Development and Future Outlook
Beyond QT-019B (search), Qihan Biotech (search) is developing next-generation off-the-shelf CAR-T therapies that will not require patients to undergo lymphodepletion. This advancement could significantly improve patient experience and expand treatment accessibility.
The company's broader mission focuses on using high-throughput, multiplexable genome editing combined with expertise in transplantation immunology to create immunologically privileged allogeneic cells and xenogeneic organs for treating cancer, autoimmune diseases (search), organ failure, and other complex medical conditions. Qihan Biotech (search) has multiple products at different stages of development, including QN-019a, which has already received IND approval from China NMPA to treat CD19 (search)-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (search).